Page last updated: 2024-11-10

vinorelbine

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators
FloraRankFlora DefinitionFamilyFamily Definition
VincagenusA plant genus of the family Apocynaceae.[MeSH]ApocynaceaeThe dogbane family of the order Gentianales. Members of the family have milky, often poisonous juice, smooth-margined leaves, and flowers in clusters.[MeSH]

Cross-References

ID SourceID
PubMed CID5311497
CHEMBL ID553025
CHEBI ID480999
SCHEMBL ID4765
MeSH IDM0097344

Synonyms (65)

Synonym
anx-530
sdp-012
exelbine
vinorelbine [inn:ban]
c'-norvincaleukoblastine, 3',4'-didehydro-4'-deoxy-
nor-5'-anhydrovinblastine
aspidospermidine-3-carboxylic acid, 4-(acetyloxy)-6,7-didehydro-15-((2r,6r,8s)-4-ethyl-1,3,6,7,8,9-hexahydro-8-(methoxycarbonyl)-2,6-methano-2h-azecino(4,3-b)indol-8-yl)-3-hydroxy-16-methoxy-1-methyl-, methyl ester, (2beta,3beta,4beta,5alpha,12r,19alpha)-
aspidospermidine-3-carboxylic acid, 4-(acetyloxy)-6,7-didehydro-15-((2r,6r,8s)-4-ethyl-1,3,6,7,8,9-hexahydro-8-(methoxycarbonyl)-2,6-methano-2h-azecino(4,3-b)indol-8-yl)-3-hydroxy-16-methoxy-1-methyl-, methyl ester, (2beta,3beta,4beta,5alpha,12beta,19alph
kw 2307 base
vinorelbinum [latin]
navelbine base
5'-noranhydrovinblastine
DB00361
navelbine (tn)
5'-nor-anhydrovinblastine
71486-22-1
methyl (2b,3b,4b,5a,12b,19a)-4-(acetyloxy)-15-[(6r,8s)-4-ethyl-8-(methoxycarbonyl)-1,3,6,7,8,9-hexahydro-2,6-methanoazecino[4,3-b]indol-8-yl]-3-hydroxy-16-methoxy-1-methyl-6,7-didehydroaspidospermidine-3-carboxylate
HMS2090E13
D08680
vinorelbine (inn)
FT-0657343
vinorelbinum
vinorelbina
methyl (2beta,3beta,4beta,5alpha,12beta,19alpha)-4-acetoxy-15-[(6r,8s)-4-ethyl-8-(methoxycarbonyl)-1,3,6,7,8,9-hexahydro-2,6-methanoazecino[4,3-b]indol-8-yl]-3-hydroxy-16-methoxy-1-methyl-6,7-didehydroaspidospermidine-3-carboxylate
CHEBI:480999 ,
NCGC00165966-03
navelbin
CHEMBL553025
nsc-760087
nsc 760087
q6c979r91y ,
hsdb 7665
unii-q6c979r91y
vinorelbine base
vinorelbine [hsdb]
vinorelbine tartrate impurity j [ep impurity]
vinorelbine [orange book]
vinorelbine [inn]
vinorelbine [mi]
vinorelbine [who-dd]
4-deoxy-3,4-didehydrovincaleukoblastine
aspidospermidine-3-carboxylic acid, 4-(acetyloxy)-6,7-didehydro-15-((2r,6r,8s)-4-ethyl-1,3,6,7,8,9-hexahydro-8-(methoxycarbonyl)-2,6-methano-2h-azecino(4,3-b)indol-8-yl)-3-hydroxy-16-methoxy-1-methyl-, methyl ester, (2.beta.,3.beta.,4.beta.,5.alpha.,12r,1
vinorelbine [vandf]
gtpl7105
CCG-208616
SCHEMBL4765
AB01275493-01
AKOS024457606
kw-2307 base
AB01566877_01
DTXSID8040640 ,
SR-05000001504-2
SR-05000001504-1
sr-05000001504
GBABOYUKABKIAF-IELIFDKJSA-N
5' nor anhydrovinblastine
methyl (1r,9r,10s,11r,12r,19r)-11-acetyloxy-12-ethyl-4-[(12s,14r)-16-ethyl-12-methoxycarbonyl-1,10-diazatetracyclo[12.3.1.03,11.04,9]octadeca-3(11),4,6,8,15-pentaen-12-yl]-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.01,9.02,7.016,19]nonadeca
methyl (1r,9r,10s,11r,12r,19r)-11-(acetyloxy)-12-ethyl-4-[(12s,14r)-16-ethyl-12-(methoxycarbonyl)-1,10-diazatetracyclo[12.3.1.0^{3,11}.0^{4,9}]octadeca-3(11),4(9),5,7,15-pentaen-12-yl]-10-hydroxy-5-methoxy-8-methyl-8,16-diazapentacyclo[10.6.1.0^{1,9}.0^{2
EN300-19767066
3',4'-didehydro-4'-deoxy-c'-norvincaleukoblastine
dtxcid6020640
l01ca04
methyl (2beta,3beta,4beta,5alpha,12beta,19alpha)-4-acetoxy-15-((6r,8s)-4-ethyl-8-(methoxycarbonyl)-1,3,6,7,8,9-hexahydro-2,6-methanoazecino(4,3-b)indol-8-yl)-3-hydroxy-16-methoxy-1-methyl-6,7-didehydroaspidospermidine-3-carboxylate
dihydroxydeoxynorvinkaleukoblastine
vinorelbinum (latin)

Research Excerpts

Overview

Vinorelbine is a traditional chemotherapeutic agent for treatment of lung cancer and breast cancer by the selectivity to mitotic microtubules.

ExcerptReferenceRelevance
"Vinorelbine is a traditional chemotherapeutic agent for treatment of lung cancer and breast cancer by the selectivity to mitotic microtubules."( Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
Fu, Q; Liu, H; Liu, Z; Lu, Y; Sun, X; Yu, P; Zhang, W, 2020
)
1.61

Toxicity

ExcerptReferenceRelevance
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32

Pharmacokinetics

ExcerptReferenceRelevance
" Recent studies with a 103-compound dataset suggested that scaling from monkey pharmacokinetic data tended to be the most accurate method for predicting human clearance."( Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
Evans, CA; Jolivette, LJ; Nagilla, R; Ward, KW, 2006
)
0.33
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
photosensitizing agentA chemical compound that can be excited by light of a specific wavelength and subsequently transfer energy to a chosen reactant. This is commonly molecular oxygen within a cancer tissue, which is converted to (highly rective) singlet state oxygen. This rapidly reacts with any nearby biomolecules, ultimately killing the cancer cells.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (6)

ClassDescription
vinca alkaloidA group of indole-indoline dimers which are alkaloids obtained from the Vinca genus of plants, together with semi-synthetic and fully synthetic analogues.
organic heteropentacyclic compound
organic heterotetracyclic compound
methyl esterAny carboxylic ester resulting from the formal condensation of a carboxy group with methanol.
acetate esterAny carboxylic ester where the carboxylic acid component is acetic acid.
ring assemblyTwo or more cyclic systems (single rings or fused systems) which are directly joined to each other by double or single bonds are named ring assemblies when the number of such direct ring junctions is one less than the number of cyclic systems involved.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (25)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
thioredoxin reductaseRattus norvegicus (Norway rat)Potency28.18380.100020.879379.4328AID588453
TDP1 proteinHomo sapiens (human)Potency6.36530.000811.382244.6684AID686978; AID686979
Smad3Homo sapiens (human)Potency0.70790.00527.809829.0929AID588855
67.9K proteinVaccinia virusPotency4.79570.00018.4406100.0000AID720579; AID720580
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Tubulin beta-4A chainHomo sapiens (human)IC50 (µMol)1.35000.00051.968010.0000AID1194487; AID1239200
CholinesteraseHomo sapiens (human)IC50 (µMol)0.70000.00001.559910.0000AID1194487
Tubulin beta chainHomo sapiens (human)IC50 (µMol)1.35000.00052.052910.0000AID1194487; AID1239200
Cytochrome P450 3A4Homo sapiens (human)IC50 (µMol)1.00000.00011.753610.0000AID625251
Tubulin alpha-3C chainHomo sapiens (human)IC50 (µMol)1.35000.00051.955510.0000AID1194487; AID1239200
Alpha-2B adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.70000.00031.09147.7625AID1194487
Substance-K receptorHomo sapiens (human)IC50 (µMol)1.60620.00013.12109.5530AID625227
Substance-K receptorHomo sapiens (human)Ki0.53550.00011.92429.7930AID625227
Alpha-2C adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.70000.00031.09147.7625AID1194487
Alpha-2A adrenergic receptorRattus norvegicus (Norway rat)IC50 (µMol)0.70000.00031.06917.7625AID1194487
Tubulin alpha-1B chainHomo sapiens (human)IC50 (µMol)1.35000.00051.955510.0000AID1194487; AID1239200
Tubulin alpha-4A chainHomo sapiens (human)IC50 (µMol)1.35000.00051.955510.0000AID1194487; AID1239200
Tubulin beta-4B chainHomo sapiens (human)IC50 (µMol)1.35000.00051.968010.0000AID1194487; AID1239200
Tubulin beta-3 chainHomo sapiens (human)IC50 (µMol)1.35000.00051.894510.0000AID1194487; AID1239200
Tubulin beta-2A chainHomo sapiens (human)IC50 (µMol)1.35000.00051.968010.0000AID1194487; AID1239200
Tubulin beta-8 chainHomo sapiens (human)IC50 (µMol)1.35000.00051.968010.0000AID1194487; AID1239200
Tubulin alpha-3E chainHomo sapiens (human)IC50 (µMol)1.35000.00051.955510.0000AID1194487; AID1239200
Tubulin alpha-1A chainHomo sapiens (human)IC50 (µMol)1.35000.00051.955510.0000AID1194487; AID1239200
Tubulin alpha-1C chainHomo sapiens (human)IC50 (µMol)1.35000.00051.955510.0000AID1194487; AID1239200
Tubulin beta-6 chainHomo sapiens (human)IC50 (µMol)1.35000.00051.968010.0000AID1194487; AID1239200
Tubulin beta-2B chainHomo sapiens (human)IC50 (µMol)1.35000.00051.968010.0000AID1194487; AID1239200
Tubulin beta-1 chainHomo sapiens (human)IC50 (µMol)1.35000.00051.987010.0000AID1194487; AID1239200
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (94)

Processvia Protein(s)Taxonomy
negative regulation of microtubule polymerizationTubulin beta-4A chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-4A chainHomo sapiens (human)
mitotic cell cycleTubulin beta-4A chainHomo sapiens (human)
xenobiotic metabolic processCholinesteraseHomo sapiens (human)
learningCholinesteraseHomo sapiens (human)
negative regulation of cell population proliferationCholinesteraseHomo sapiens (human)
neuroblast differentiationCholinesteraseHomo sapiens (human)
peptide hormone processingCholinesteraseHomo sapiens (human)
response to alkaloidCholinesteraseHomo sapiens (human)
cocaine metabolic processCholinesteraseHomo sapiens (human)
negative regulation of synaptic transmissionCholinesteraseHomo sapiens (human)
response to glucocorticoidCholinesteraseHomo sapiens (human)
response to folic acidCholinesteraseHomo sapiens (human)
choline metabolic processCholinesteraseHomo sapiens (human)
acetylcholine catabolic processCholinesteraseHomo sapiens (human)
odontoblast differentiationTubulin beta chainHomo sapiens (human)
microtubule-based processTubulin beta chainHomo sapiens (human)
cytoskeleton-dependent intracellular transportTubulin beta chainHomo sapiens (human)
natural killer cell mediated cytotoxicityTubulin beta chainHomo sapiens (human)
regulation of synapse organizationTubulin beta chainHomo sapiens (human)
spindle assemblyTubulin beta chainHomo sapiens (human)
cell divisionTubulin beta chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta chainHomo sapiens (human)
mitotic cell cycleTubulin beta chainHomo sapiens (human)
lipid hydroxylationCytochrome P450 3A4Homo sapiens (human)
lipid metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid catabolic processCytochrome P450 3A4Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 3A4Homo sapiens (human)
steroid metabolic processCytochrome P450 3A4Homo sapiens (human)
cholesterol metabolic processCytochrome P450 3A4Homo sapiens (human)
androgen metabolic processCytochrome P450 3A4Homo sapiens (human)
estrogen metabolic processCytochrome P450 3A4Homo sapiens (human)
alkaloid catabolic processCytochrome P450 3A4Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 3A4Homo sapiens (human)
calcitriol biosynthetic process from calciolCytochrome P450 3A4Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D metabolic processCytochrome P450 3A4Homo sapiens (human)
vitamin D catabolic processCytochrome P450 3A4Homo sapiens (human)
retinol metabolic processCytochrome P450 3A4Homo sapiens (human)
retinoic acid metabolic processCytochrome P450 3A4Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 3A4Homo sapiens (human)
aflatoxin metabolic processCytochrome P450 3A4Homo sapiens (human)
oxidative demethylationCytochrome P450 3A4Homo sapiens (human)
microtubule cytoskeleton organizationTubulin alpha-3C chainHomo sapiens (human)
mitotic cell cycleTubulin alpha-3C chainHomo sapiens (human)
muscle contractionSubstance-K receptorHomo sapiens (human)
tachykinin receptor signaling pathwaySubstance-K receptorHomo sapiens (human)
positive regulation of acetylcholine secretion, neurotransmissionSubstance-K receptorHomo sapiens (human)
intestine smooth muscle contractionSubstance-K receptorHomo sapiens (human)
negative regulation of luteinizing hormone secretionSubstance-K receptorHomo sapiens (human)
operant conditioningSubstance-K receptorHomo sapiens (human)
positive regulation of vascular permeabilitySubstance-K receptorHomo sapiens (human)
positive regulation of monoatomic ion transportSubstance-K receptorHomo sapiens (human)
positive regulation of smooth muscle contractionSubstance-K receptorHomo sapiens (human)
response to electrical stimulusSubstance-K receptorHomo sapiens (human)
prolactin secretionSubstance-K receptorHomo sapiens (human)
positive regulation of uterine smooth muscle contractionSubstance-K receptorHomo sapiens (human)
positive regulation of flagellated sperm motilitySubstance-K receptorHomo sapiens (human)
microtubule cytoskeleton organizationTubulin alpha-1B chainHomo sapiens (human)
microtubule-based processTubulin alpha-1B chainHomo sapiens (human)
cytoskeleton-dependent intracellular transportTubulin alpha-1B chainHomo sapiens (human)
cell divisionTubulin alpha-1B chainHomo sapiens (human)
cellular response to interleukin-4Tubulin alpha-1B chainHomo sapiens (human)
mitotic cell cycleTubulin alpha-1B chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin alpha-4A chainHomo sapiens (human)
mitotic cell cycleTubulin alpha-4A chainHomo sapiens (human)
natural killer cell mediated cytotoxicityTubulin beta-4B chainHomo sapiens (human)
mitotic cell cycleTubulin beta-4B chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-4B chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-3 chainHomo sapiens (human)
axon guidanceTubulin beta-3 chainHomo sapiens (human)
netrin-activated signaling pathwayTubulin beta-3 chainHomo sapiens (human)
dorsal root ganglion developmentTubulin beta-3 chainHomo sapiens (human)
mitotic cell cycleTubulin beta-3 chainHomo sapiens (human)
cerebral cortex developmentTubulin beta-2A chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-2A chainHomo sapiens (human)
mitotic cell cycleTubulin beta-2A chainHomo sapiens (human)
oocyte maturationTubulin beta-8 chainHomo sapiens (human)
spindle assembly involved in female meiosisTubulin beta-8 chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-8 chainHomo sapiens (human)
mitotic cell cycleTubulin beta-8 chainHomo sapiens (human)
biological_processTubulin alpha-3E chainHomo sapiens (human)
mitotic cell cycleTubulin alpha-3E chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin alpha-3E chainHomo sapiens (human)
neuron migrationTubulin alpha-1A chainHomo sapiens (human)
startle responseTubulin alpha-1A chainHomo sapiens (human)
intracellular protein transportTubulin alpha-1A chainHomo sapiens (human)
microtubule-based processTubulin alpha-1A chainHomo sapiens (human)
centrosome cycleTubulin alpha-1A chainHomo sapiens (human)
smoothened signaling pathwayTubulin alpha-1A chainHomo sapiens (human)
memoryTubulin alpha-1A chainHomo sapiens (human)
adult locomotory behaviorTubulin alpha-1A chainHomo sapiens (human)
visual learningTubulin alpha-1A chainHomo sapiens (human)
response to mechanical stimulusTubulin alpha-1A chainHomo sapiens (human)
glial cell differentiationTubulin alpha-1A chainHomo sapiens (human)
gene expressionTubulin alpha-1A chainHomo sapiens (human)
dentate gyrus developmentTubulin alpha-1A chainHomo sapiens (human)
cerebellar cortex morphogenesisTubulin alpha-1A chainHomo sapiens (human)
pyramidal neuron differentiationTubulin alpha-1A chainHomo sapiens (human)
cerebral cortex developmentTubulin alpha-1A chainHomo sapiens (human)
cytoskeleton-dependent intracellular transportTubulin alpha-1A chainHomo sapiens (human)
response to tumor necrosis factorTubulin alpha-1A chainHomo sapiens (human)
locomotory exploration behaviorTubulin alpha-1A chainHomo sapiens (human)
microtubule polymerizationTubulin alpha-1A chainHomo sapiens (human)
forebrain morphogenesisTubulin alpha-1A chainHomo sapiens (human)
homeostasis of number of cells within a tissueTubulin alpha-1A chainHomo sapiens (human)
regulation of synapse organizationTubulin alpha-1A chainHomo sapiens (human)
synapse organizationTubulin alpha-1A chainHomo sapiens (human)
cell divisionTubulin alpha-1A chainHomo sapiens (human)
neuron apoptotic processTubulin alpha-1A chainHomo sapiens (human)
motor behaviorTubulin alpha-1A chainHomo sapiens (human)
cellular response to calcium ionTubulin alpha-1A chainHomo sapiens (human)
organelle transport along microtubuleTubulin alpha-1A chainHomo sapiens (human)
neuron projection arborizationTubulin alpha-1A chainHomo sapiens (human)
response to L-glutamateTubulin alpha-1A chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin alpha-1A chainHomo sapiens (human)
mitotic cell cycleTubulin alpha-1A chainHomo sapiens (human)
microtubule-based processTubulin alpha-1C chainHomo sapiens (human)
cytoskeleton-dependent intracellular transportTubulin alpha-1C chainHomo sapiens (human)
cell divisionTubulin alpha-1C chainHomo sapiens (human)
mitotic cell cycleTubulin alpha-1C chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin alpha-1C chainHomo sapiens (human)
mitotic cell cycleTubulin beta-6 chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-6 chainHomo sapiens (human)
neuron migrationTubulin beta-2B chainHomo sapiens (human)
microtubule-based processTubulin beta-2B chainHomo sapiens (human)
cerebral cortex developmentTubulin beta-2B chainHomo sapiens (human)
modulation of chemical synaptic transmissionTubulin beta-2B chainHomo sapiens (human)
positive regulation of axon guidanceTubulin beta-2B chainHomo sapiens (human)
embryonic brain developmentTubulin beta-2B chainHomo sapiens (human)
mitotic cell cycleTubulin beta-2B chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-2B chainHomo sapiens (human)
platelet formationTubulin beta-1 chainHomo sapiens (human)
thyroid gland developmentTubulin beta-1 chainHomo sapiens (human)
microtubule polymerizationTubulin beta-1 chainHomo sapiens (human)
spindle assemblyTubulin beta-1 chainHomo sapiens (human)
thyroid hormone transportTubulin beta-1 chainHomo sapiens (human)
platelet aggregationTubulin beta-1 chainHomo sapiens (human)
mitotic cell cycleTubulin beta-1 chainHomo sapiens (human)
microtubule cytoskeleton organizationTubulin beta-1 chainHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (51)

Processvia Protein(s)Taxonomy
GTPase activityTubulin beta-4A chainHomo sapiens (human)
calcium ion bindingTubulin beta-4A chainHomo sapiens (human)
protein bindingTubulin beta-4A chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-4A chainHomo sapiens (human)
GTP bindingTubulin beta-4A chainHomo sapiens (human)
amyloid-beta bindingCholinesteraseHomo sapiens (human)
catalytic activityCholinesteraseHomo sapiens (human)
acetylcholinesterase activityCholinesteraseHomo sapiens (human)
cholinesterase activityCholinesteraseHomo sapiens (human)
protein bindingCholinesteraseHomo sapiens (human)
hydrolase activity, acting on ester bondsCholinesteraseHomo sapiens (human)
enzyme bindingCholinesteraseHomo sapiens (human)
choline bindingCholinesteraseHomo sapiens (human)
identical protein bindingCholinesteraseHomo sapiens (human)
GTPase activityTubulin beta chainHomo sapiens (human)
structural molecule activityTubulin beta chainHomo sapiens (human)
protein bindingTubulin beta chainHomo sapiens (human)
protein domain specific bindingTubulin beta chainHomo sapiens (human)
ubiquitin protein ligase bindingTubulin beta chainHomo sapiens (human)
GTPase activating protein bindingTubulin beta chainHomo sapiens (human)
MHC class I protein bindingTubulin beta chainHomo sapiens (human)
protein-containing complex bindingTubulin beta chainHomo sapiens (human)
metal ion bindingTubulin beta chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta chainHomo sapiens (human)
GTP bindingTubulin beta chainHomo sapiens (human)
monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
steroid bindingCytochrome P450 3A4Homo sapiens (human)
iron ion bindingCytochrome P450 3A4Homo sapiens (human)
protein bindingCytochrome P450 3A4Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
retinoic acid 4-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
oxidoreductase activityCytochrome P450 3A4Homo sapiens (human)
oxygen bindingCytochrome P450 3A4Homo sapiens (human)
enzyme bindingCytochrome P450 3A4Homo sapiens (human)
heme bindingCytochrome P450 3A4Homo sapiens (human)
vitamin D3 25-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
caffeine oxidase activityCytochrome P450 3A4Homo sapiens (human)
quinine 3-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
testosterone 6-beta-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1-alpha,25-dihydroxyvitamin D3 23-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 3A4Homo sapiens (human)
aromatase activityCytochrome P450 3A4Homo sapiens (human)
vitamin D 24-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 16-alpha-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 3A4Homo sapiens (human)
1,8-cineole 2-exo-monooxygenase activityCytochrome P450 3A4Homo sapiens (human)
hydrolase activityTubulin alpha-3C chainHomo sapiens (human)
metal ion bindingTubulin alpha-3C chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin alpha-3C chainHomo sapiens (human)
GTP bindingTubulin alpha-3C chainHomo sapiens (human)
tachykinin receptor activitySubstance-K receptorHomo sapiens (human)
protein bindingSubstance-K receptorHomo sapiens (human)
substance K receptor activitySubstance-K receptorHomo sapiens (human)
double-stranded RNA bindingTubulin alpha-1B chainHomo sapiens (human)
GTPase activityTubulin alpha-1B chainHomo sapiens (human)
structural molecule activityTubulin alpha-1B chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin alpha-1B chainHomo sapiens (human)
protein bindingTubulin alpha-1B chainHomo sapiens (human)
GTP bindingTubulin alpha-1B chainHomo sapiens (human)
ubiquitin protein ligase bindingTubulin alpha-1B chainHomo sapiens (human)
protein bindingTubulin alpha-4A chainHomo sapiens (human)
hydrolase activityTubulin alpha-4A chainHomo sapiens (human)
protein kinase bindingTubulin alpha-4A chainHomo sapiens (human)
metal ion bindingTubulin alpha-4A chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin alpha-4A chainHomo sapiens (human)
GTP bindingTubulin alpha-4A chainHomo sapiens (human)
double-stranded RNA bindingTubulin beta-4B chainHomo sapiens (human)
GTPase activityTubulin beta-4B chainHomo sapiens (human)
protein bindingTubulin beta-4B chainHomo sapiens (human)
MHC class I protein bindingTubulin beta-4B chainHomo sapiens (human)
metal ion bindingTubulin beta-4B chainHomo sapiens (human)
unfolded protein bindingTubulin beta-4B chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-4B chainHomo sapiens (human)
GTP bindingTubulin beta-4B chainHomo sapiens (human)
GTPase activityTubulin beta-3 chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-3 chainHomo sapiens (human)
protein bindingTubulin beta-3 chainHomo sapiens (human)
GTP bindingTubulin beta-3 chainHomo sapiens (human)
peptide bindingTubulin beta-3 chainHomo sapiens (human)
metal ion bindingTubulin beta-3 chainHomo sapiens (human)
netrin receptor bindingTubulin beta-3 chainHomo sapiens (human)
GTPase activityTubulin beta-2A chainHomo sapiens (human)
protein bindingTubulin beta-2A chainHomo sapiens (human)
metal ion bindingTubulin beta-2A chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-2A chainHomo sapiens (human)
GTP bindingTubulin beta-2A chainHomo sapiens (human)
molecular_functionTubulin beta-8 chainHomo sapiens (human)
GTPase activityTubulin beta-8 chainHomo sapiens (human)
metal ion bindingTubulin beta-8 chainHomo sapiens (human)
GTP bindingTubulin beta-8 chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-8 chainHomo sapiens (human)
molecular_functionTubulin alpha-3E chainHomo sapiens (human)
protein bindingTubulin alpha-3E chainHomo sapiens (human)
hydrolase activityTubulin alpha-3E chainHomo sapiens (human)
metal ion bindingTubulin alpha-3E chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin alpha-3E chainHomo sapiens (human)
GTP bindingTubulin alpha-3E chainHomo sapiens (human)
structural molecule activityTubulin alpha-1A chainHomo sapiens (human)
protein bindingTubulin alpha-1A chainHomo sapiens (human)
hydrolase activityTubulin alpha-1A chainHomo sapiens (human)
identical protein bindingTubulin alpha-1A chainHomo sapiens (human)
protein-containing complex bindingTubulin alpha-1A chainHomo sapiens (human)
metal ion bindingTubulin alpha-1A chainHomo sapiens (human)
protein heterodimerization activityTubulin alpha-1A chainHomo sapiens (human)
GTP bindingTubulin alpha-1A chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin alpha-1A chainHomo sapiens (human)
structural molecule activityTubulin alpha-1C chainHomo sapiens (human)
protein bindingTubulin alpha-1C chainHomo sapiens (human)
hydrolase activityTubulin alpha-1C chainHomo sapiens (human)
metal ion bindingTubulin alpha-1C chainHomo sapiens (human)
GTP bindingTubulin alpha-1C chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin alpha-1C chainHomo sapiens (human)
molecular_functionTubulin beta-6 chainHomo sapiens (human)
GTPase activityTubulin beta-6 chainHomo sapiens (human)
protein bindingTubulin beta-6 chainHomo sapiens (human)
metal ion bindingTubulin beta-6 chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-6 chainHomo sapiens (human)
GTP bindingTubulin beta-6 chainHomo sapiens (human)
GTPase activityTubulin beta-2B chainHomo sapiens (human)
protein bindingTubulin beta-2B chainHomo sapiens (human)
metal ion bindingTubulin beta-2B chainHomo sapiens (human)
protein heterodimerization activityTubulin beta-2B chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-2B chainHomo sapiens (human)
GTP bindingTubulin beta-2B chainHomo sapiens (human)
GTPase activityTubulin beta-1 chainHomo sapiens (human)
metal ion bindingTubulin beta-1 chainHomo sapiens (human)
structural constituent of cytoskeletonTubulin beta-1 chainHomo sapiens (human)
GTP bindingTubulin beta-1 chainHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (44)

Processvia Protein(s)Taxonomy
nucleusTubulin beta-4A chainHomo sapiens (human)
cytosolTubulin beta-4A chainHomo sapiens (human)
microtubuleTubulin beta-4A chainHomo sapiens (human)
axonemeTubulin beta-4A chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-4A chainHomo sapiens (human)
internode region of axonTubulin beta-4A chainHomo sapiens (human)
neuronal cell bodyTubulin beta-4A chainHomo sapiens (human)
myelin sheathTubulin beta-4A chainHomo sapiens (human)
intercellular bridgeTubulin beta-4A chainHomo sapiens (human)
extracellular exosomeTubulin beta-4A chainHomo sapiens (human)
mitotic spindleTubulin beta-4A chainHomo sapiens (human)
microtubuleTubulin beta-4A chainHomo sapiens (human)
cytoplasmTubulin beta-4A chainHomo sapiens (human)
extracellular regionCholinesteraseHomo sapiens (human)
nuclear envelope lumenCholinesteraseHomo sapiens (human)
endoplasmic reticulum lumenCholinesteraseHomo sapiens (human)
blood microparticleCholinesteraseHomo sapiens (human)
plasma membraneCholinesteraseHomo sapiens (human)
extracellular spaceCholinesteraseHomo sapiens (human)
extracellular regionTubulin beta chainHomo sapiens (human)
nucleusTubulin beta chainHomo sapiens (human)
nuclear envelope lumenTubulin beta chainHomo sapiens (human)
cytoplasmTubulin beta chainHomo sapiens (human)
cytosolTubulin beta chainHomo sapiens (human)
cytoskeletonTubulin beta chainHomo sapiens (human)
microtubuleTubulin beta chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta chainHomo sapiens (human)
azurophil granule lumenTubulin beta chainHomo sapiens (human)
cytoplasmic ribonucleoprotein granuleTubulin beta chainHomo sapiens (human)
cell bodyTubulin beta chainHomo sapiens (human)
membrane raftTubulin beta chainHomo sapiens (human)
intercellular bridgeTubulin beta chainHomo sapiens (human)
extracellular exosomeTubulin beta chainHomo sapiens (human)
mitotic spindleTubulin beta chainHomo sapiens (human)
protein-containing complexTubulin beta chainHomo sapiens (human)
cytoplasmTubulin beta chainHomo sapiens (human)
microtubuleTubulin beta chainHomo sapiens (human)
cytoplasmCytochrome P450 3A4Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 3A4Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 3A4Homo sapiens (human)
nucleusTubulin alpha-3C chainHomo sapiens (human)
microtubule cytoskeletonTubulin alpha-3C chainHomo sapiens (human)
microtubuleTubulin alpha-3C chainHomo sapiens (human)
cytoplasmTubulin alpha-3C chainHomo sapiens (human)
plasma membraneSubstance-K receptorHomo sapiens (human)
sperm flagellumSubstance-K receptorHomo sapiens (human)
sperm headSubstance-K receptorHomo sapiens (human)
sperm midpieceSubstance-K receptorHomo sapiens (human)
sperm midpieceSubstance-K receptorHomo sapiens (human)
plasma membraneSubstance-K receptorHomo sapiens (human)
microtubule cytoskeletonTubulin alpha-1B chainHomo sapiens (human)
microtubuleTubulin alpha-1B chainHomo sapiens (human)
cytoplasmic microtubuleTubulin alpha-1B chainHomo sapiens (human)
microtubule cytoskeletonTubulin alpha-1B chainHomo sapiens (human)
microtubuleTubulin alpha-1B chainHomo sapiens (human)
cytoplasmTubulin alpha-1B chainHomo sapiens (human)
extracellular regionTubulin alpha-4A chainHomo sapiens (human)
cytosolTubulin alpha-4A chainHomo sapiens (human)
cytoskeletonTubulin alpha-4A chainHomo sapiens (human)
microtubuleTubulin alpha-4A chainHomo sapiens (human)
microtubule cytoskeletonTubulin alpha-4A chainHomo sapiens (human)
extracellular exosomeTubulin alpha-4A chainHomo sapiens (human)
cytoplasmTubulin alpha-4A chainHomo sapiens (human)
microtubuleTubulin alpha-4A chainHomo sapiens (human)
extracellular regionTubulin beta-4B chainHomo sapiens (human)
nucleusTubulin beta-4B chainHomo sapiens (human)
cytosolTubulin beta-4B chainHomo sapiens (human)
cytoskeletonTubulin beta-4B chainHomo sapiens (human)
microtubuleTubulin beta-4B chainHomo sapiens (human)
axonemal microtubuleTubulin beta-4B chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-4B chainHomo sapiens (human)
azurophil granule lumenTubulin beta-4B chainHomo sapiens (human)
intercellular bridgeTubulin beta-4B chainHomo sapiens (human)
extracellular exosomeTubulin beta-4B chainHomo sapiens (human)
mitotic spindleTubulin beta-4B chainHomo sapiens (human)
extracellular vesicleTubulin beta-4B chainHomo sapiens (human)
microtubuleTubulin beta-4B chainHomo sapiens (human)
cytoplasmTubulin beta-4B chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-3 chainHomo sapiens (human)
nucleusTubulin beta-3 chainHomo sapiens (human)
microtubuleTubulin beta-3 chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-3 chainHomo sapiens (human)
lamellipodiumTubulin beta-3 chainHomo sapiens (human)
filopodiumTubulin beta-3 chainHomo sapiens (human)
axonTubulin beta-3 chainHomo sapiens (human)
dendriteTubulin beta-3 chainHomo sapiens (human)
growth coneTubulin beta-3 chainHomo sapiens (human)
neuronal cell bodyTubulin beta-3 chainHomo sapiens (human)
intercellular bridgeTubulin beta-3 chainHomo sapiens (human)
extracellular exosomeTubulin beta-3 chainHomo sapiens (human)
cell peripheryTubulin beta-3 chainHomo sapiens (human)
mitotic spindleTubulin beta-3 chainHomo sapiens (human)
microtubuleTubulin beta-3 chainHomo sapiens (human)
cytoplasmTubulin beta-3 chainHomo sapiens (human)
nucleusTubulin beta-2A chainHomo sapiens (human)
microtubuleTubulin beta-2A chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-2A chainHomo sapiens (human)
intercellular bridgeTubulin beta-2A chainHomo sapiens (human)
extracellular exosomeTubulin beta-2A chainHomo sapiens (human)
mitotic spindleTubulin beta-2A chainHomo sapiens (human)
extracellular vesicleTubulin beta-2A chainHomo sapiens (human)
cytoplasmTubulin beta-2A chainHomo sapiens (human)
microtubuleTubulin beta-2A chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-8 chainHomo sapiens (human)
intercellular bridgeTubulin beta-8 chainHomo sapiens (human)
extracellular exosomeTubulin beta-8 chainHomo sapiens (human)
mitotic spindleTubulin beta-8 chainHomo sapiens (human)
meiotic spindleTubulin beta-8 chainHomo sapiens (human)
microtubuleTubulin beta-8 chainHomo sapiens (human)
cytoplasmTubulin beta-8 chainHomo sapiens (human)
nucleusTubulin alpha-3E chainHomo sapiens (human)
microtubule cytoskeletonTubulin alpha-3E chainHomo sapiens (human)
microtubuleTubulin alpha-3E chainHomo sapiens (human)
cytoplasmTubulin alpha-3E chainHomo sapiens (human)
condensed chromosomeTubulin alpha-1A chainHomo sapiens (human)
nucleusTubulin alpha-1A chainHomo sapiens (human)
cytosolTubulin alpha-1A chainHomo sapiens (human)
microtubuleTubulin alpha-1A chainHomo sapiens (human)
axonemal microtubuleTubulin alpha-1A chainHomo sapiens (human)
plasma membraneTubulin alpha-1A chainHomo sapiens (human)
microtubule cytoskeletonTubulin alpha-1A chainHomo sapiens (human)
neuromuscular junctionTubulin alpha-1A chainHomo sapiens (human)
cytoplasmic ribonucleoprotein granuleTubulin alpha-1A chainHomo sapiens (human)
recycling endosomeTubulin alpha-1A chainHomo sapiens (human)
extracellular exosomeTubulin alpha-1A chainHomo sapiens (human)
microtubuleTubulin alpha-1A chainHomo sapiens (human)
cytoplasmTubulin alpha-1A chainHomo sapiens (human)
nucleusTubulin alpha-1C chainHomo sapiens (human)
microtubuleTubulin alpha-1C chainHomo sapiens (human)
cytoplasmic microtubuleTubulin alpha-1C chainHomo sapiens (human)
microtubule cytoskeletonTubulin alpha-1C chainHomo sapiens (human)
vesicleTubulin alpha-1C chainHomo sapiens (human)
membrane raftTubulin alpha-1C chainHomo sapiens (human)
microtubuleTubulin alpha-1C chainHomo sapiens (human)
cytoplasmTubulin alpha-1C chainHomo sapiens (human)
nucleusTubulin beta-6 chainHomo sapiens (human)
microtubuleTubulin beta-6 chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-6 chainHomo sapiens (human)
intercellular bridgeTubulin beta-6 chainHomo sapiens (human)
extracellular exosomeTubulin beta-6 chainHomo sapiens (human)
mitotic spindleTubulin beta-6 chainHomo sapiens (human)
cytoplasmTubulin beta-6 chainHomo sapiens (human)
microtubuleTubulin beta-6 chainHomo sapiens (human)
nucleusTubulin beta-2B chainHomo sapiens (human)
microtubuleTubulin beta-2B chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-2B chainHomo sapiens (human)
intercellular bridgeTubulin beta-2B chainHomo sapiens (human)
mitotic spindleTubulin beta-2B chainHomo sapiens (human)
Schaffer collateral - CA1 synapseTubulin beta-2B chainHomo sapiens (human)
microtubuleTubulin beta-2B chainHomo sapiens (human)
cytoplasmTubulin beta-2B chainHomo sapiens (human)
cytoplasmTubulin beta-1 chainHomo sapiens (human)
microtubule cytoskeletonTubulin beta-1 chainHomo sapiens (human)
intercellular bridgeTubulin beta-1 chainHomo sapiens (human)
extracellular exosomeTubulin beta-1 chainHomo sapiens (human)
mitotic spindleTubulin beta-1 chainHomo sapiens (human)
microtubuleTubulin beta-1 chainHomo sapiens (human)
cytoplasmTubulin beta-1 chainHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (296)

Assay IDTitleYearJournalArticle
AID1628796Cell cycle arrest in human STO cells assessed as decrease in cell levels at S phase at IC50 after 48 to 72 hrs by propidium iodide staining-based flow cytometric method2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1692339Inhibition of epithelial-mesenchymal transition in human NCI-H1975 cells assessed as increase in Vimentin expression at 1 to 100 nM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1692340Inhibition of epithelial-mesenchymal transition in human NCI-H1975 cells assessed as decrease in N-cadherin expression at 1 to 100 nM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692351Inhibition of epithelial-mesenchymal transition in human HepG2 cells assessed as downregulation of MMP-9 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID540229Volume of distribution at steady state in human after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID596139Antiproliferative activity against human A431 cells after 72 hrs by sulforhodamine B assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Synthesis and biological evaluation of 2,4,5-substituted pyrimidines as a new class of tubulin polymerization inhibitors.
AID1732200Inhibition of porcine brain tubulin polymerization at 10 uM2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID1322435Inhibition of P-gp in doxorubicin-resistant human K562R cells assessed as rhodamine influx by measuring ratio of rhodamine mean fluorescence intensity in presence and absence of compound at 10 uM incubated for 20 mins by flow cytometry2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID1322432Cytotoxicity against doxorubicin-resistant human K562R cells incubated for 72 hrs by CellTiter 96 aqueous one solution reagent based assay2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID1221956Apparent permeability from apical to basolateral side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1692355Inhibition of epithelial-mesenchymal transition in human HCT-116 cells assessed as downregulation of Snail-1 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1322436Inhibition of P-gp in doxorubicin-resistant human K562R cells assessed as rhodamine efflux by measuring mean fluorescence intensity at 10 uM incubated for 1 hr by flow cytometry (Rvb = 0.47 No_unit)2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID1335787Cell cycle arrest in human STO cells assessed as accumulation at G2/M phase at antiproliferative IC50 after 48 to 72 hrs by propidium iodide staining based flow cytometry2016European journal of medicinal chemistry, Nov-29, Volume: 124[1,2]Oxazolo[5,4-e]isoindoles as promising tubulin polymerization inhibitors.
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1732208Cytotoxicity against human NCI-H1299 cells assessed as reduction in cell viability incubated for 72 hrs by MTS assay2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID1201341Inhibition of tubulin polymerization in human U2OS cells at cytotoxic IC50 level after 72 hrs by Western blotting method2015European journal of medicinal chemistry, Apr-13, Volume: 94Water-soluble isoindolo[2,1-a]quinoxalin-6-imines: in vitro antiproliferative activity and molecular mechanism(s) of action.
AID762136Cytotoxicity against human U87MG cells after 72 hrs by resazurin assay2013Journal of medicinal chemistry, Aug-08, Volume: 56, Issue:15
Synthesis and biological evaluation of a new series of highly functionalized 7'-homo-anhydrovinblastine derivatives.
AID642061Growth inhibition of human OVCAR8 cells overexpressing P-glycoprotein after 96 hrs2011Journal of medicinal chemistry, Dec-22, Volume: 54, Issue:24
Design and synthesis of 2-heterocyclyl-3-arylthio-1H-indoles as potent tubulin polymerization and cell growth inhibitors with improved metabolic stability.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1692307Induction of cell cycle arrest in human NCI-H1975 cells assessed as increase in G2/M phase accumulation at 100 nM incubated for 24 hrs by propidium iodide staining based flow cytometry analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID392701Antitumor activity against mouse P388 cells xenografted in mouse assessed as median life span at 6 mg/kg, ip q4d for 3 days measured for 60 days2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis and SAR of vinca alkaloid analogues.
AID1221965Transporter substrate index of efflux ratio in human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1692354Inhibition of epithelial-mesenchymal transition in human HCT-116 cells assessed as downregulation of MMP-9 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID540224Clearance in dog after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID412799Cytotoxicity against human KB cells after 72 hrs2009Journal of medicinal chemistry, Jan-08, Volume: 52, Issue:1
Synthesis and biological evaluation of vinca alkaloids and phomopsin hybrids.
AID1692310Induction of cell cycle arrest in human NCI-H1975 cells assessed as decrease in cyclin B1 level at 1 to 100 nM incubated for 24 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692323Induction of apoptosis in human HCT-116 cells assessed as decrease in Bcl-2 expression at 0.01 to 1 uM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1732214Induction of cell cycle arrest in human MES-SA cells assessed as G1 phase incubated for 72 hrs by PI staining based flow cytometry analysis (Rvb = 0.9 %)2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID488588Cytotoxicity against human SMMC7721 cells after 48 hrs by MTT assay2010Journal of natural products, Jun-25, Volume: 73, Issue:6
Cytotoxic indole alkaloids from Melodinus tenuicaudatus.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1692327Antimigratory activity against human NCI-H1975 cells assessed as reduction in migration at 5 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID409953Inhibition of mouse liver MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID719381Toxicity in BALB/cA nude mouse xenografted with human A549 cells assessed as change in body weight at 9 mg/kg, iv tid for 7 days (Rvb = 27.61 g)2012Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24
Synthesis and structure-activity relationship studies of cytotoxic vinorelbine amide analogues.
AID392698Cytotoxicity against human MCF7 cells2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis and SAR of vinca alkaloid analogues.
AID289021Antitumor activity in nude BALB/c mouse bearing A549 cell xenografts assessed as relative tumor volume at 10 mg/kg, iv2007Bioorganic & medicinal chemistry, Aug-01, Volume: 15, Issue:15
Synthesis and structure-activity relationships study of novel anti-tumor carbamate anhydrovinblastine analogues.
AID1692343Inhibition of epithelial-mesenchymal transition in human HepG2 cells assessed as decrease in N-cadherin expression at 0.1 to 10 uM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1195238Antiproliferative activity against exponentially growing adherent human SCC114 cells assessed as inhibition of cell proliferation after 72 hrs by luminescence detection based ATPlite assay2015Bioorganic & medicinal chemistry letters, , Volume: 25, Issue:10
Synthesis and activities towards resistant cancer cells of sulfone and sulfoxide griseofulvin derivatives.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1154393Inhibition of sheep brain tubulin assembly by UV-spectrophotometry2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
One-pot synthesis of vinca alkaloids-phomopsin hybrids.
AID1221957Apparent permeability from basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1692352Inhibition of epithelial-mesenchymal transition in human HepG2 cells assessed as downregulation of Snail-1 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID705139Cytotoxicity against human HeLa cells by MTT assay2012Bioorganic & medicinal chemistry letters, Jan-01, Volume: 22, Issue:1
Ceric ammonium nitrate-promoted oxidative coupling reaction for the synthesis and evaluation of a series of anti-tumor amide anhydrovinblastine analogs.
AID1692308Induction of cell cycle arrest in human HepG2 cells assessed as increase in G2/M phase accumulation at 0.1 to 10 uM incubated for 24 hrs by propidium iodide staining based flow cytometry analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1194490Cytotoxicity against human HCT116 cells assessed as inhibition of cell proliferation after 72 hrs2015Bioorganic & medicinal chemistry letters, Apr-15, Volume: 25, Issue:8
Synthesis and biological evaluation of C-13' substituted 7'-homo-anhydrovinblastine derivatives.
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1692341Inhibition of epithelial-mesenchymal transition in human HepG2 cells assessed as decrease in E-cadherin expression at 0.1 to 10 uM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1628800Cell cycle arrest in human STO cells assessed as mitotic cells at 2 nM after 72 hrs by MPM2 staining-based fluorescence microscopic analysis relative to control2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1692331Antimigratory activity against human HepG2 cells assessed as reduction in migration at 10 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1732211Cytotoxicity against human MES-SA/Dx5 cells assessed as reduction in cell viability incubated for 72 hrs by MTS assay2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID1692353Inhibition of epithelial-mesenchymal transition in human HCT-116 cells assessed as downregulation of MMP-2 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID721877Cytotoxicity against human NCI/ADR-RES cells assessed as growth inhibition by trypan blue exclusion assay2013Journal of medicinal chemistry, Jan-10, Volume: 56, Issue:1
Toward highly potent cancer agents by modulating the C-2 group of the arylthioindole class of tubulin polymerization inhibitors.
AID1692305Induction of cell cycle arrest in human NCI-H1975 cells assessed as increase in G2/M phase accumulation at 1 nM incubated for 24 hrs by propidium iodide staining based flow cytometry analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1239200Inhibition of brain tubulin (unknown origin) polymerization measured up to 15 to 30 mins2015Journal of medicinal chemistry, Aug-27, Volume: 58, Issue:16
Scaffold Diversity Inspired by the Natural Product Evodiamine: Discovery of Highly Potent and Multitargeting Antitumor Agents.
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID540225Volume of distribution at steady state in dog after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID725341Cell cycle arrest in human HT-29 cells assessed as accumulation at sub-G1 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1692312Induction of cell cycle arrest in human HCT-116 cells assessed as decrease in cyclin B1 level at 0.01 to 1 uM incubated for 24 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID762135Cytotoxicity against HUVEC after 72 hrs by resazurin assay2013Journal of medicinal chemistry, Aug-08, Volume: 56, Issue:15
Synthesis and biological evaluation of a new series of highly functionalized 7'-homo-anhydrovinblastine derivatives.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID721875Cytotoxicity against human MESSA cells assessed as growth inhibition after 72 hrs by Celltiter-Glo luminescent assay2013Journal of medicinal chemistry, Jan-10, Volume: 56, Issue:1
Toward highly potent cancer agents by modulating the C-2 group of the arylthioindole class of tubulin polymerization inhibitors.
AID1692334Antimigratory activity against human HCT-116 cells assessed as reduction in migration at 10 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID1424793Growth inhibition of human NCI/ADR-RES cells after 96 hrs by trypan blue exclusion assay2018European journal of medicinal chemistry, May-25, Volume: 152New 6- and 7-heterocyclyl-1H-indole derivatives as potent tubulin assembly and cancer cell growth inhibitors.
AID1628794Cell cycle arrest in human STO cells assessed as accumulation at G2/M phase at IC50 after 48 to 72 hrs by propidium iodide staining-based flow cytometric method2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1692329Antimigratory activity against human HepG2 cells assessed as reduction in migration at 0.1 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1322434Inhibition of P-gp in doxorubicin-resistant human K562R cells assessed as rhodamine influx by measuring mean fluorescence intensity at 10 uM incubated for 20 mins by flow cytometry (Rvb = 1.8 No_unit)2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1692338Inhibition of epithelial-mesenchymal transition in human NCI-H1975 cells assessed as increase in E-cadherin expression at 1 to 100 nM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692350Inhibition of epithelial-mesenchymal transition in human HepG2 cells assessed as downregulation of MMP-2 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1628797Cell cycle arrest in human MP4 cells assessed as decrease in cell levels at S phase at IC50 after 48 to 72 hrs by propidium iodide staining-based flow cytometric method2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1628784Inhibition of tubulin polymerization in human MP4 cells at 10 nM after 24 hrs by Western blot analysis relative to soluble fraction of tubulin2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1732207Cytotoxicity against human NCI-H661 cells assessed as reduction in cell viability incubated for 72 hrs by MTS assay2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID540228Clearance in human after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID719382Toxicity in BALB/cA nude mouse xenografted with human A549 cells assessed as mortality at 9 mg/kg, iv tid for 7 days2012Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24
Synthesis and structure-activity relationship studies of cytotoxic vinorelbine amide analogues.
AID596141Antiproliferative activity against human HT-29 cells after 72 hrs by sulforhodamine B assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Synthesis and biological evaluation of 2,4,5-substituted pyrimidines as a new class of tubulin polymerization inhibitors.
AID624626Ratio of apparent permeability from basolateral to apical side over apical to basolateral side determined in MDR1-MDCKII cells2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID697852Inhibition of electric eel AChE at 2 mg/ml by Ellman's method2012Bioorganic & medicinal chemistry, Nov-15, Volume: 20, Issue:22
Exploration of natural compounds as sources of new bifunctional scaffolds targeting cholinesterases and beta amyloid aggregation: the case of chelerythrine.
AID409955Inhibition of mouse liver MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID719383Antitumor activity against human A549 cells xenografted in BALB/cA nude mouse assessed as growth inhibition at 9 mg/kg, iv tid for 7 days relative to control2012Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24
Synthesis and structure-activity relationship studies of cytotoxic vinorelbine amide analogues.
AID1335778Inhibition of alpha-tubulin polymerization in human human MP8 cells assessed as increase in ratio of soluble to polymerized tubulin fraction at 13 nM after 24 hrs by western blot analysis2016European journal of medicinal chemistry, Nov-29, Volume: 124[1,2]Oxazolo[5,4-e]isoindoles as promising tubulin polymerization inhibitors.
AID289013Cytotoxicity against human HeLa cells after 72 hrs by SRB assay2007Bioorganic & medicinal chemistry, Aug-01, Volume: 15, Issue:15
Synthesis and structure-activity relationships study of novel anti-tumor carbamate anhydrovinblastine analogues.
AID624629Inhibition of Pgp expressed in MDR1-MDCKII cells measured by calcein-AM assay2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID1692313Induction of apoptosis in human NCI-H1975 cells assessed as increase in early apoptotic cells at 1 to 100 nM incubated for 48 hrs by annexin V-FITC and PI staining based flow cytometry analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1639167Antiproliferative activity against human Hep293TT cells assessed as growth inhibition after 48 hrs by sulforhodamine B assay2019Journal of natural products, 04-26, Volume: 82, Issue:4
Anacolosins A-F and Corymbulosins X and Y, Clerodane Diterpenes from Anacolosa clarkii Exhibiting Cytotoxicity toward Pediatric Cancer Cell Lines.
AID1224383Cytotoxicity against human K562 cells after 72 hrs by resazurin-based fluorimetric assay2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Endiandric acid analogues from Beilschmiedia ferruginea as dual inhibitors of Bcl-xL/Bak and Mcl-1/Bid interactions.
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1154396Antiproliferative activity against human K562 cells after 72 hrs2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
One-pot synthesis of vinca alkaloids-phomopsin hybrids.
AID1692314Induction of apoptosis in human NCI-H1975 cells assessed as increase in late apoptotic cells at 1 to 100 nM incubated for 48 hrs by annexin V-FITC and PI staining based flow cytometry analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1732218Cytotoxicity against human MES-SA/Dx5 cells assessed as cell viability at 16 uM incubated for 72 hrs by MTS assay relative to control2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID1221963Transporter substrate index ratio of permeability from apical to basolateral side in human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1195236Antiproliferative activity against exponentially growing adherent human HCC1937 cells assessed as inhibition of cell proliferation after 72 hrs by luminescence detection based ATPlite assay2015Bioorganic & medicinal chemistry letters, , Volume: 25, Issue:10
Synthesis and activities towards resistant cancer cells of sulfone and sulfoxide griseofulvin derivatives.
AID725338Cell cycle arrest in human HT-29 cells assessed as accumulation at G1 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID624628Drug-stimulated Pgp ATPase activity ratio determined in MDR1-Sf9 cell membranes with test compound at a concentration of 20uM2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID365321Cytotoxicity against human A549 cells after 72 hrs by SRB assay2008Journal of natural products, Oct, Volume: 71, Issue:10
Synthesis and structure-activity relationship studies of cytotoxic ester and ether anhydrovinblastine derivatives.
AID1255691Cytotoxicity against human HL60 cells after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
New SIRT1 activator from alkaline hydrolysate of total saponins in the stems-leaves of Panax ginseng.
AID1692349Inhibition of epithelial-mesenchymal transition in human NCI-H1975 cells assessed as downregulation of Snail-1 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1424792Growth inhibition of human OVCAR8 cells after 96 hrs by trypan blue exclusion assay2018European journal of medicinal chemistry, May-25, Volume: 152New 6- and 7-heterocyclyl-1H-indole derivatives as potent tubulin assembly and cancer cell growth inhibitors.
AID1692332Antimigratory activity against human HCT-116 cells assessed as reduction in migration at 1 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID596137Displacement of colchicine from pig brain tubulin at 25 uM after 60 mins by fluorescence assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Synthesis and biological evaluation of 2,4,5-substituted pyrimidines as a new class of tubulin polymerization inhibitors.
AID697853Inhibition of horse BChE at 2 mg/ml by Ellman's method2012Bioorganic & medicinal chemistry, Nov-15, Volume: 20, Issue:22
Exploration of natural compounds as sources of new bifunctional scaffolds targeting cholinesterases and beta amyloid aggregation: the case of chelerythrine.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID762137Cytotoxicity against human K562 cells after 72 hrs by resazurin assay2013Journal of medicinal chemistry, Aug-08, Volume: 56, Issue:15
Synthesis and biological evaluation of a new series of highly functionalized 7'-homo-anhydrovinblastine derivatives.
AID547804Selectivity window, ratio of EC50 for BESM cells to EC50 for Trypanosoma cruzi amastigotes infected in BESM cells2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Image-based high-throughput drug screening targeting the intracellular stage of Trypanosoma cruzi, the agent of Chagas' disease.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1732209Cytotoxicity against human A549 cells assessed as reduction in cell viability incubated for 72 hrs by MTS assay2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID681132TP_TRANSPORTER: ATP hydrolysis in MDR1-expressing Sf9 cells2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID1692335Antiinvasive activity against human NCI-H1975 cells assessed as reduction in invasion at 1 to 10 nM measured after 48 hrs by DAPI staining based transwell assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID725096Cell cycle arrest in human HL60 cells assessed as accumulation at G2 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID547621Cytotoxicity against BESM cells after 88 hrs by HTS assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Image-based high-throughput drug screening targeting the intracellular stage of Trypanosoma cruzi, the agent of Chagas' disease.
AID1732216Induction of cell cycle arrest in human MES-SA/Dx5 cells assessed as G1 phase at 16 uM incubated for 72 hrs by PI staining based flow cytometry analysis (Rvb = 0.3 to 0.4 %)2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID1639166Antiproliferative activity against human D283 cells assessed as growth inhibition after 48 hrs by sulforhodamine B assay2019Journal of natural products, 04-26, Volume: 82, Issue:4
Anacolosins A-F and Corymbulosins X and Y, Clerodane Diterpenes from Anacolosa clarkii Exhibiting Cytotoxicity toward Pediatric Cancer Cell Lines.
AID596142Antiproliferative activity against human NCI-H460 cells after 72 hrs by sulforhodamine B assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Synthesis and biological evaluation of 2,4,5-substituted pyrimidines as a new class of tubulin polymerization inhibitors.
AID1221962Efflux ratio of permeability from apical to basolateral side over basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID392706Toxicity to mouse assessed as mortality at 12 mg/kg, ip q4d for 3 days2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis and SAR of vinca alkaloid analogues.
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1154394Antiproliferative activity against human HCT116 cells after 72 hrs2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
One-pot synthesis of vinca alkaloids-phomopsin hybrids.
AID725337Cell cycle arrest in human HL60 cells assessed as accumulation at G1 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID408415Inhibition of pig brain tubulin polymerization assessed as ratio of unpolymerized to polymerized tubulin at 10 uM2008Bioorganic & medicinal chemistry, Jun-01, Volume: 16, Issue:11
Inhibitors of tubulin polymerization: synthesis and biological evaluation of hybrids of vindoline, anhydrovinblastine and vinorelbine with thiocolchicine, podophyllotoxin and baccatin III.
AID1195237Antiproliferative activity against exponentially growing adherent human HCC1937 cells assessed as inhibition of cell proliferation at 10 uM after 72 hrs by luminescence detection based ATPlite assay2015Bioorganic & medicinal chemistry letters, , Volume: 25, Issue:10
Synthesis and activities towards resistant cancer cells of sulfone and sulfoxide griseofulvin derivatives.
AID540223Volume of distribution at steady state in rat after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID1692302Inhibition of colony formation in human NCI-H1975 cells at 1 to 100 nM incubated for 3 to 4 days by crystal violet staining based assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID725336Cell cycle arrest in human CAL33 cells assessed as accumulation at S phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID547622Antitrypanosomal activity against Trypanosoma cruzi amastigotes infected in BESM cells measured after 88 hrs postinfection by HTS assay2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Image-based high-throughput drug screening targeting the intracellular stage of Trypanosoma cruzi, the agent of Chagas' disease.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID1194489Cytotoxicity against human K562 cells assessed as inhibition of cell proliferation after 72 hrs2015Bioorganic & medicinal chemistry letters, Apr-15, Volume: 25, Issue:8
Synthesis and biological evaluation of C-13' substituted 7'-homo-anhydrovinblastine derivatives.
AID1201340Induction of apoptosis in human U2OS cells assessed as increase in caspase-3 catalytic activity at cytotoxic IC50 level after 72 hrs2015European journal of medicinal chemistry, Apr-13, Volume: 94Water-soluble isoindolo[2,1-a]quinoxalin-6-imines: in vitro antiproliferative activity and molecular mechanism(s) of action.
AID725097Cell cycle arrest in human HT-29 cells assessed as accumulation at G2 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID1692296Cytotoxicity against human NCI-H1975 cells assessed as reduction in cell viability incubated for 48 hrs by MTT assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID725099Cell cycle arrest in human HL60 cells assessed as accumulation at S phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID1628795Cell cycle arrest in human MP4 cells assessed as decrease in cell levels at G1 phase at IC50 after 48 to 72 hrs by propidium iodide staining-based flow cytometric method2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1692321Induction of apoptosis in human HepG2 cells assessed as decrease in Bcl-xl expression at 0.1 to 10 uM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1732215Induction of cell cycle arrest in human MES-SA/Dx5 cells assessed as G1 phase at 8 uM incubated for 72 hrs by PI staining based flow cytometry analysis (Rvb = 0.3 to 0.4 %)2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1639165Antiproliferative activity against human SJCRH30 cells assessed as growth inhibition after 48 hrs by sulforhodamine B assay2019Journal of natural products, 04-26, Volume: 82, Issue:4
Anacolosins A-F and Corymbulosins X and Y, Clerodane Diterpenes from Anacolosa clarkii Exhibiting Cytotoxicity toward Pediatric Cancer Cell Lines.
AID1692319Induction of apoptosis in human NCI-H1975 cells assessed as increase in Bax expression at 1 to 100 nM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1692328Antimigratory activity against human NCI-H1975 cells assessed as reduction in migration at 10 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1335790Cell cycle arrest in human MP8 cells assessed as mitotic cells at antiproliferative IC50 after 72 hrs by fluorescence microscopic analysis relative to control2016European journal of medicinal chemistry, Nov-29, Volume: 124[1,2]Oxazolo[5,4-e]isoindoles as promising tubulin polymerization inhibitors.
AID1692336Antiinvasive activity against human HepG2 cells assessed as reduction in invasion at 0.1 to 10 nM measured after 48 hrs by DAPI staining based transwell assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1628783Inhibition of tubulin polymerization in human STO cells at 2 nM after 24 hrs by Western blot analysis relative to soluble fraction of tubulin2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1480298Inhibition of Ebolavirus glycoprotein/matrix protein VP40 entry in human HeLa cells after 4.5 hrs beta-lactamase reporter assay2018Journal of medicinal chemistry, 04-26, Volume: 61, Issue:8
Computer-Aided Discovery and Characterization of Novel Ebola Virus Inhibitors.
AID1692348Inhibition of epithelial-mesenchymal transition in human NCI-H1975 cells assessed as downregulation of MMP-9 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID596144Cell cycle arrest in human KB cells assessed as accumulation of cells at G2/M phase after 24 hrs by propidium iodide-based FACScan2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Synthesis and biological evaluation of 2,4,5-substituted pyrimidines as a new class of tubulin polymerization inhibitors.
AID1692320Induction of apoptosis in human HepG2 cells assessed as decrease in Bcl-2 expression at 0.1 to 10 uM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID392699Cytotoxicity against human HeLa cells2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis and SAR of vinca alkaloid analogues.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1692345Inhibition of epithelial-mesenchymal transition in human HCT-116 cells assessed as decrease in Vimentin expression at 0.01 to 1 uM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1237724Cytotoxicity against Pgp overexpressing human NCI-ADR-RES cells assessed as growth inhibition after 48 hrs by SRB assay2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
New Indole Tubulin Assembly Inhibitors Cause Stable Arrest of Mitotic Progression, Enhanced Stimulation of Natural Killer Cell Cytotoxic Activity, and Repression of Hedgehog-Dependent Cancer.
AID1628770Cell cycle arrest in human STO cells assessed as decrease in cell levels at G1 phase at IC50 after 48 to 72 hrs by propidium iodide staining-based flow cytometric method2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1692301Cytotoxicity against human HCT-116 cells assessed as effect on cell morphology incubated for 48 hrs by DAPI staining based fluorescence microscopy2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692297Cytotoxicity against human HepG2 cells assessed as reduction in cell viability incubated for 48 hrs by MTT assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692326Antimigratory activity against human NCI-H1975 cells assessed as reduction in migration at 1 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID721876Cytotoxicity against human OVCAR8 cells assessed as growth inhibition by trypan blue exclusion assay2013Journal of medicinal chemistry, Jan-10, Volume: 56, Issue:1
Toward highly potent cancer agents by modulating the C-2 group of the arylthioindole class of tubulin polymerization inhibitors.
AID540222Clearance in rat after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID1221960Apparent permeability from apical to basolateral side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID596143Antiproliferative activity against human A549 cells after 72 hrs by sulforhodamine B assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Synthesis and biological evaluation of 2,4,5-substituted pyrimidines as a new class of tubulin polymerization inhibitors.
AID1732213Cytotoxicity against human MES-SA cells assessed as cell viability at 2 uM incubated for 72 hrs by MTS assay relative to control2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID1255692Cytotoxicity against human HepG2 cells after 48 hrs by MTT assay2015Bioorganic & medicinal chemistry letters, Nov-15, Volume: 25, Issue:22
New SIRT1 activator from alkaline hydrolysate of total saponins in the stems-leaves of Panax ginseng.
AID289017Effect on Body weight in nude BALB/c mouse bearing A549 cell xenografts at 10 mg/kg, iv2007Bioorganic & medicinal chemistry, Aug-01, Volume: 15, Issue:15
Synthesis and structure-activity relationships study of novel anti-tumor carbamate anhydrovinblastine analogues.
AID1335789Cell cycle arrest in human STO cells assessed as mitotic cells at antiproliferative IC50 after 72 hrs by fluorescence microscopic analysis relative to control2016European journal of medicinal chemistry, Nov-29, Volume: 124[1,2]Oxazolo[5,4-e]isoindoles as promising tubulin polymerization inhibitors.
AID1692318Induction of apoptosis in human NCI-H1975 cells assessed as decrease in Bcl-xl expression at 1 to 100 nM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID488591Cytotoxicity against human SW480 cells after 48 hrs by MTT assay2010Journal of natural products, Jun-25, Volume: 73, Issue:6
Cytotoxic indole alkaloids from Melodinus tenuicaudatus.
AID723114Cytotoxicity against mouse L1210 cells assessed as growth inhibition after 72 hrs by phosphatase assay2013Journal of medicinal chemistry, Jan-24, Volume: 56, Issue:2
Total synthesis and evaluation of vinblastine analogues containing systematic deep-seated modifications in the vindoline subunit ring system: core redesign.
AID1692315Induction of apoptosis in human HepG2 cells assessed as increase in late apoptotic cells at 0.1 to 10 uM incubated for 48 hrs by annexin V-FITC and PI staining based flow cytometry analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1194487Inhibition of tubulin (unknown origin) polymerization2015Bioorganic & medicinal chemistry letters, Apr-15, Volume: 25, Issue:8
Synthesis and biological evaluation of C-13' substituted 7'-homo-anhydrovinblastine derivatives.
AID1322431Cytotoxicity against human K562 cells incubated for 72 hrs by CellTiter 96 aqueous one solution reagent based assay2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID1692333Antimigratory activity against human HCT-116 cells assessed as reduction in migration at 5 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID681130TP_TRANSPORTER: transepithelial transport (basal to apical) in MDR1-expressing MDCKII cells2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1692304Inhibition of colony formation in human HCT-116 cells at 0.01 to 1 uM incubated for 3 to 4 days by crystal violet staining based assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID392700Antitumor activity against mouse P388 cells xenografted in mouse assessed as median life span at 12 mg/kg, ip q4d for 3 days measured for 60 days2009Bioorganic & medicinal chemistry letters, Feb-15, Volume: 19, Issue:4
Synthesis and SAR of vinca alkaloid analogues.
AID1639164Antiproliferative activity against human A673 cells assessed as growth inhibition after 48 hrs by sulforhodamine B assay2019Journal of natural products, 04-26, Volume: 82, Issue:4
Anacolosins A-F and Corymbulosins X and Y, Clerodane Diterpenes from Anacolosa clarkii Exhibiting Cytotoxicity toward Pediatric Cancer Cell Lines.
AID723115Cytotoxicity against human HCT116 cells assessed as growth inhibition after 72 hrs by phosphatase assay2013Journal of medicinal chemistry, Jan-24, Volume: 56, Issue:2
Total synthesis and evaluation of vinblastine analogues containing systematic deep-seated modifications in the vindoline subunit ring system: core redesign.
AID1692306Induction of cell cycle arrest in human NCI-H1975 cells assessed as increase in G2/M phase accumulation at 10 nM incubated for 24 hrs by propidium iodide staining based flow cytometry analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID762138Cytotoxicity against human HCT116 cells after 72 hrs by resazurin assay2013Journal of medicinal chemistry, Aug-08, Volume: 56, Issue:15
Synthesis and biological evaluation of a new series of highly functionalized 7'-homo-anhydrovinblastine derivatives.
AID1692311Induction of cell cycle arrest in human HepG2 cells assessed as decrease in cyclin B1 level at 0.1 to 10 uM incubated for 24 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1183715Cytotoxicity against human OVCAR8 cells assessed as growth inhibition after 96 hrs by Giemsa staining-based light microscopy2014Journal of medicinal chemistry, Aug-14, Volume: 57, Issue:15
New pyrrole derivatives with potent tubulin polymerization inhibiting activity as anticancer agents including hedgehog-dependent cancer.
AID1692300Cytotoxicity against human HepG2 cells assessed as effect on cell morphology incubated for 48 hrs by DAPI staining based fluorescence microscopy2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID624622Apparent permeability (Papp) from apical to basolateral side determined in MDR1-MDCKII cells2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID725342Cell cycle arrest in human CAL33 cells assessed as accumulation at sub-G1 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID681121TP_TRANSPORTER: inhibition of Calcein-AM efflux in MDR1-expressing MDCKII cells2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID596140Antiproliferative activity against human SKOV3 cells after 72 hrs by sulforhodamine B assay2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Synthesis and biological evaluation of 2,4,5-substituted pyrimidines as a new class of tubulin polymerization inhibitors.
AID1692347Inhibition of epithelial-mesenchymal transition in human NCI-H1975 cells assessed as downregulation of MMP-2 by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID725340Cell cycle arrest in human HL60 cells assessed as accumulation at sub-G1 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID1692342Inhibition of epithelial-mesenchymal transition in human HepG2 cells assessed as decrease in Vimentin expression at 0.1 to 10 uM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692325Induction of apoptosis in human HCT-116 cells assessed as increase in Bax expression at 0.01 to 1 uM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID659198Cytotoxicity against human A549 cells by MTT assay2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
The effect of vindoline C-16 substituents on the biomimetic coupling reaction: synthesis and cytotoxicity evaluation of the corresponding vinorelbine analogues.
AID1692322Induction of apoptosis in human HepG2 cells assessed as increase in Bax expression at 0.1 to 10 uM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1221982Fraction absorbed in human2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1194491Cytotoxicity against human U87 cells assessed as inhibition of cell proliferation after 72 hrs2015Bioorganic & medicinal chemistry letters, Apr-15, Volume: 25, Issue:8
Synthesis and biological evaluation of C-13' substituted 7'-homo-anhydrovinblastine derivatives.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID540226Clearance in monkey after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID1221961Apparent permeability from basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1692324Induction of apoptosis in human HCT-116 cells assessed as decrease in Bcl-xl expression at 0.01 to 1 uM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID540227Volume of distribution at steady state in monkey after iv administration2006Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 34, Issue:7
Extrapolation of preclinical pharmacokinetics and molecular feature analysis of "discovery-like" molecules to predict human pharmacokinetics.
AID1692316Induction of apoptosis in human HCT-116 cells assessed as increase in late apoptotic cells at 0.01 to 1 uM incubated for 48 hrs by annexin V-FITC and PI staining based flow cytometry analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1322437Inhibition of P-gp in doxorubicin-resistant human K562R cells assessed as rhodamine efflux by measuring ratio of mean fluorescence intensity in presence and absence of compound at 10 uM incubated for 1 hr by flow cytometry2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID723113Cytotoxicity against human vinblastine-resistant HCT116/VM46 cells assessed as growth inhibition after 72 hrs by phosphatase assay2013Journal of medicinal chemistry, Jan-24, Volume: 56, Issue:2
Total synthesis and evaluation of vinblastine analogues containing systematic deep-seated modifications in the vindoline subunit ring system: core redesign.
AID1154395Antiproliferative activity against human U87 cells after 72 hrs2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
One-pot synthesis of vinca alkaloids-phomopsin hybrids.
AID488590Cytotoxicity against human MCF7 cells after 48 hrs by MTT assay2010Journal of natural products, Jun-25, Volume: 73, Issue:6
Cytotoxic indole alkaloids from Melodinus tenuicaudatus.
AID1692317Induction of apoptosis in human NCI-H1975 cells assessed as decrease in Bcl-2 expression at 1 to 100 nM incubated for 48 hrs by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692344Inhibition of epithelial-mesenchymal transition in human HCT-116 cells assessed as increase in E-cadherin expression at 0.01 to 1 uM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1335777Inhibition of alpha-tubulin polymerization in human human STO cells assessed as increase in ratio of soluble to polymerized tubulin fraction at 2 nM after 24 hrs by western blot analysis2016European journal of medicinal chemistry, Nov-29, Volume: 124[1,2]Oxazolo[5,4-e]isoindoles as promising tubulin polymerization inhibitors.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID477295Octanol-water partition coefficient, log P of the compound2010European journal of medicinal chemistry, Apr, Volume: 45, Issue:4
QSPR modeling of octanol/water partition coefficient of antineoplastic agents by balance of correlations.
AID725339Cell cycle arrest in human CAL33 cells assessed as accumulation at G1 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID1224382Cytotoxicity against human HCT116 cells after 72 hrs by resazurin-based fluorimetric assay2014Journal of natural products, Jun-27, Volume: 77, Issue:6
Endiandric acid analogues from Beilschmiedia ferruginea as dual inhibitors of Bcl-xL/Bak and Mcl-1/Bid interactions.
AID430359Antitumor activity against mouse S180 cells xenografted in Kunming mouse at 10 mg/kg, iv administered on day 1 and 42009Journal of natural products, Jun, Volume: 72, Issue:6
Synthesis and structure-activity relationship studies of cytotoxic anhydrovinblastine amide derivatives.
AID1322447Cytotoxicity against human MRC5 cells cells incubated for 72 hrs by CellTiter 96 aqueous one solution reagent based assay2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID488587Cytotoxicity against human HL60 cells after 48 hrs by MTT assay2010Journal of natural products, Jun-25, Volume: 73, Issue:6
Cytotoxic indole alkaloids from Melodinus tenuicaudatus.
AID1628801Cell cycle arrest in human MP8 cells assessed as mitotic cells at 13 nM after 72 hrs by MPM2 staining-based fluorescence microscopic analysis relative to control2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID762140Inhibition of sheep brain tubulin polymerization by UV spectrophotometric analysis2013Journal of medicinal chemistry, Aug-08, Volume: 56, Issue:15
Synthesis and biological evaluation of a new series of highly functionalized 7'-homo-anhydrovinblastine derivatives.
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID430358Cytotoxicity against human HeLa cells by sulforhodamine B assay2009Journal of natural products, Jun, Volume: 72, Issue:6
Synthesis and structure-activity relationship studies of cytotoxic anhydrovinblastine amide derivatives.
AID409954Inhibition of mouse brain MAOA2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID624623Apparent permeability (Papp) from basolateral to apical side determined in MDR1-MDCKII cells2001The Journal of pharmacology and experimental therapeutics, Nov, Volume: 299, Issue:2
Rational use of in vitro P-glycoprotein assays in drug discovery.
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1692303Inhibition of colony formation in human HepG2 cells at 0.1 to 10 uM incubated for 3 to 4 days by crystal violet staining based assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID725098Cell cycle arrest in human CAL33 cells assessed as accumulation at G2 phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID721873Cytotoxicity against human MESSA/DX5 cells assessed as growth inhibition after 72 hrs by Celltiter-Glo luminescent assay2013Journal of medicinal chemistry, Jan-10, Volume: 56, Issue:1
Toward highly potent cancer agents by modulating the C-2 group of the arylthioindole class of tubulin polymerization inhibitors.
AID1183716Cytotoxicity against human NCI/ADR-RES cells assessed as growth inhibition after 96 hrs by Giemsa staining-based light microscopy2014Journal of medicinal chemistry, Aug-14, Volume: 57, Issue:15
New pyrrole derivatives with potent tubulin polymerization inhibiting activity as anticancer agents including hedgehog-dependent cancer.
AID1692298Cytotoxicity against human HCT-116 cells assessed as reduction in cell viability incubated for 48 hrs by MTT assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID289012Cytotoxicity against human A549 cells after 72 hrs by SRB assay2007Bioorganic & medicinal chemistry, Aug-01, Volume: 15, Issue:15
Synthesis and structure-activity relationships study of novel anti-tumor carbamate anhydrovinblastine analogues.
AID430361Toxicity against mouse S180 cells xenografted in Kunming mouse at 10 mg/kg, iv administered on day 1 and 42009Journal of natural products, Jun, Volume: 72, Issue:6
Synthesis and structure-activity relationship studies of cytotoxic anhydrovinblastine amide derivatives.
AID1692309Induction of cell cycle arrest in human HCT-116 cells assessed as increase in G2/M phase accumulation at 0.01 to 1 uM incubated for 24 hrs by propidium iodide staining based flow cytometry analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692330Antimigratory activity against human HepG2 cells assessed as reduction in migration at 1 nM measured after 96 hrs by scratch wound healing based inverted microscopic analysis relative to control2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID409956Inhibition of mouse brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID642062Growth inhibition of doxorubicin-resistant human NCI-ADR-RES cells overexpressing P-glycoprotein after 96 hrs2011Journal of medicinal chemistry, Dec-22, Volume: 54, Issue:24
Design and synthesis of 2-heterocyclyl-3-arylthio-1H-indoles as potent tubulin polymerization and cell growth inhibitors with improved metabolic stability.
AID1335788Cell cycle arrest in human MP8 cells assessed as accumulation at G2/M phase at antiproliferative IC50 after 48 to 72 hrs by propidium iodide staining based flow cytometry2016European journal of medicinal chemistry, Nov-29, Volume: 124[1,2]Oxazolo[5,4-e]isoindoles as promising tubulin polymerization inhibitors.
AID1628782Inhibition of GTP-induced porcine tubulin polymerization at 10 uM measured every minute up to 60 mins relative to control2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID725100Cell cycle arrest in human HT-29 cells assessed as accumulation at S phase at 0.5 uM after 24 hrs flow cytometry2013European journal of medicinal chemistry, Jan, Volume: 59Synthesis, antiproliferative activity and tubulin targeting effect of acridinone and dioxophenothiazine derivatives.
AID1424777Growth inhibition of human MCF7 cells after 96 hrs by trypan blue exclusion assay2018European journal of medicinal chemistry, May-25, Volume: 152New 6- and 7-heterocyclyl-1H-indole derivatives as potent tubulin assembly and cancer cell growth inhibitors.
AID719385Cytotoxicity against human A549 cells after 24 to 72 hrs by MTT assay2012Bioorganic & medicinal chemistry letters, Dec-15, Volume: 22, Issue:24
Synthesis and structure-activity relationship studies of cytotoxic vinorelbine amide analogues.
AID659197Cytotoxicity against human HeLa cells by MTT assay2012Bioorganic & medicinal chemistry letters, May-15, Volume: 22, Issue:10
The effect of vindoline C-16 substituents on the biomimetic coupling reaction: synthesis and cytotoxicity evaluation of the corresponding vinorelbine analogues.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1322433Resistance index, ratio of IC50 for cytotoxicity against doxorubicin-resistant human K562R cells to IC50 for cytotoxicity against human K562 cells2016Journal of medicinal chemistry, 12-08, Volume: 59, Issue:23
Original Vinca Derivatives: From P-Glycoprotein Substrates to P-Glycoprotein Inhibitors.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID289025Antitumor activity in nude BALB/c mouse bearing A549 cell xenografts assessed as tumor growth inhibition at 10 mg/kg, iv after 12 days2007Bioorganic & medicinal chemistry, Aug-01, Volume: 15, Issue:15
Synthesis and structure-activity relationships study of novel anti-tumor carbamate anhydrovinblastine analogues.
AID1732210Cytotoxicity against human MES-SA cells assessed as reduction in cell viability incubated for 72 hrs by MTS assay2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID1221964Transporter substrate index ratio of permeability from basolateral to apical side in human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis in presence of 1 uM of P-gp inhibitor LY3359792011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID1221958Efflux ratio of permeability from apical to basolateral side over basolateral to apical side of human Caco2 cells at 10 uM up to 120 mins by HPLC-MC analysis2011Drug metabolism and disposition: the biological fate of chemicals, Feb, Volume: 39, Issue:2
Attenuation of intestinal absorption by major efflux transporters: quantitative tools and strategies using a Caco-2 model.
AID365322Cytotoxicity against human HeLa cells after 72 hrs by SRB assay2008Journal of natural products, Oct, Volume: 71, Issue:10
Synthesis and structure-activity relationship studies of cytotoxic ester and ether anhydrovinblastine derivatives.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID431421Cytotoxicity against human MCF7 cells after 72 hrs by MTT assay2009Journal of medicinal chemistry, Oct-08, Volume: 52, Issue:19
Indolobenzazepin-7-ones and 6-, 8-, and 9-membered ring derivatives as tubulin polymerization inhibitors: synthesis and structure--activity relationship studies.
AID1692337Antiinvasive activity against human HCT-116 cells assessed as reduction in invasion at 1 to 10 nM measured after 48 hrs by DAPI staining based transwell assay2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1628771Cell cycle arrest in human MP4 cells assessed as accumulation at G2/M phase at IC50 after 48 to 72 hrs by propidium iodide staining-based flow cytometric method2016Journal of medicinal chemistry, Aug-11, Volume: 59, Issue:15
Preclinical Activity of New [1,2]Oxazolo[5,4-e]isoindole Derivatives in Diffuse Malignant Peritoneal Mesothelioma.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID430357Cytotoxicity against human A549 cells by sulforhodamine B assay2009Journal of natural products, Jun, Volume: 72, Issue:6
Synthesis and structure-activity relationship studies of cytotoxic anhydrovinblastine amide derivatives.
AID1692299Cytotoxicity against human NCI-H1975 cells assessed as effect on cell morphology incubated for 48 hrs by DAPI staining based fluorescence microscopy2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1692346Inhibition of epithelial-mesenchymal transition in human HCT-116 cells assessed as decrease in N-cadherin expression at 0.01 to 1 uM by Western blot analysis2020European journal of medicinal chemistry, Aug-15, Volume: 200Anti-tubulin agent vinorelbine inhibits metastasis of cancer cells by regulating epithelial-mesenchymal transition.
AID1154397Antiproliferative activity against human MCF7 cells after 72 hrs2014Journal of medicinal chemistry, Jun-26, Volume: 57, Issue:12
One-pot synthesis of vinca alkaloids-phomopsin hybrids.
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1237723Cytotoxicity against human OVCAR8 cells assessed as growth inhibition after 48 hrs by SRB assay2015Journal of medicinal chemistry, Aug-13, Volume: 58, Issue:15
New Indole Tubulin Assembly Inhibitors Cause Stable Arrest of Mitotic Progression, Enhanced Stimulation of Natural Killer Cell Cytotoxic Activity, and Repression of Hedgehog-Dependent Cancer.
AID1732217Induction of cell cycle arrest in human MES-SA/Dx5 cells assessed as G1 phase at 32 uM incubated for 72 hrs by PI staining based flow cytometry analysis (Rvb = 0.3 to 0.4 %)2021European journal of medicinal chemistry, Apr-05, Volume: 215CAP rigidification of MS-275 and chidamide leads to enhanced antiproliferative effects mediated through HDAC1, 2 and tubulin polymerization inhibition.
AID488589Cytotoxicity against human A549 cells after 48 hrs by MTT assay2010Journal of natural products, Jun-25, Volume: 73, Issue:6
Cytotoxic indole alkaloids from Melodinus tenuicaudatus.
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1347411qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Mechanism Interrogation Plate v5.0 (MIPE) Libary2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (49)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's13 (26.53)29.6817
2010's33 (67.35)24.3611
2020's3 (6.12)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 66.57

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index66.57 (24.57)
Research Supply Index3.93 (2.92)
Research Growth Index4.67 (4.65)
Search Engine Demand Index110.26 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (66.57)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Reviews1 (2.00%)6.00%
Case Studies0 (0.00%)4.05%
Observational0 (0.00%)0.25%
Other49 (98.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (425)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
NMES for Patients With NSCLC Receiving Palliative Chemotherapy. Is Neuromuscular Electrical Stimulation an Acceptable and Feasible Supportive Therapy for Patients With Non-Small Cell Lung Cancer Receiving Palliative Chemotherapy? [NCT01097317]Phase 252 participants (Anticipated)Interventional2009-09-30Recruiting
Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial [NCT00088530]Phase 3140 participants (Actual)Interventional2004-07-31Completed
A Phase II Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients Pretreated With Chemotherapy or Hormonal Treatment in Combination With Lapatinib for Metastatic Disease [NCT01161368]Phase 29 participants (Actual)Interventional2010-09-30Terminated(stopped due to poor recruitment)
A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease [NCT00302003]Phase 3287 participants (Actual)Interventional2006-02-28Completed
Phase III Study to Compare Trastuzumab-biosimilar (Kanjinti®) Plus Pertuzumab Plus Vinorelbine With Trastuzumab-biosimilar (Kanjinti®) Plus Pertuzumab Plus Docetaxel as First-line Treatment for HER2-positive Advanced Breast Cancer [NCT03811418]Phase 30 participants (Actual)Interventional2019-01-31Withdrawn(stopped due to Study approved with treatment regimen based on current guidelines. However, reimbursement of IMP was not feasible.)
Phase 2 Randomized Study of RT and Reirradiation at Relapse vs Multiple Elective RT Courses With Same Concomitant CT for Newly Diagnosed [NCT03620032]Phase 254 participants (Actual)Interventional2015-11-02Active, not recruiting
PD-1 Inhibitor or PD-1 Inhibitor Plus GVD(Gemcitabine, Vinorelbine and Doxorubicin Liposome) Regimen for Relapsed/Refractory Classical Hodgkin Lymphoma (R/R CHL): a Single Arm, Open Label, Phase II Study [NCT04624984]Phase 242 participants (Anticipated)Interventional2021-04-01Recruiting
Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Recurrent or Metastatic Triple-negative Breast Cancer: a Double-blinded Randomized Controlled Clinical Trial [NCT03932526]Phase 2184 participants (Anticipated)Interventional2019-06-24Not yet recruiting
Randomised Phase II Study of the Combination of Oral Vinorelbine With Capecitabine Versus Gemcitabine in Combination With Paclitaxel Versus Gemcitabine in Combination With Docetaxel as First Line Chemotherapy in Patients With Metastatic Breast Cancer [NCT03887130]Phase 2152 participants (Actual)Interventional2006-03-31Completed
Phase I Clinical Trial of Temsirolimus and Vinorelbine in Advanced Solid Tumors. [NCT01155258]Phase 119 participants (Actual)Interventional2010-06-30Completed
A Randomized Phase III Trial Of Paclitaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Versus Topotecan Plus Cisplatin In Stage IVB, Recurrent Or Persistent Carcinoma of the Cervix [NCT00064077]Phase 3513 participants (Actual)Interventional2003-05-31Completed
Docetaxel (NSC-628503) And Vinorelbine (NSC-608210) Plus Filgrastim (NSC-614629) With Weekly Trastuzumab (NSC-688097) For HER-2 Positive, Stage IV Breast Cancer [NCT00041067]Phase 276 participants (Actual)Interventional2002-09-30Completed
Sensitivity Detection and Drug Resistance Mechanism of Breast Cancer Therapeutic Drugs Based on Organ-like Culture [NCT03925233]300 participants (Anticipated)Observational2019-01-02Enrolling by invitation
A Phase II Study of Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Epithelial Ovarian/Fallopian Tube/ Primary Peritoneal Carcinoma. [NCT01196559]Phase 244 participants (Actual)Interventional2011-01-31Completed
Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage â…¡-â…¢A NSCLC, Prospective, Randomized, Multicenter, Phase â…¢ Clinical Trial [NCT03203590]Phase 3590 participants (Anticipated)Interventional2017-09-30Not yet recruiting
A Phase I/II b (Randomized Controlled) Study of Atezolizumab Combined to BEGEV Regimen as First Salvage Treatment in Patients With Relapsed or Refractory Hodgkin's Lymphoma Candidate to Autologous Stem-Cell Transplantation [NCT05300282]Phase 1/Phase 2140 participants (Anticipated)Interventional2022-08-03Recruiting
A Multicentre Randomised Phase III Trial Comparing Pembrolizumab Versus Standard Chemotherapy for Advanced Pre-treated Malignant Pleural Mesothelioma [NCT02991482]Phase 3144 participants (Actual)Interventional2017-09-12Completed
Chemotherapy Plus Pembrolizumab After Progression With Previous PD-1/PD-L1 Inhibitors in Patients With Advanced Non-small Cell Lung Cancer: Placebo-controlled Randomized Phase II Study [NCT03656094]Phase 298 participants (Anticipated)Interventional2018-11-01Recruiting
A Randomised Phase II Trial of Oral Vinorelbine as Second Line Therapy for Patients With Malignant Pleural Mesothelioma [NCT02139904]Phase 2154 participants (Actual)Interventional2016-03-01Completed
A Phase II Trial of Trastuzumab, Neupogen, and Vinorelbine Investigating the Effects on Immune Function and Clinical Outcomes in Patients With Metastatic Breast Cancer Overexpressing Her-2/Neu [NCT00169104]Phase 2/Phase 323 participants (Actual)Interventional2002-07-31Terminated(stopped due to Closed due to achievement of primary study endpoint)
Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease [NCT00388349]Phase 2146 participants (Actual)Interventional2001-09-30Completed
Clinical Study of Recombinant Human Endostatin Combined With NP Chemotherapy in the Treatment of Stage â…¢A Non Small Cell Lung Cancer [NCT02497118]Phase 430 participants (Actual)Interventional2010-08-31Completed
A Randomized, Controlled Phase â…¢ Study of Paclitaxel Polymeric Micelles for Injection Versus Physician's Choice(TPC) in Human Epidermal Growth Factor Receptor 2-negative (HER2-) Metastatic Breast Cancer (MBC) Subjects Who Have Failed at Least Two Previous [NCT06143553]Phase 3168 participants (Anticipated)Interventional2023-10-30Recruiting
"A Randomized Phase III Trial of Trastuzumab + ALpelisib +/- Fulvestrant Versus Trastuzumab + Chemotherapy in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer. ALPHABET Study." [NCT05063786]Phase 3300 participants (Anticipated)Interventional2021-09-14Recruiting
Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study [NCT00431704]Phase 239 participants (Anticipated)Interventional2007-10-31Active, not recruiting
Randomised, Multicenter Phase II Study in Patients With High Risk Breast Cancer With Capecitabine Versus Vinorelbine With Pathologic Residual Tumors After Preoperative Chemotherapy Secondary ID [NCT03703427]Phase 2200 participants (Anticipated)Interventional2018-11-30Not yet recruiting
Phase I Study of ABT-888 in Combination With Cisplatin and Vinorelbine for Patients With Advanced Triple Negative Breast Cancer and/or BRCA-Mutation Associated Breast Cancer [NCT01104259]Phase 150 participants (Actual)Interventional2010-07-31Completed
Sun Yat-sen University Cancer Center [NCT02362958]Phase 2159 participants (Actual)Interventional2015-01-09Completed
Observational Clinical Trial of Adjuvant Chemotherapy for Non-squamous Cell Carcinoma of Non-small Cell Lung Cancer [NCT03656393]Phase 348 participants (Anticipated)Interventional2018-08-31Recruiting
Prospective Randomized Controlled Study of the Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy [NCT03423849]Phase 2/Phase 3200 participants (Anticipated)Interventional2018-02-08Not yet recruiting
An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments [NCT02574455]Phase 3529 participants (Actual)Interventional2017-11-07Completed
A Randomized, Multicenter, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer [NCT02213744]Phase 2/Phase 3113 participants (Actual)Interventional2014-07-31Terminated(stopped due to Felt not to show benefit over control per DMC and confirmed via futility analysis)
BRIDGE Trial: Phase II Trial of durvalumaB and chemotheRapy Induction Followed by Durvalumab and Radiotherapy in larGe volumE Stage III NSCLC [NCT04765709]Phase 210 participants (Actual)Interventional2021-09-24Active, not recruiting
Evolutionary Inspired Therapy for Newly Diagnosed, Metastatic, Fusion Positive Rhabdomyosarcoma [NCT04388839]Phase 228 participants (Anticipated)Interventional2020-09-27Recruiting
A Randomized, Open-Label Phase 1/2 Study Evaluating Ramucirumab in Pediatric Patients and Young Adults With Relapsed, Recurrent, or Refractory Desmoplastic Small Round Cell Tumor [NCT04145349]Phase 1/Phase 234 participants (Anticipated)Interventional2020-01-22Active, not recruiting
A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer [NCT03262935]Phase 3437 participants (Actual)Interventional2017-12-15Completed
the Effectiveness and Safety Study on Apatinib Combined With Vinorelbine Used for Driver Gene Mutation Negative Third-line and Third-line Post Progression Advanced Non-small Cell Lung Cancer [NCT03652857]Phase 230 participants (Actual)Interventional2017-01-01Completed
An Open-label, Phase II Study Evaluating the Efficacy and Safety of Trastuzumab Combined With Oral Chemotherapy in Patients With HER-2 Positive Stage I Breast Cancer [NCT04922008]Phase 2356 participants (Anticipated)Interventional2021-07-01Not yet recruiting
Efficacy and Safety of Metronomic Oral Vinorelbine Plus Anlotinib in HER2-negative Metastatic Breast Cancer Patients [NCT06015126]60 participants (Anticipated)Interventional2022-10-05Recruiting
A Phase II Study of Metronomic Chemotherapy in Elderly Non-fit Patients (>65 Years) With Aggressive B-Cell Lymphomas [NCT03161054]Phase 221 participants (Actual)Interventional2017-09-12Completed
An International, Multicenter, Phase II, Randomized, Parallel-arm Trial Investigating the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After F [NCT03358004]Phase 24 participants (Actual)Interventional2017-06-14Terminated(stopped due to Low accrual rate)
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Early Stage or Locally Advanced Breast Cancer Patients. [NCT03947242]48 participants (Anticipated)Interventional2019-06-01Not yet recruiting
Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study [NCT03933982]Phase 230 participants (Anticipated)Interventional2018-12-22Recruiting
Dose-finding Study of Satraplatin in Combination With Oral Vinorelbine in Patients With Advanced Solid Tumors [NCT01220284]Phase 127 participants (Actual)Interventional2008-02-29Active, not recruiting
A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients. [NCT01126138]Phase 3200 participants (Anticipated)Interventional2010-07-31Recruiting
A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy as First-line Treatment for Women With HER2-positive and p95HER2-positive Metastatic Breast Cancer [NCT01137994]Phase 20 participants (Actual)Interventional2011-10-31Withdrawn
An Open-label Randomized Parallel Two-arm Multicenter Study of Eribulin Versus Vinorelbine in Female Subjects With Locally Recurrent or Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Inclu [NCT02225470]Phase 3530 participants (Actual)Interventional2013-09-26Completed
A Phase I/II Study to Assess the Safety and Therapeutic Effect of INCB007839 in Combination With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer. [NCT01254136]Phase 1/Phase 220 participants (Anticipated)Interventional2010-10-31Terminated(stopped due to Incyte has suspended development of the compound.)
Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma [NCT03618550]Phase 269 participants (Anticipated)Interventional2018-08-01Recruiting
A Multi-center Phase III Randomized Controlled Trial Comparing Between Adjuvant Chemotherapy and Observation in High Risk Patients With Completely Resected Stage Ib Lung Adenocarcinoma [NCT02281708]Phase 31,012 participants (Anticipated)Interventional2014-10-31Recruiting
A Randomized, Controlled, Open-label, Multi-center Phase III Clinical Trial of SKB264 for Injection Versus Investigator Selected Regimens in Patients With Unresectable Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer Who Have Failed [NCT05347134]Phase 3254 participants (Anticipated)Interventional2022-06-10Active, not recruiting
Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) Trial: Adaptive Clinical Treatment (ACT) [NCT05238831]Early Phase 125 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Phase I/II Study of Carboplatin and Navelbine for Advanced Non-Small Cell Lung Cancer [NCT00004096]Phase 1/Phase 20 participants Interventional1999-08-31Completed
Phase II Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer [NCT03939871]Phase 230 participants (Anticipated)Interventional2017-12-12Recruiting
A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance i [NCT04994132]Phase 3118 participants (Anticipated)Interventional2021-09-14Recruiting
A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (≥ 4 cm) - IIIA Non-small Cell Lung Cancer (NSCLC) [NCT00324805]Phase 31,501 participants (Actual)Interventional2007-06-01Active, not recruiting
Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab [NCT01238029]Phase 112 participants (Actual)Interventional2010-10-31Terminated(stopped due to new methods of treatment, no more patients appilicable for study)
MoTriColor: A Phase II Study of Vinorelbine in Advanced BRAF-like Colon Cancer [NCT03482362]Phase 282 participants (Anticipated)Interventional2018-03-01Recruiting
A Randomized, Open-label, Parallel Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer [NCT03854617]Phase 2172 participants (Anticipated)Interventional2019-02-20Not yet recruiting
Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer [NCT06107790]Phase 3570 participants (Actual)Interventional2018-05-16Completed
A Phase 3 Asian Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer (MBC) Who Have Fail [NCT04639986]Phase 3331 participants (Actual)Interventional2020-11-23Active, not recruiting
PAV-trial: Plerixafor and Chemotherapy With Vinorelbine for Stem Cell Mobilization in Patients With Myeloma. A Pilot Phase II Study. [NCT01220375]Phase 244 participants (Actual)Interventional2010-04-30Completed
A Phase II, Single-Arm, Multi-Center Study Evaluating the Combination of Vinorelbine and Lapatinib in Women With ErbB2 Overexpressing Metastatic Breast Cancer [NCT00709618]Phase 244 participants (Actual)Interventional2008-06-30Terminated(stopped due to Evolving standard of care practices in this disease setting was limiting enrolment and leading to a delay in delivering this study information to the public.)
Neoadjuvant Camrelizumab Combined to Vinorelbine and Cisplatin as Second Regimen to Non-optimal Response to Taxanes and Anthracyclines on Patients With Early Stage HER2-negative Breast Cancer: A Single Arm Phase 2 Trial [NCT04848454]Phase 230 participants (Anticipated)Interventional2021-11-20Recruiting
A Phase 1/2 Study Of HKI-272 In Combination With Vinorelbine In Subjects With Solid Tumors And Metastatic Breast Cancer [NCT00706030]Phase 1/Phase 292 participants (Actual)Interventional2008-04-29Completed
A Non-Randomized Phase III Study of Response Adapted Therapy for the Treatment of Children With Newly Diagnosed High Risk Hodgkin Lymphoma [NCT01026220]Phase 3166 participants (Actual)Interventional2009-12-07Completed
Phase II Study of Weekly Vinorelbine and Paclitaxel in Elderly Patients With Advanced Non-Small Cell Lung Cancer [NCT00602797]Phase 220 participants (Actual)Interventional2007-12-17Completed
A Phase II, Randomised, Multi-Centre Study Evaluating Lapatinib in Combination With Vinorelbine or Capecitabine in Women With ErbB2 Overexpressing Metastatic Breast Cancer [NCT01013740]Phase 2112 participants (Actual)Interventional2009-11-25Completed
A Randomized Phase III, Double-blind, Placebo-controlled Multicenter Trial of Daily Everolimus in Combination With Trastuzumab and Vinorelbine, in Pretreated Women With HER2/Neu Over-expressing Locally Advanced or Metastatic Breast Cancer. [NCT01007942]Phase 3569 participants (Actual)Interventional2009-10-31Completed
A Phase 1 Study Of Neratinib (HKI-272) In Combination With Vinorelbine In Japanese Subjects With Advanced Or Metastatic Solid Tumors [NCT00958724]Phase 16 participants (Actual)Interventional2009-07-31Completed
Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed Versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients With Unresectable, Locally Advanced, Stage I [NCT00686959]Phase 3598 participants (Actual)Interventional2008-09-30Completed
Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in the Treatment of Advanced Breast Cancer [NCT05856383]100 participants (Anticipated)Observational2022-03-16Recruiting
Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy [NCT03393741]35 participants (Anticipated)Observational2018-01-29Recruiting
A Randomized, Open-Label, Multiple-center, Phase II Study to Evaluate the Efficacy and Safety of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Chinese Patients With HER2+ Metastatic Breast Cancer Who Have Received Pri [NCT04262804]Phase 2123 participants (Actual)Interventional2020-01-13Active, not recruiting
A Phase I Clinical Trial of Vorinostat in Combination With Vinorelbine in Patients With Advanced Cancer. [NCT00801151]Phase 130 participants (Anticipated)Interventional2009-01-31Terminated
A Randomized Phase III Study of Vitamins B6 and B12 to Prevent Chemotherapy-Induced Neuropathy in Cancer Patients. [NCT00659269]Phase 3319 participants (Actual)Interventional2006-07-31Completed
Phase I Open Label Trial to Assess Safety of BIBW 2992 With Vinorelbine in Solid Tumors Known to Overexpress HER2 and/or EGFR [NCT00906698]Phase 155 participants (Actual)Interventional2009-06-30Completed
Feasibility and Efficacy of Molecular Analysis-Directed Individualized Therapy Based of Tumoral mRNA Levels of ERCC1, RRM1 and BRCA1 in Advanced Non-Small-Cell Lung Cancer [NCT00705549]Phase 288 participants (Actual)Interventional2008-02-29Terminated(stopped due to Due to poor accrual)
A Phase I-II Study of Induction Chemotherapy With Carboplatin and Gemcitabine, Followed by Chemoradiotherapy With Paclitaxel and Vinorelbine for Patients With Locally Advanced Non-Small Cell Lung Cancer [NCT00004093]Phase 1/Phase 236 participants (Actual)Interventional1999-08-31Terminated(stopped due to Original Principal Investigator left the institution.)
A Randomized, Open-label Phase III Trial to Evaluate the Efficacy and Safety of Pertuzumab Retreatment in Previously Pertuzumab, Trastuzuamb and Chemotherapy Treated Her2-Positive Metastatic Advanced Breast Cancer [NCT02514681]Phase 3370 participants (Anticipated)Interventional2015-08-01Active, not recruiting
EndostarTM Injection Combined With Gemcitabine+Platinum (GP)/Navelbine+Platinum (NP)/Gemcitabine+Xeloda (GX)/Navelbine+Xeloda (NX) in Treatment of Recurrent Metastatic Breast Cancer: A Randomized, Opened and Controlled Clinical Study [NCT02489409]Phase 2120 participants (Anticipated)Interventional2015-10-31Recruiting
A Randomized, Open-label, Active-controlled, Phase II Study of Intravenous Anetumab Ravtansine (BAY 94-9343) or Vinorelbine in Patients With Advanced or Metastatic Malignant Pleural Mesothelioma Overexpressing Mesothelin and Progressed on First Line Plati [NCT02610140]Phase 2248 participants (Actual)Interventional2015-12-03Completed
Maintenance Metronomic Per OS Navelbine In Advanced NSCLC Patients After Previous Platinum Based Chemotherapy: A Multicenter Randomized Best Supportive Care Controlled Phase II Study - MA.NI.LA. Trial [NCT02176369]Phase 2120 participants (Actual)Interventional2013-02-28Completed
A Single Institution Prospective Randomized Controlled Clinical Trial of Neo-adjuvant Chemoradiotherapy Followed by Mckeown Minimally Invasive Esophagectomy (MIE) Versus Mckeown MIE for Locally Advanced Squamous Cell Esophageal Carcinoma [NCT02188615]Phase 2120 participants (Anticipated)Interventional2011-06-30Recruiting
CAMPFIRE: Children's and Young Adult Master Protocol for Innovative Pediatric Research [NCT05999994]Phase 2105 participants (Anticipated)Interventional2020-01-22Recruiting
A Randomized, Multicenter, Phase II Open-label Study of the Efficacy and Safety of Pyrotinib + Vinorelbine vs. Treatment of Physician's Choice in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- [NCT03997539]Phase 2256 participants (Anticipated)Interventional2019-08-15Not yet recruiting
A Phase I/Ib Trial of Trotabresib (BMS-986378), an Oral BET Inhibitor) in Combination With Vinorelbine and Radiation Therapy in HER2+ Breast Cancer Patients With Central Nervous System Metastasis and Leptomeningeal Disease (CA076-1008) [NCT06137651]Phase 134 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Vinorelbine Plus Gemcitabine (VG) Versus Vinorelbine Plus Carboplatin (VC) in Advanced Non-small Cell Lung Cancer. An Open Randomized Multicenter Phase III Trial From Norwegian Lung Cancer Study Group (NLCG) [NCT00737867]Phase 3444 participants (Anticipated)Interventional2007-09-30Completed
A Bioequivalence Study of Vinorelbine Tartrate Injectable Emulsion (ANX-530) in Patients With Advanced Cancer. [NCT00432562]Phase 131 participants (Actual)Interventional2007-02-28Completed
A Phase II Randomized Study of the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Physician Choice Chemotherapy in Premenopausal or Perimenopausal Patients With Hormone Receptor-positive/ HER2-negative Inoperable Locally Adv [NCT03839823]Phase 2223 participants (Actual)Interventional2019-02-25Completed
Phase II Prospective Study Evaluating the Role of Directed Cisplatin Based Chemo With Either Vinorelbine or Pemetrexed for the Adj Tx of Early Stage NSCLC in Patients Using Genomic Expression Profiles of Chemo Sensitivity to Guide Therapy [NCT00545948]Phase 231 participants (Actual)Interventional2007-12-31Terminated(stopped due to Study terminated due to reproducibility issues with genomics prediction model.)
A Phase II Study of Bortezomib (Velcade, PS-341) in Combination With Ifosfamide/Vinorelbine in Pediatric Patients and Young Adults With Refractory/Recurrent Hodgkin Disease [NCT00381940]Phase 226 participants (Actual)Interventional2007-01-31Completed
A Randomized Open-Label, Phase II Study of Lapatinib-capecitabine or Lapatinib-vinorelbine or Lapatinib/Gemcitabine in Subjects With Her2/Neu Amplified Metastatic Breast Cancer Patients Progression After Taxanes Treatment [NCT01050322]Phase 2142 participants (Actual)Interventional2009-11-30Completed
Navelbine, Taxol, Herceptin and Neupogen in Stage IV Breast Cancer: A Phase I - II Trial [NCT00041470]Phase 1/Phase 238 participants (Actual)Interventional2001-03-31Terminated(stopped due to Sponsor withdrew the study)
A Phase I/II Trial Of Temozolomide And Vinorelbine For Patients With Recurrent Brain Metastases [NCT00026494]Phase 1/Phase 249 participants (Actual)Interventional2001-07-31Completed
Combination of Continuous Low Doses of Vinorelbine, Cyclophosphamide and Interferon Alpha 2b for Antiangiogenic/Antivascular Effect in Adult Advanced Neoplasm [NCT00908869]Phase 130 participants (Actual)Interventional2006-05-31Completed
A Phase II, Single-center, Randomized Study of Vinorelbine Plus Apatinib Versus Vinorelbine as Second-Line or Third-Line Treatment in Patients With Advanced Triple-Negative Breast Cancer (NAN Trail) [NCT03254654]Phase 266 participants (Actual)Interventional2017-08-16Completed
Phase II Clinical Trial With Metronomic Oral Vinorelbine and Tri-weekly Cisplatin as Induction Therapy and Subsequent Concomitantly With Radiotherapy (RT) in Patients With Lung Cancer (NSCLC) Locally Advanced Unresectable [NCT02709720]Phase 267 participants (Actual)Interventional2016-04-15Completed
A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - [NCT03355157]Phase 4150 participants (Anticipated)Interventional2018-03-01Recruiting
The Efficacy and Safety of Chidamide Combined With VDDT Regimen(Vinorelbine,Liposomal Doxorubicin,Dexamethasone and Thalidomide) in Relapse and Refractory Patients With Diffuse Large B Cell Lymphoma [NCT02733380]Phase 220 participants (Anticipated)Interventional2016-05-31Recruiting
A Phase 1 Study of the Safety, Pharmacokinetics, and Biological Activity of Metronomic Dosing With Orally Administered Vinorelbine Tablets in Subjects With Non-Hematologic Malignancies For Which There Are No Currently Accepted Therapies [NCT00641160]Phase 112 participants (Anticipated)Interventional2008-03-31Active, not recruiting
GUided Treatment Based on Mini-PDX in metastaTIc refractOry Triple Negative Breast Cancer(GUMPTION):a Prospective Randomized Controlled Single Center Clinical Trial [NCT04745975]Phase 2100 participants (Anticipated)Interventional2021-02-01Recruiting
A Randomized Evaluation of Vinorelbine Versus Gemcitabine for Mobilization of Peripheral Stem Cells in Myeloma Patients Undergoing Autologous Stem Cell Transplantation. [NCT02791373]Phase 2136 participants (Actual)Interventional2014-03-31Completed
Platinum Retreated in Second- or Third-line Patients With Platinum Sensitive Metastatic Triple Negative Breast Cancer (Randomised, Phase II, NPN Trial) [NCT02607215]Phase 284 participants (Anticipated)Interventional2015-11-30Recruiting
Liposomal Mitoxantrone Hydrochloride, Gemcitabine, Vinorelbine With or Without Rituximab (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma [NCT05299164]Phase 124 participants (Anticipated)Interventional2022-05-15Not yet recruiting
IGEV +/- Bortezomib (Velcade) as Induction Before High Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma After First Line Treatment: a Randomized Phase II Trial. On Behalf of Intergruppo Italiano Linfomi [NCT00636311]Phase 213 participants (Actual)Interventional2008-02-29Completed
Oral Vinorelbine And Cisplatin With Concomitant Radiotherapy Followed By Either Consolidation Therapy With Oral Vinorelbine And Cisplatin Plus Best Supportive Care Or Best Supportive Care Alone In Stage III Non Small Cell Lung Cancer (NSCLC), A Randomized [NCT00683514]Phase 3201 participants (Actual)Interventional2005-04-30Completed
Randomized Phase III Trial Comparing Vinorelbine vs. Gemcitabine Plus Vinorelbine in Patients With Advanced Breast Cancer, Previously Treated With Anthracyclines and Taxanes [NCT00128310]Phase 3252 participants (Actual)Interventional2001-01-18Completed
A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma [NCT00881387]Phase 20 participants (Actual)Interventional2009-02-28Withdrawn
A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy [NCT06081959]Phase 3376 participants (Anticipated)Interventional2023-11-30Not yet recruiting
Phase II Trial of Cetuximab in Combination With Chemotherapy (Carboplatin and Navelbine) for Patients With Platinum-resistant Head and Neck Cancer [NCT01020864]Phase 20 participants (Actual)Interventional2010-01-31Withdrawn
A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients [NCT00325234]Phase 2135 participants (Actual)Interventional2006-06-30Completed
Phase II Study Evaluating Treatment With Oral Navelbine and Cisplatin Administered Weekly and Concomitant Radiotherapy in Elderly Patients With no Operable NSCLC [NCT01029678]Phase 248 participants (Actual)Interventional2010-01-31Completed
TNM Trial: Upfront Docetaxel [T] and Alternating iv and Oral Vinorelbine [N] Followed, by Either Maintenance Oral Vinorelbine, or Observation for Advanced Breast Cancer [NCT02144194]Phase 265 participants (Actual)Interventional2012-03-31Active, not recruiting
Almonertinib Plus Metronomic Oral Vinorelbine Beyond Limited Progression on Third-generation TKI in EGFR-mutant Advanced NSCLC,an Observational Study [NCT05663177]40 participants (Anticipated)Observational [Patient Registry]2022-12-20Not yet recruiting
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer [NCT01325428]Phase 226 participants (Actual)Interventional2011-08-31Completed
Phase I/II Study of Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer [NCT00912275]Phase 1/Phase 246 participants (Actual)Interventional2008-11-24Completed
Open-label, Randomized, Controlled, Multicenter Phase II Trial Investigating 2 Cilengitide Regimens in Combination With Cetuximab and Platinum-based Chemotherapy (Cisplatin/Vinorelbine or Cisplatin/Gemcitabine) Compared to Cetuximab and Platinum-based Che [NCT00842712]Phase 2232 participants (Actual)Interventional2009-02-28Completed
Vinorelbine Metronomic Plus Lapatinib as Salvage Therapy for Patients With Overexpressing HER-2 Metastatic Breast Cancer. A Multicenter Phase II Study [NCT00754702]Phase 216 participants (Actual)Interventional2008-10-31Terminated(stopped due to Poor accrual)
A Phase II Study of the Combination of Metronomic Vinorelbine and Bevacizumab as 2nd Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC) [NCT00755170]Phase 248 participants (Actual)Interventional2008-11-30Completed
A Single-arm, Open-label, Multicenter Feasibility Trial of Bevacizumab Given in Combination With Concomitant Chemoradiation (Cisplatin and Vinorelbine) in Locally Advanced Unresectable Non-squamous, Non-small Cell Lung Cancer [NCT00773188]Phase 16 participants (Actual)Interventional2008-12-31Completed
Assessment of Initial Oral Vinorelbine Dosing Schedules Used for the Treatment of Advanced Non-small-cell Lung Cancer and Metastatic Breast Cancer in Clinical Routine in Germany and Austria (StepUp) [NCT02619929]108 participants (Actual)Observational2016-02-29Completed
Phase 1 Study of Oral Vinorelbine in Combination With Erlotinib in Advanced Non-Small Cell Lung Cancer (NSCLC) Using Two Different Schedules [NCT00702182]Phase 130 participants (Actual)Interventional2008-04-30Completed
A Pilot Study of Docetaxel (Taxotere), Vinorelbine, and Bevacizumab, as Adjuvant Chemotherapy for Patients With Resected Stage I-III Non-small Cell Lung Cancer [NCT00675597]25 participants (Actual)Interventional2008-05-31Completed
Systemic Chemotherapy Combined With Thoracic Cavity Perfusion of Recombinant Human Adenovirus Type 5 and Endostatin Injections Versus Cisplatin for Treatment Malignant Hydrothorax in Non Small Cell Lung Cancer (NSCLC) Patients: A Multi-center, Randomized, [NCT02579564]Phase 3134 participants (Anticipated)Interventional2016-10-31Not yet recruiting
A Prospective Study of Metronomic Oral Vinorelbine in Combination With Sorafenib in Advanced Non-small Cell Lung Cancer a) A Phase I Dose-finding Study of the Combination of Metronomic Oral Vinorelbine and Sorafenib b) Pharmacokinetics Profiling of the Co [NCT00870532]Phase 152 participants (Actual)Interventional2008-06-30Completed
A Phase II Study Evaluating The Efficacy And Tolerability Of Everolimus (RAD001) In Combination With Trastuzumab And Vinorelbine In The Treatment Of Progressive HER2-Positive Breast Cancer Brain Metastases [NCT01305941]Phase 232 participants (Actual)Interventional2011-09-30Completed
Genotype-driven Treatment of Advanced Non-small Cell Lung Cancer Based on mRNA Expression of ERCC1 & RRM1 as First-line Chemotherapy [NCT00736814]Phase 2117 participants (Anticipated)Interventional2008-06-30Recruiting
A Phase II, Single Arm, Open Label Study to Evaluate the Efficacy and Safety of Trastuzumab and Vinorelbine in Advanced Breast Cancer Patients With Human Epidermal Growth Factor-2 (HER2) Negative Primary Tumors and HER2 Positive Circulating Tumor Cells [NCT01185509]Phase 231 participants (Actual)Interventional2010-11-30Terminated(stopped due to Not enough confirmed responses to continue treatment.)
Phase II Randomized Clinical Trial and Biomarker Analysis of Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin as Neoadjuvant Chemotherapy in Locally Advanced HER2-Negative Breast Cancer With TEKT4 Variations [NCT02628613]Phase 291 participants (Actual)Interventional2015-12-31Completed
Randomized, Open-label, Three-arm, Parallel, Phase 0 Study of Metronomic Oral Vinorelbine and Letrozole Versus Letrozole or Vinorelbine Alone in Post-menopausal Women With Hormone Receptor-positive HER2-negative Early Breast Cancer [NCT02802748]Early Phase 160 participants (Actual)Interventional2016-07-31Completed
[NCT02795884]Phase 30 participants (Actual)Interventional2016-06-30Withdrawn(stopped due to Because of reconsideration of using erlotinib(EGFR Tyrosine kinase inhibitor) as adjuvant aim)
A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan [NCT01196078]Phase 4114 participants (Actual)Interventional2007-02-28Completed
Advanced Non-small Cell Lung Cancer With Chinese Medicine Comprehensive Treatment Plan [NCT02777788]Phase 2/Phase 3120 participants (Anticipated)Interventional2014-09-30Active, not recruiting
Phase II Study of Treatment of Relapsed Agressive Lymphomas [NCT00842595]Phase 250 participants (Actual)Interventional2003-12-31Completed
Study Evaluating Vinorelbine Plus Capecitabine in the Treatment of Luminal B Breast Cancer Patients After Neoadjuvant Chemotherapy [NCT04307147]Phase 3316 participants (Anticipated)Interventional2018-07-03Recruiting
A Phase II Study to Assess the Effectiveness and Safety of Oral Vinorelbine or Capecitabine Combined With Trastuzumab as Adjuvant Treatment for Patients With Lymph Node Negative, HER-2 Positive and Small Tumor Size Breast Cancer (ORCHID) [NCT04296162]Phase 2178 participants (Anticipated)Interventional2019-03-01Recruiting
Endostar Combined With NVB and DDP Second-line Treatment of Advanced Esophageal Squamous Cell Carcinomas of the Prospective, Single Arm Phase II Clinical Study [NCT02665702]Phase 276 participants (Anticipated)Interventional2016-01-31Recruiting
A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer [NCT00706069]Phase 140 participants (Anticipated)Interventional2008-06-30Completed
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin [NCT02544243]Phase 2200 participants (Anticipated)Interventional2015-09-30Not yet recruiting
A Protocol for the Treatment of Newly Diagnosed Rhabdomyosarcoma Using Molecular Risk Stratification and Liposomal Irinotecan Based Therapy in Children With Intermediate and High Risk Disease [NCT06023641]Phase 1/Phase 2100 participants (Anticipated)Interventional2023-11-30Not yet recruiting
A Randomized, Open-label Trial of Gefitinib Versus Combination of Vinorelbine Plus Platinum as Adjuvant Treatment in Pathological Stage II-IIIA(N1-N2) Non-small Cell Lung Cancer With EGFR Mutation [NCT01405079]Phase 3222 participants (Actual)Interventional2011-09-19Active, not recruiting
A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras [NCT01410214]Phase 280 participants (Anticipated)Interventional2011-05-31Recruiting
Study Characterizing the Impact of Different Therapeutic Strategies on Event Occurrence at 2 Years, 5 Years, 10 Years, and 15 Years, According to Prognostic Groups in Patients With Hodgkin Lymphoma [NCT00920153]Phase 3442 participants (Actual)Interventional2008-05-31Terminated(stopped due to Other new drugs)
Capecitabine and Bevacizumab ± Vinorelbine as 1st Line Treatment in HER-2 Negative Metastatic or Locally Advanced Inoperable Breast Cancer Patients [NCT00868634]Phase 3600 participants (Actual)Interventional2009-02-28Completed
A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data [NCT00863512]Phase 334 participants (Actual)Interventional2009-03-31Terminated
A Phase â…¡ Randomized Clinical Trial Comparing Vinorelbine-ifosfamide With Gefitinib as Third-line Treatment in Advanced EGFR Gene Mutation Negative Non-small Cell Lung Cancer Patients [NCT01749072]Phase 2120 participants (Anticipated)Interventional2012-12-31Recruiting
Clinical Study to Assess Entry of Chemotherapeutic Agents Into Brain Metastases in Women With Breast Cancer [NCT00795678]10 participants (Actual)Observational2008-09-30Completed
Phase II Study of Apatinib Combined With Oral Vinorelbine in Pretreated Metastatic HER2 Negative Breast Cancer [NCT02768415]Phase 240 participants (Actual)Interventional2016-06-30Active, not recruiting
A Phase IB/II Trial of Combination of Vinorelbine With Sorafenib (BAY 43-9006) as First-Line Treatment in Patients With Metastatic Breast Cancer [NCT00764972]Phase 1/Phase 236 participants (Anticipated)Interventional2007-10-31Recruiting
Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2 [NCT04400695]Phase 3366 participants (Anticipated)Interventional2020-09-29Recruiting
PD-1 Immune Checkpoint Inhibitors and Immune-Related Adverse Events: a Cohort Study [NCT04115410]4,724 participants (Anticipated)Observational2020-07-01Not yet recruiting
Phase II Study With Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients Before High Dose Chemotherapy With Autologous Hematopoietic Stem Cells Transplant [NCT01884441]Phase 259 participants (Anticipated)Interventional2011-07-31Recruiting
Multicenter, Open-Ended, Double-Blind, Placebo-Controlled, Phase III Study of AE-941 in Addition to Combined Modality Treatment (Chemotherapy/Radiotherapy) for Locally Advanced Unresectable Non-Small Cell Lung Cancer [NCT00005838]Phase 3756 participants (Actual)Interventional2000-03-31Completed
A Research Study Evaluating Oral and Intravenous NAVELBINE as a Single Agent for the Treatment of Chemotherapy-Naive Subjects With Inoperable Stage IIIb or Stage IV Non-Small Cell Lung Cancer [NCT00005865]Phase 20 participants Interventional2000-04-30Completed
First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine [NCT00006114]Phase 20 participants Interventional1999-05-31Active, not recruiting
Phase I Trial of Combination Pegylated Liposomal Doxorubicin (Doxil), Vinorelbine, and Gemcitabine [NCT00006372]Phase 110 participants (Actual)Interventional2000-02-29Completed
An Open-Label Phase II Study of Navelbine (Vinorelbine Tartrate) and Taxotere (Docetaxel) as First-Line Therapy for Metastatic Breast Cancer [NCT00006682]Phase 20 participants Interventional2000-02-29Completed
A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease [NCT00006760]Phase 266 participants (Actual)Interventional2001-05-31Completed
Trans Retinoic Acid (Vesanoid) With Chemotherapy in Non-Small Cell Lung Cancer [NCT00005825]Phase 20 participants Interventional1998-09-30Active, not recruiting
A Phase I/II Study of Gemcitabine (GEMZAR)/Vinorelbine (NAVELBINE)/Liposomal Doxorubicin (DOXIL) in Relapsed/Refractory Hodgkin's Disease [NCT00006029]Phase 1/Phase 291 participants (Actual)Interventional2000-07-31Completed
A Randomized Phase III Study of Trastuzumab (Herceptin) in Combination With Either Vinorelbine (Navelbine), or Taxane-based Chemotherapy in Patients With HER2 Overexpressing Metastatic Breast Cancer [NCT00146549]Phase 3250 participants Interventional2001-08-31Completed
A Multicentre Phase II Study of Risk-adjusted Outpatient-based Salvage Therapy for Patients With Relapsed and Refractory Lymphoma [NCT00163761]Phase 290 participants (Actual)Interventional2002-12-31Completed
Real World Study of Inetetamab Combined With Pyrotinib and Vinorelbine as First-line to Third-line Treatment for Trastuzumab Resistant HER2-positive Metastatic Breast Cancer: a Multicenter, Retrospective Study [NCT05764941]100 participants (Anticipated)Observational2020-01-01Recruiting
A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma [NCT00256282]Phase 252 participants (Actual)Interventional2003-04-30Completed
INST 0601C: A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed, Advanced Non-Small Cell Carcinoma of the Lung [NCT00391586]Phase 245 participants (Actual)Interventional2006-07-31Terminated(stopped due to PI left institution.)
An Open-Label Phase I/II Study of Weekly ABI-007 and Vinorelbine With or Without G-CSF in Patients With Stage IV (Metastatic) Breast Cancer [NCT00140140]Phase 1/Phase 216 participants (Actual)Interventional2005-08-31Terminated(stopped due to Unable to determine the optimum tolerated dose)
A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma [NCT00337194]Phase 230 participants (Actual)Interventional2006-04-30Completed
A Phase III, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With Completely Resected Stage IB (Tumors Equal to or Larger Than 4cm) to Stage IIIA Anaplastic Lym [NCT03456076]Phase 3257 participants (Actual)Interventional2018-08-16Active, not recruiting
Phase I Trial of ZW25 in Patients With Locally Advanced (Unresectable) and/or Metastatic HER2-expressing Cancers [NCT02892123]Phase 1279 participants (Actual)Interventional2016-09-30Active, not recruiting
Phase I Study of Pazopanib in Combination With Vinorelbine in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) and Breast Cancer [NCT01060514]Phase 18 participants (Actual)Interventional2010-02-28Terminated(stopped due to Lack of timely accrual.)
Phase II Study of Capecitabine in Combination With Vinorelbine and Trastuzumab for the First- or Second-LineTreatment of HER2+ Metastatic Breast Cancer [NCT00093808]Phase 247 participants (Actual)Interventional2004-08-31Completed
Phase II Trial of Oral Vinorelbine in Children With Recurrent or Progressive Unresectable Low-Grade Glioma [NCT02197637]Phase 239 participants (Actual)Interventional2014-05-31Completed
Phase I, Prospective, Open-label, Multi-centric, Dose Finding Trial of Combination of IGEV and Panobinostat Before Autologous Stem Cell Transplant in Patients With Hodgkin's Lymphoma [NCT01884428]Phase 124 participants (Anticipated)Interventional2011-07-31Recruiting
Randomized Phase II Trial of Capecitabine Plus Oral Vinorelbine Day 1 and 8 vs Metronomic Capecitabine Plus Oral Vinorelbine as Treatment of Metastatic Breast Cancer. [NCT01941771]Phase 2110 participants (Actual)Interventional2012-06-30Completed
A Phase II Study of Vinorelbine in Unresectable or Metastatic Esophageal and Gastric Adenocarcinoma [NCT00215462]Phase 232 participants Interventional2000-06-30Completed
A Multicentre, Randomized Study of Trastuzumab Combined With Chemotherapy or Endocrine Therapy as the First Line Treatment for Patients With Metastatic Luminal B2 Breast Cancer Subtype [NCT01950182]Phase 3392 participants (Actual)Interventional2013-09-16Completed
A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study [NCT00225173]Phase 245 participants (Anticipated)Interventional2001-10-31Terminated
A Randomized, Phase II Study Comparing Trastuzumab and Vinorelbine in Combination With Avelumab or Avelumab and Utomilumab (41BB/CD137 Agonist), in Patients With HER2-positive Metastatic Breast Cancer Who Have Progressed on Prior Trastuzumab and Pertuzuma [NCT03414658]Phase 2100 participants (Anticipated)Interventional2018-06-21Active, not recruiting
A Phase I Absolute Bioavailability Study of Oral NAVELBINE (Vinorelbine Tartrate) in Patients With Solid Tumors [NCT00006088]Phase 10 participants Interventional2000-06-30Active, not recruiting
Organoid-Guided Functional Precision Therapy Versus Treatment of Physician's Choice in Previously Treated HER2-negative Advanced Breast Cancer: A Phase II, Multicenter, Open-label, Randomized Controlled Trial [NCT06102824]Phase 2252 participants (Anticipated)Interventional2024-01-20Recruiting
A Single-arm, Multi-center Phase II Clinical Study of Pyrotinib Combined With Vinorelbine in the Treatment of HER2-positive and Treated Metastatic Breast Cancer [NCT04605575]Phase 2208 participants (Anticipated)Interventional2020-05-22Recruiting
Neoadjuvant Complete Hormonal Blockade Followed by Neoadjuvant Chemotherapy for Resectable Hormone Receptor Positive, HER-2/Neu Negative Breast Cancer, A Phase II Study [NCT00194792]Phase 228 participants (Actual)Interventional2005-08-31Terminated
A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Trial Of JSKN003 Versus Treatment Of Physician'S Choice For HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [NCT06079983]Phase 3400 participants (Anticipated)Interventional2023-12-01Not yet recruiting
A Phase I Trial of the Hypoxia Modifier Atovaquone in Combination With Radical Concurrent Chemoradiotherapy in Locally Advanced Non-Small Cell Lung Cancer [NCT04648033]Phase 121 participants (Actual)Interventional2020-12-07Completed
[NCT01648517]Phase 260 participants (Actual)Interventional2012-07-27Completed
Effect of Endostar Combined With Chemotherapy and Radiotherapy on Blood Vessels and Microenvironment of Tumor for Non-small Cell Lung Cancer [NCT01687439]Phase 215 participants (Actual)Interventional2008-12-31Completed
Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study [NCT01109524]Phase 272 participants (Actual)Interventional2010-07-31Completed
A Phase I Study of Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine With Filgrastim Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer [NCT00724386]Phase 126 participants (Actual)Interventional1999-06-30Completed
A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status [NCT01038037]Phase 223 participants (Actual)Interventional2010-01-31Terminated(stopped due to "Very low enrollment rate.~Recent studies question the effect of adding panitumumab in this category of patients.~Too high toxicity rate")
Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Patients With Metastatic Breast Cancer. A Multicenter Phase II Study [NCT00694200]Phase 213 participants (Actual)Interventional2008-04-30Terminated(stopped due to Not reached the statistical hypothesis at the interim analysis)
A Phase II Trial of Gemcitabine (Gemzar) Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer [NCT00192062]Phase 280 participants Interventional2004-07-31Completed
A Randomized Phase II Trial To Evaluate The Efficacy And Safety Of Vandetanib (ZD6474, ZACTIMA â„¢) Versus Vinorelbine In Patients With Inoperable Or Relapsed Malignant Mesothelioma. [NCT00597116]Phase 225 participants (Actual)Interventional2007-12-31Terminated(stopped due to Recruitment stopped according to early stopping rule (by protocol))
A Randomized Open Study of Metronomic Oral Vinorelbine in Combination With Aromatase Inhibitors for the Treatment of Postmenopausal Women With Hormone Receptor Positive,HER2-negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disea [NCT02730091]Phase 398 participants (Actual)Interventional2016-02-24Terminated
A Randomized Phase II Trial of Bevacizumab (Avastin) and Temsirolimus (Torisel) in Combination With Intravenous Vinorelbine and Cyclophosphamide in Patients With Recurrent/Refractory Rhabdomyosarcoma [NCT01222715]Phase 287 participants (Actual)Interventional2010-10-31Completed
Sequential Cisplatin/Vinorelbine/Bevacizumab Followed by Docetaxel/Gemcitabine/Bevacizumab Versus Cisplatin/Docetaxel/Bevacizumab in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer [NCT00620971]Phase 277 participants (Actual)Interventional2008-01-31Completed
Phase 2 Randomized Study Evaluating 3 Chemotherapy Regimens as Second-line Treatment in Patients With Hormone-refractory Metastatic Prostate Cancer [NCT00627354]Phase 290 participants (Anticipated)Interventional2006-09-30Completed
Observational Study With Metronomic Oral Vinorelbine in Elderly Patients With Locally Advanced / Metastatic Non-small-cell Lung Cancer (NSCLC) [NCT04208854]40 participants (Anticipated)Observational2018-04-18Recruiting
Randomized Multicenter Phase II Study of Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine as First Line Chemotherapy for Patients With Metastatic Breast Cancer [NCT00629148]Phase 260 participants (Actual)Interventional2007-08-31Completed
Tocotrienol as a Nutritional Supplement in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) [NCT02644252]Phase 379 participants (Actual)Interventional2016-01-31Terminated(stopped due to The trial was ended prematurely because of a poor accrual rate)
A Controlled, Phase II Study of Anlotinib vs Placebo Combination With Vinorelbine for the Treatment of HER2- Advanced Breast Cancer [NCT05296577]Phase 2134 participants (Anticipated)Interventional2022-03-22Recruiting
LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment [NCT01125566]Phase 3508 participants (Actual)Interventional2010-06-22Completed
Multicentre Randomised Phase II Trial of Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients (=/> 70 Years) With Advanced Non-Small Cell Lung Cancer [NCT00678964]Phase 2260 participants (Anticipated)Interventional2006-06-30Recruiting
A Study to Evaluate Vinorelbine Plus Capecitabine Combined With Trastuzumab as the Adjuvant Treatment of HER2 Positive Patients Following Neoadjuvant Chemotherapy [NCT04302441]Phase 2550 participants (Anticipated)Interventional2016-11-10Recruiting
Precise Treatment for BLIS Subtype of Triple-negative Breast Cancer in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer [NCT05806060]Phase 3192 participants (Anticipated)Interventional2023-04-25Recruiting
INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer [NCT00277069]Phase 1/Phase 233 participants (Actual)Interventional2000-05-31Completed
Phase I Study of Two Different Schedules of Lapatinib (GW572016) in Combination With Vinorelbine in Advanced Solid Tumors [NCT00389922]Phase 122 participants (Actual)Interventional2005-12-31Completed
A Pilot Study of Outpatient Vinorelbine and Gemcitabine With Filgrastim Support for Patients With Relapsed or Refractory Lymphoma. [NCT00163748]Phase 240 participants Interventional2001-02-28Completed
Phase III Randomized Study of Paclitaxel, Carboplatin, and Gemcitabine Versus Gemcitabine and Vinorelbine as First-Line Chemotherapy for Stage IIIB and IV Non-Small Cell Lung Cancer [NCT00193362]Phase 3200 participants Interventional2004-06-30Completed
Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer: A Phase II Trial With Molecular Correlates [NCT00194727]Phase 240 participants (Actual)Interventional2002-05-31Completed
A Phase II Study of Docetaxel and Vinorelbine in Advanced Non-Small Cell Lung Carcinoma [NCT00006215]Phase 20 participants Interventional1999-10-31Active, not recruiting
Randomized Phase II Study Evaluating an Induction Chemotherapy Followed by a Concomitant Chemoradiotherapy and a Concomitant Chemoradiotherapy Followed by a Consolidation Chemotherapy Among Patients With NSCLC Stage III Not Resectable [NCT00198432]Phase 2130 participants Interventional2002-03-31Completed
Phase I Study Evaluating the Combination of Lapatinib + Vinorelbine in Patients With Locally Advanced or Metastatic Breast Cancer Overexpressing HER2 [NCT00513058]Phase 133 participants (Actual)Interventional2007-06-30Completed
Phase I/II Evaluation of Oral Estramustine and Oral Vinorelbine on an Intermittent Schedule in Patients With Hormone-Refractory Adenocarcinoma of the Prostate [NCT00151086]Phase 1/Phase 233 participants (Actual)Interventional2001-12-31Completed
Randomized Cross-over Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC. A Phase IV Study. [NCT01848613]Phase 4120 participants (Anticipated)Interventional2012-10-31Completed
A Phase I/IIa, Open Label, Dose-escalation Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenous Liposomal Vinorelbine Tartrate Injection in Patients With Advanced Malignancy [NCT02925000]Phase 1/Phase 246 participants (Actual)Interventional2017-06-19Completed
A Phase I/II Basket Trial Evaluating a Combination of Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumour [NCT03518606]Phase 1/Phase 2150 participants (Anticipated)Interventional2018-06-20Active, not recruiting
A Study to Evaluate Navelbine in Combination With Trastuzumab Plus Pertuzumab in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer in Neoadjuvant Treatment [NCT04665986]Phase 350 participants (Anticipated)Interventional2021-03-01Not yet recruiting
A Muti-center, Open-label, Randomized, Phase III Study of Camrelizumab Plus Treatment of Physician Choice Versus Treatment of Physician Choice for Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Systemic Chemotherapy Regimens for [NCT05134194]Phase 3104 participants (Anticipated)Interventional2021-11-30Not yet recruiting
Phase IA/IB of Metronomic Chemotherapy Based on Adaptative Bio-mathematical Model of Oral Vinorelbine in Patients With Non Small Cell Lung Cancer or Malignant Pleural Mesothelioma [NCT02555007]Phase 130 participants (Actual)Interventional2015-08-26Completed
Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC [NCT02998528]Phase 3505 participants (Actual)Interventional2017-03-04Active, not recruiting
A Major Randomised Trial to Determine the Value of Cisplatin-Based Chemotherapy For All Patients With Non-Small Cell Lung Cancer [NCT00003240]Phase 31,800 participants (Anticipated)Interventional1995-10-31Active, not recruiting
Randomized Phase III Multicenter Trial of Customized Chemotherapy Versus Standard of Care for1st Line Treatment of Elderly Patients With Advanced Non-Small-Cell Lung Cancer [NCT03402048]Phase 3567 participants (Anticipated)Interventional2012-07-31Recruiting
A Phase III, Open Label, Randomised, Multi-centre, International Study of MEDI4736, Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non-Small C [NCT02352948]Phase 3597 participants (Actual)Interventional2015-01-13Completed
Single Agent Chemotherapy With Weekly Docetaxel vs Combination Chemotherapy in Second-line Treatment of Advanced Non Small Cell Lung Cancer [NCT00345059]Phase 384 participants (Actual)Interventional2005-05-31Terminated(stopped due to slow accrual)
A Randomised Phase III Study of Trastuzumab-Docetaxel vs Trastuzumab-Vinorelbine as 1. Line Therapy for Patients With Metastatic HER2 Positive Breast Cancer [NCT00430001]Phase 3300 participants (Anticipated)Interventional2005-05-31Recruiting
Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine as First Line Treatment in Patients With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC). A Prospective , Multicenter, Randomized, Phase III Trial [NCT00441740]Phase 3419 participants (Actual)Interventional2004-04-30Completed
A Phase I Study of Post-transplant Autologous Cytokine-induced Killer (CIK) Cells for the Treatment of High-risk Hematologic Malignancies [NCT00477035]Phase 122 participants (Actual)Interventional2006-05-31Completed
[NCT02940990]Phase 250 participants (Anticipated)Interventional2016-11-30Not yet recruiting
Open-label, Multicenter, Randomized Phase II Trial of Treatment With Cisplatin and Pemetrexed or Cisplatin and Oral Vinorelbine in Chemotherapy Naïve Patients Affected by Stage IIIB-IV Non-Squamous Non-Small Cell Lung Cancer With High Thymidylate Synthase [NCT02919462]Phase 22 participants (Actual)Interventional2016-03-31Terminated(stopped due to low recruitement rate)
A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer [NCT02585388]Phase 2120 participants (Actual)Interventional2015-10-23Terminated(stopped due to Treatment toxicity)
A Phase II Study of Gemcitabine in Combination With Vinorelbine vs. Sequential Gemcitabine Followed by Vinorelbine in Metastatic Breast Cancer [NCT00532623]Phase 282 participants (Actual)Interventional2004-05-31Completed
Pilot Study Targeting Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer As Part of Adjuvant Therapy and Preventive Strategy [NCT01209520]6 participants (Actual)Interventional2009-07-31Completed
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer [NCT04681911]Phase 271 participants (Anticipated)Interventional2020-09-09Recruiting
A Clinical Study to Investigate the Efficacy and Safety of Combination of Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Patients With Advanced Non-Small Cell Lung Cancer [NCT02985203]Phase 245 participants (Actual)Interventional2016-11-30Terminated(stopped due to No participants were enrolled as schedule.)
Treatment of Peripheral T-cell Lymphoma With Aggressive Induction Chemotherapy Followed by Autologous Stem Cell Transplant Using Denileukin Diftitox (Ontak) for In-vivo Purging and Post-Transplant Therapy: A Multicenter Phase II Clinical Trial [NCT00632827]Phase 221 participants (Actual)Interventional2008-07-01Terminated(stopped due to Manufacturing shortage of both Diftitox and Doxil)
A Clinical Trial of the P-Glycoprotein Antagonist, XR9576, in Combination With Vinorelbine in Patients With Cancer: Analysis of the Interaction Between XR9576 and Vinorelbine [NCT00001944]Phase 130 participants Interventional1999-12-31Completed
A Phase II Study of Navelbine (Vinorelbine) In Children With Recurrent Or Refractory Malignancies [NCT00003234]Phase 250 participants (Actual)Interventional1998-05-31Completed
Evaluation of Vinorelbine Tartrate (Navelbine) in Patients With Disseminated Malignant Melanoma and One Prior Systemic Therapy [NCT00003828]Phase 224 participants (Actual)Interventional1999-05-31Completed
A Randomized Controlled Trial of Active Symptom Control With or Without Chemotherapy in the Treatment of Patients With Malignant Pleural Mesothelioma [NCT00075699]Phase 3840 participants (Anticipated)Interventional2003-09-30Completed
A Randomized Study of Weekly Vinorelbine (Navelbine®) Alone or in Combination With Trastuzumab (Herceptin®) (NSC-688097) for Patients With HER-2-Positive Metastatic Breast Cancer Whose Tumors Have Progressed After Taxane + Trastuzumab Combination Therapy [NCT00103233]Phase 30 participants Interventional2004-12-31Completed
Randomised Phase II/III Trial of Induction Chemotherapy Followed by Continuous Hyperfractionated Accelerated Radiotherapy (CHART) Versus CHART Alone in Patients With Inoperable Non-Small Cell Lung Cancer [NCT00253591]Phase 2/Phase 3500 participants (Anticipated)Interventional2005-06-30Completed
A Phase II Study Of Weekly Gemcitabine And Vinorelbine In Children With Recurrent Or Refractory Hodgkin's Disease [NCT00070304]Phase 233 participants (Actual)Interventional2004-07-31Completed
A Randomised, Open Label, Parallel Group, Multi-Centre, Phase II Study of Progression Free Survival Comparing ZD1839 (IRESSAâ„¢) (250 MG Tablet) Versus Vinorelbine (30 MG/M2 Infusion) in Chemonaive, Elderly Patients With Locally Advanced (Stage IIIB) or Met [NCT00256711]Phase 2192 participants Interventional2004-07-31Completed
A Single-centre Phase 2 Study of Vinorelbine Plus 3-weekly Trastuzumab in Metastatic Breast Cancer Overexpressing Her-2 [NCT00401427]Phase 250 participants Interventional2002-11-30Completed
Oral Vinorelbine and Cisplatin and Concurrent Radiotherapy After Induction Chemotherapy With Cisplatin-docetaxel in Patients With Locally Advanced Non-small-cell Lung Cancer. A Multicenter Phase II Trial [NCT00295672]Phase 260 participants (Anticipated)Interventional2006-02-28Completed
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study [NCT05826964]Phase 2500 participants (Anticipated)Interventional2023-06-12Recruiting
A Phase II, Open-Label, Randomized Study Immunoconjugate L-DOS47 in Combination With Vinorelbine/Cisplatin Versus Vinorelbine/Cisplatin Alone in Patients With Lung Adenocarcinoma [NCT03891173]Phase 29 participants (Actual)Interventional2019-02-19Terminated(stopped due to Study was halted at this time due to other budgetary priorities. Completion of reporting has been delayed first due to covid restrictions and more recently due to war in Ukraine.)
A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA) [NCT04943627]Phase 30 participants (Actual)Interventional2021-08-02Withdrawn(stopped due to Strategic Business Decision)
Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial [NCT00434668]Phase 299 participants (Anticipated)Interventional2005-12-31Completed
A Multicenter Randomized Phase II Study of Docetaxel Versus Vinorelbine as First-Line Treatment in Elderly Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC) [NCT00441922]Phase 3166 participants (Anticipated)Interventional2003-01-31Completed
Cancer Immunotherapeutic GSK1572932A as Adjuvant Therapy for Patients With MAGE-A3-positive Non-Small Cell Lung Cancer [NCT00455572]Phase 171 participants (Actual)Interventional2007-05-11Terminated(stopped due to Study early termination was due to slow recruitment and difficulties at achieving the required enrolment for the study.)
Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients [NCT00401492]Phase 2159 participants (Actual)Interventional2002-06-30Completed
Evaluation of Activity and Toxicity of Polychemotherapy With 2-drug Combinations Containing Gemcitabine as First Line Treatment of Elderly Patients With Small Cell Lung Cancer [NCT00401609]Phase 1/Phase 285 participants Interventional2000-11-30Completed
A Phase I Dose Escalation Trial of Clofarabine in Addition to Topotecan, Vinorelbine, Thiotepa, and Dexamethasone in Pediatric Patients With Relapsed or Refractory Acute Leukemia [NCT00462787]Phase 123 participants (Actual)Interventional2007-04-30Completed
Research of Intensive Treatment in Hormone Receptor<10% and Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer Patients With Positive Lymph Node Residual Disease After Neoadjuvant Chemotherapy [NCT03270007]Phase 4304 participants (Anticipated)Interventional2017-11-10Recruiting
A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma [NCT00403988]Phase 240 participants (Anticipated)Interventional2004-06-30Terminated(stopped due to The results of a same study design have shown low response with important side effects. Accordingly & ethicly, the study has been stopped.)
Randomized Phase III-Study in Stage IIIb and IV Non-Small-Cell Lung Cancer. Sequential Single-Agent vs. Double-Agent vs. Triple-Agent Therapy. [NCT00148395]Phase 3280 participants Interventional2002-06-30Completed
Vinorelbine Versus Gemcitabine Versus Gemcitabine and Vinorelbine in Elderly Patients With Stage IIIB-IV Non-Small Cell Lung Cancer [NCT00003447]Phase 3630 participants (Anticipated)Interventional1998-07-31Active, not recruiting
Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy [NCT03007992]Phase 29 participants (Actual)Interventional2016-12-31Completed
A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA No [NCT02486718]Phase 31,280 participants (Actual)Interventional2015-10-31Active, not recruiting
Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2 [NCT00193089]Phase 260 participants (Actual)Interventional2001-04-30Completed
[NCT02897986]Phase 154 participants (Anticipated)Interventional2017-01-31Not yet recruiting
Phase II Study of Vinorelbine + Cyclofosfamide Association Among Patients Reached of Refractory Tumours or in Relapse [NCT00180947]Phase 2210 participants Interventional2003-06-30Recruiting
A Multicenter, Open-Label, Phase II Study of Lapatinib in Combination With Vinorelbine in Subjects With ErbB2 Amplified Recurrent and Metastatic Breast Cancer [NCT01128543]Phase 229 participants (Actual)Interventional2009-04-30Completed
An Open-label Phase I Study of Once Daily Oral Treatment With BIBW 2992 in Combination With Weekly Vinorelbine Intravenous Injection in Japanese Patients With Advanced Solid Tumours [NCT01214616]Phase 117 participants (Actual)Interventional2010-10-31Completed
A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline [NCT00431106]Phase 3144 participants (Anticipated)Interventional2002-04-30Completed
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Gemcitabine Plus Vinorelbine Versus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Capecitabine [NCT00480597]Phase 2141 participants (Actual)Interventional2002-10-31Completed
A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (Navelbine) or Gemcitabine (Gemzar) Plus Cisplatin as First Line Therapy in Patients With Locally Advanced or Metastatic (Stage IIIB-IV) [NCT00496275]Phase 117 participants (Actual)Interventional2006-08-31Completed
A Phase II Investigation of Oral Vinorelbine in Combination With Trastuzumab for 1st and 2nd Line Treatment of Women With Metastatic HER2 Positive Breast Cancer [NCT01242449]Phase 210 participants (Actual)Interventional2010-11-30Completed
Randomized Phase II Study to Compare Vinorelbine In Combination With the mTOR Inhibitor Everolimus vs. Vinorelbin Monotherapy for Second-line Treatment in Advanced Breast Cancer [NCT01520103]Phase 2139 participants (Actual)Interventional2012-01-31Completed
A Prospective Phase II Trial of Vinorelbine Plus Oxaliplatin in Pretreated Metastatic Triple-negative Breast Cancer [NCT01528826]Phase 235 participants (Anticipated)Interventional2011-12-31Recruiting
Single-arm, Open-label, Multicentre Phase II Study Evaluating the Efficacy and Safety of BIBW 2992 (Afatinib) in Combination With Vinorelbine for the Treatment of Patients With Metastatic Breast Cancer With Intermediate HER2 Expression (HER2 2+ by Immunoh [NCT01531764]Phase 22 participants (Actual)Interventional2012-07-31Terminated(stopped due to The recruitment was discontinued because of failure to meet expected enrolment goals)
Oral Vinorelbine For The Treatment Of Metastatic Non-Small Cell Lung Cancer In Patients More Than Or Equal To 65 Years Of Age: A Phase II Trial of Efficacy and Patients Perceived Preference for Oral Therapy [NCT00008333]Phase 259 participants (Actual)Interventional2001-04-30Completed
Phase I Clinical Trial Of Vinorelbine (Navelbine) And Trastuzumab (Herceptin) In Patients With Carcinoma Of The Breast Or Non-Small Cell Lung Cancer And HER-2/NEU Overexpression [NCT00014430]Phase 113 participants (Actual)Interventional1999-11-30Completed
A Phase II Study of Bevacizumab in Combination With Vinorelbine in Stage IV Breast Cancer [NCT00017394]Phase 256 participants (Actual)Interventional2001-03-31Completed
A Randomized Phase II-III Trial Evaluating the Efficacy of Capecitabine and Vinorelbine in Anthracycline and Taxane Pre-Treated Metastatic Breast Cancer [NCT00049660]Phase 2/Phase 347 participants (Actual)Interventional2002-09-30Terminated(stopped due to low accrual)
Ibritumomab Tiuxetan and High-Dose Melphalan as Conditioning Regimen Before Autologous Stem Cell Transplantation for Elderly Patients With Lymphoma in Relapse or Resistant to Chemotherapy. A Multicenter Phase I Trial [NCT00392691]Phase 120 participants (Actual)Interventional2006-10-31Completed
A Phase I Study of Weekly Administration of Oral Navelbine in Combination With the COX-2 Inhibitor Celebrex in Relapsed and/or Metastatic Breast Cancer [NCT00075673]Phase 16 participants (Actual)Interventional2003-11-30Terminated
Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma [NCT00083083]Phase 2250 participants (Anticipated)Interventional2005-03-31Active, not recruiting
Docetaxel And Vinorelbine Plus Filgrastim For HER-2 Negative, Stage IV Breast Cancer [NCT00015938]Phase 295 participants (Actual)Interventional2001-05-31Completed
The International Tirazone Triple Trial (i3T): A Phase III, Randomized Efficacy And Safety Study Of The Combination Chemotherapy With Tirapazamine+Cisplatin+Vinorelbine Versus Cisplatin+Vinorelbine In Subjects With Inoperable, Previously Untreated, Non-Sm [NCT00017459]Phase 30 participants Interventional2000-07-31Completed
Phase II Trial of Oral Vinorelbine for the Treatment of Metastatic Breast Cancer in Patients >65 Years of Age: A Trial of Efficacy, Toxicity, and Patients' Perceived Preference for Oral Therapy [NCT00022152]Phase 225 participants (Actual)Interventional2001-11-30Completed
Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma [NCT00030459]Phase 20 participants Interventional2000-11-30Active, not recruiting
[NCT00042315]Phase 3490 participants Interventional2002-06-30Terminated
Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2 [NCT00026156]Phase 2125 participants (Actual)Interventional2001-11-30Completed
A Phase III Randomized, Open-Label Comparative Study of Induction Chemotherapy Followed by Thoracic Radiation Therapy With Supplemental Oxygen, With or Without Concurrent RSR13 (Efaproxiral), in Patients With Locally Advanced Unresectable (Stage IIIA/IIIB [NCT00055887]Phase 30 participants (Actual)Interventional2002-11-30Withdrawn(stopped due to Study never started. No patients were enrolled.)
Molecular And Genetic Changes In Patients With Resectable Non-Small Cell Lung Cancer (NSCLC) Following Neoadjuvant Chemotherapy With Vinorelbine And Gemcitabine - Phase II Study [NCT00057798]Phase 221 participants (Actual)Interventional2000-03-31Completed
Phase III Randomized Comparison Study of Vinorelbine, Gemcitabine, and Docetaxel Versus Paclitaxel and Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer [NCT00079287]Phase 30 participants Interventional2001-03-31Completed
Randomized Trial to Assess the Benefit of Adding Trastuzumab to Capecitabine and Vinorelbine as Second Line for HER2positive Breast Cancer Patients With Locally Advanced or Metastatic Disease, Previously Treated With Trastuzumab and Taxanes [NCT00130507]Phase 214 participants (Actual)Interventional2005-11-04Terminated(stopped due to A new alternative treatment caused the decrease in the rhythm of recruitment.)
A Phase II Study Evaluating Efficacy of the Combination of Gemcitabine and Vinorelbine in Advanced Soft Tissue Sarcoma [NCT00134641]Phase 240 participants Interventional2003-02-28Completed
Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer [NCT00148291]Phase 3180 participants Interventional1999-06-30Completed
Preoperative Herceptin and Navelbine in Early Stage, HER-2 Positive Breast Cancer [NCT00148681]Phase 249 participants (Actual)Interventional2001-05-31Completed
A Phase I Study of Oral Navelbine and Capecitabine in the Treatment of Metastatic Breast Cancer [NCT00153907]Phase 140 participants (Actual)Interventional2002-03-31Completed
A Phase II Trial of Doxil and Multiday Vinorelbine in Patients With Metastatic Breast Cancer [NCT00159094]Phase 230 participants (Anticipated)Interventional2003-10-31Recruiting
Phase II Trial of Cetuximab Plus Vinorelbine in Previously Untreated Patients > 70 With Advanced NSCLC [NCT00165334]Phase 253 participants Interventional2005-06-30Completed
CT-2103 vs Gemcitabine or Vinorelbine for the Treatment of PS = 2 Patients With Chemotherapy Naive Advanced Non-Small Cell Lung Cancer (NSCLC): A Phase III Study [NCT00054197]Phase 30 participants Interventional2003-01-31Terminated
Randomized Phase II Study to Determine the Efficacy of a Three Weekly vs. Weekly Therapy With Paclitaxel Plus Carboplatin vs. Paclitaxel Plus Vinorelbine for Patients With Non Small Cell Lung Cancer According to UICC Stage IIIB and IV [NCT00168883]Phase 280 participants Interventional2002-10-31Recruiting
A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer [NCT00193921]Phase 282 participants (Actual)Interventional2003-02-28Completed
Taxotere Plus Weekly Navelbine and G-CSF: A Phase II Study in Stage IV Breast Cancer [NCT00194740]Phase 248 participants (Actual)Interventional1997-11-30Completed
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) NSCLC. Randomized Phase II Study [NCT00198367]Phase 2120 participants (Actual)Interventional2003-01-31Completed
Randomized Phase III Multicenter Trial of RRM1 & ERCC1 Directed Customized Chemotherapy Versus Standard of Care for 1st Line Treatment of Patients With Advanced Non-Small-Cell Lung Cancer [NCT00499109]Phase 3275 participants (Actual)Interventional2007-05-31Completed
LUX-Breast 2; An Open Label, Phase II Trial of Afatinib (BIBW 2992) in Patients With Metastatic HER2-overexpressing Breast Cancer Failing HER2-targeted Treatment in the Neoadjuvant and/or Adjuvant Treatment Setting [NCT01271725]Phase 274 participants (Actual)Interventional2011-05-24Completed
Randomized Phase III Trial of Chemotherapy vs. Pembrolizumab Plus Chemotherapy for Relapsed/Refractory Classical Hodgkin Lymphoma [NCT05711628]Phase 30 participants (Actual)Interventional2023-08-10Withdrawn(stopped due to Other - Protocol moved to Withdrawn)
Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma [NCT00354393]Phase 29 participants (Actual)Interventional2002-08-31Completed
A Phase II, Single-arm, Two-cohorts, Open-label, Single Center Study of Surufatinib or Surufatinib Combined With Vinorelbine as Third-line and Posterior Line Treatment in Patients With Non-Small Cell Lung Cancer [NCT04922658]Phase 260 participants (Anticipated)Interventional2021-07-01Recruiting
A Phase II Trial of Sequential Epirubicin/Vinorelbine in Patients With Advanced Breast Cancer [NCT00176488]Phase 231 participants (Actual)Interventional2003-06-30Terminated(stopped due to Competing studies)
Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01 [NCT00235235]80 participants (Actual)Observational2005-09-30Terminated(stopped due to Funding terminated)
Metronomic Vinorelbine in Patients With Metastatic Tumors: Phase II Translational Study [NCT00278070]Phase 20 participants Interventional2006-01-31Completed
"Phase II Study of PET Guided Neoadjuvant Chemotherapy (NAC) and Oncotype Guided Hormonal Therapy of Breast Cancer" [NCT01641406]Phase 260 participants (Anticipated)Interventional2011-03-31Recruiting
A Pilot Study of Rituximab in Combination With Out-patient Based VGF/F-GIV Salvage Therapies for Relapsed/Refractory CD20+ Lymphomas [NCT00280878]Phase 212 participants (Anticipated)Interventional2006-01-31Completed
A Prospective, Open-labelled, Randomized, Multicenter Phase II Study to Evaluate Efficacy and Safety of Erlotinib vs NP Chemotherapy as Adjuvant Therapy in Post Radical Operation NSCLC Patients With EGFR19 or 21 Exon Mutation [NCT01683175]Phase 294 participants (Actual)Interventional2012-08-31Active, not recruiting
An Open Label Phase I Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Carboplatin and Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer - Stage IV [NCT01683682]Phase 18 participants (Actual)Interventional2013-04-30Completed
An Open Label Phase I Dose Escalation Trial of Oral BIBF 1120 in Combination With Intravenous Vinorelbine in Elderly Patients With Advanced Non Small Lung Cell Cancer - Stage IV [NCT01684111]Phase 17 participants (Actual)Interventional2013-06-30Completed
A Randomized Phase III Trial of Vinorelbine Versus Gemcitabine and Carboplatin for Elderly Patients With Advanced Non-Small Cell Lung Cancer [NCT00265694]Phase 30 participants InterventionalRecruiting
Phase II Clinical Trial With the Combination Gemcitabine, Oxaliplatin and Vinorelbine as First Line Treatment in Patients With Non-small Cell Bronchopulmonary Cancer [NCT00271271]Phase 240 participants Interventional2003-06-30Completed
Phase II Study of Carboplatin and Vinorelbine i.v. (Day 1) and Orally (Day 8) for Malignant Pleural Mesothelioma [NCT00272558]Phase 240 participants (Anticipated)Interventional2004-09-30Completed
A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer [NCT00287963]Phase 118 participants (Actual)Interventional2004-02-29Completed
Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in Subjects With Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) Who Have Failed at Lea [NCT03901339]Phase 3543 participants (Actual)Interventional2019-05-08Completed
Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib) [NCT00298415]Phase 3451 participants (Actual)Interventional2006-03-31Completed
A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSAâ„¢) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer [NCT00333294]Phase 250 participants Interventional2004-09-30Completed
A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Can [NCT00453635]Phase 288 participants (Actual)Interventional2003-12-31Terminated(stopped due to Due to poor accrual)
Vinorelbine Plus Bevacizumab as First Line Therapy in Patients ≥ 70 Years of Age With Stage IIIB/IV Non-Squamous, Non-Small Cell Lung Cancer [NCT00309998]Phase 250 participants (Anticipated)Interventional2005-09-30Completed
Adjuvant Chemotherapy With Pemetrexed and Cisplatin vs. Vinorelbine and Cisplatin in NSCLC IB, IIA, IIB, T3N1: a Randomized Phase II Study [NCT00349089]Phase 2132 participants (Actual)Interventional2006-09-26Completed
A Phase 2 Multi-Center Randomized Trial to Assess Early Intervention With Adjuvant Nivolumab in Non-Small Cell Lung Cancer Participants With ctDNA-detected Minimal Residual Disease After Surgical Resection [NCT03770299]Phase 20 participants (Actual)Interventional2021-01-15Withdrawn(stopped due to Business objectives have changed)
Phase II Individualized Therapies Selection Study for Patients With Metastatic Colorectal Carcinoma According to the Genomic Expression Profile in Tumor Samples. [NCT01703910]Phase 229 participants (Actual)Interventional2012-11-30Completed
Randomized Phase II Study of Lapatinib Plus Vinorelbine Versus Vinorelbine in Patients With HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib and Trastuzumab Treatment [NCT01730677]Phase 2150 participants (Anticipated)Interventional2012-07-31Recruiting
Combination Followed by Maintenance Chemotherapy Versus CDK4/6 Inhibitor Combined With Endocrine Therapy for HR Low/HER2-negative Advanced Breast Cancer: a Prospective, Randomized, Open-label Phase â…¡ Clinical Trial [NCT06176534]Phase 2240 participants (Anticipated)Interventional2023-12-20Not yet recruiting
A Phase â…¡ Single-arm Clinical Trial to Investigate the Efficacy and Safety of Vinorelbine-ifosfamide Regimen as Third-line Treatment in Refractory or Recurrent Extensive Small Cell Lung Cancer Patients [NCT01752517]60 participants (Anticipated)Observational2012-12-31Recruiting
Randomized Double-blind Controlled Clinical Study of Chemotherapy Combined With or Without Traditional Chinese Medicine on Survival Affect of Elderly Patients With Advanced Non-small-cell Lung Cancer [NCT01780181]82 participants (Actual)Observational2012-12-31Completed
A Multi-center Phase II Randomized Study of Customized Neoadjuvant Therapy Versus Standard Chemotherapy in Non-small Cell Lung Cancer (NSLC) Patients With Resectable Stage IIIA (N2) Disease (CONTEST-TRIAL) [NCT01784549]Phase 2168 participants (Anticipated)Interventional2012-07-31Recruiting
Pilot Safety and Blood Immune Cell Transcriptional Profiling Study of Anakinra Plus the Physician's Chemotherapy Choice in Metastatic Breast Cancer Patients [NCT01802970]Phase 110 participants (Actual)Interventional2012-12-31Completed
Randomized, Controlled, Multicenter Study of Neoadjuvant Therapy With Icotinib in IIIA NSCLC Patients With Epidermal Growth Factor Receptor Mutation [NCT01843647]Phase 2100 participants (Anticipated)Interventional2013-04-30Recruiting
Phase 2 Study of Weekly Vinorelbine in Children With Progressive or Recurrent Low-Grade Gliomas [NCT01497860]Phase 213 participants (Actual)Interventional2011-07-31Completed
Using PERS(PErsonalized Regimen Selection) Genetic Model Assistant Decision-making System of Neoadjuvant Chemotherapy for Breast Cancer Multicentric, Prospective, Randomized Controlled Phase III Clinical Study [NCT03006614]Phase 3320 participants (Anticipated)Interventional2016-04-30Recruiting
A Prospective Phase â…¡ Clinical Study of Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer That Has Failed Trastuzumab Therapy [NCT04903652]Phase 230 participants (Actual)Interventional2021-01-01Completed
Phase II Trial of Neoadjuvant Platinum-based Chemotherapy for Patients With Resectable , Non-small Cell Lung Cancer With Switch to Chemotherapy Alternative in Nonresponders (NEOSCAN) [NCT01443078]Phase 242 participants (Actual)Interventional2011-10-31Completed
Phase II Study to Evaluate the Role of Postoperative Radiotherapy for Low Risk of Locoregional Recurrence Patients With Completely Resected Stage IIIA(N2) Non-Small Cell Lung Cancer [NCT02977169]Phase 2300 participants (Anticipated)Interventional2016-11-30Recruiting
Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator's Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based [NCT01441596]Phase 2121 participants (Actual)Interventional2011-10-31Completed
A Phase III Prospective Randomized Study of Adjuvant Chemotherapy With Vinorelbine and Cisplatin in Completely Resected Non-Small Cell Lung Cancer With Companion Tumour Marker Evaluation [NCT00002583]Phase 3482 participants (Actual)Interventional1994-07-07Completed
GVD±R (Gemcitabine, Oral Vinorelbine and Doxorubicin Liposome, With or Without Rituximab) Regimen for Autologous Hematopoietic Stem Cell Transplantation(ASCT)-Eligible Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma:a Multi-center, Single [NCT04021992]Phase 248 participants (Anticipated)Interventional2019-07-15Recruiting
Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Carboplatin Versus Gemcitabine Plus Carboplatin [NCT04143906]Phase 2200 participants (Anticipated)Interventional2019-10-25Not yet recruiting
An Open-Label Randomized Phase II Study of Cipterbin® or Cipterbin® in Combination With Vinorelbine in Patients With HER2/Neu-overexpressed Metastatic Breast Cancer (MBC) [NCT01439191]Phase 2109 participants (Actual)Interventional2005-07-31Completed
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Che [NCT05104866]Phase 3733 participants (Actual)Interventional2021-10-18Active, not recruiting
Phase â…¡Trial of S1 Capsule Plus Cisplatin Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage â…¡-â…¢A Non-small Cell Lung Cancer (NSCLC) After Complete Resection [NCT02223611]Phase 2100 participants (Anticipated)Interventional2014-12-31Not yet recruiting
DETECT V / CHEVENDO A Multicenter, Randomized Phase III Study to Compare Chemo- Versus Endocrine Therapy in Combination With Dual HER2-targeted Therapy of Herceptin® (Trastuzumab) and Perjeta® (Pertuzumab) Plus Kisqali® (Ribociclib) in Patients With HER2 [NCT02344472]Phase 3270 participants (Anticipated)Interventional2015-09-30Recruiting
High Dose Chemotherapy With Stem Cell Rescue Followed By Consolidation Treatment in Patients With Metastatic Hormone-Refractory Prostate Cancer [NCT00003400]Phase 245 participants (Anticipated)Interventional1998-09-30Completed
Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer [NCT00003622]Phase 20 participants (Actual)Interventional1999-01-31Withdrawn(stopped due to No recruitment)
A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast Cancer [NCT00003730]80 participants (Anticipated)Interventional1998-12-31Completed
FaR-RMS: An Overarching Study for Children and Adults With Frontline and Relapsed RhabdoMyoSarcoma [NCT04625907]Phase 1/Phase 21,672 participants (Anticipated)Interventional2020-09-17Recruiting
Durvalumab (MEDI4736) in Frail and Elder Patients With Metastatic NSCLC (DURATION) [NCT03345810]Phase 2200 participants (Actual)Interventional2017-12-14Completed
Adjuvant Toripalimab Versus Placebo Combined With Chemotherapy for EGFR/ALK Mutation Negative Stage II-IIIB(N2) Non-small-cell Lung Cancer (LungMate-008): a Randomised, Double-blind, Controlled, Phase 3 Trial [NCT04772287]Phase 3341 participants (Anticipated)Interventional2021-03-31Not yet recruiting
A Study of Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel as Neoadjuvant Therapy for Resectable, Hormone Receptor Negative or Hormone Receptor Positive, HER-2/Neu Positive Breast Cancer Followed by a Novel Regi [NCT00194779]Phase 250 participants (Actual)Interventional2003-10-31Completed
Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201 [NCT00088985]Phase 256 participants (Actual)Interventional2004-01-31Terminated(stopped due to Funding unavailable)
Safety and Efficacy of Metronomic Vinorelbine in Combination With Toripalimab for Patients With HER2- Metastatic Breast Cancer [NCT04389073]Phase 2138 participants (Anticipated)Interventional2020-04-01Recruiting
QL1706 Combined With Platinum-based Chemotherapy Versus Placebo Combined With Platinum-based Chemotherapy as Adjuvant Therapy for Stage II-IIIB Non-small Cell Lung Cancer After Complete Surgical Resection: a Randomized, Double-blind, Multicenter Phase III [NCT05487391]Phase 3632 participants (Anticipated)Interventional2022-10-01Not yet recruiting
A Phase II Study of RRx-001 in Platinum Refractory/Resistant Small Cell Carcinoma, EGFR TKI Resistant EGFR+ T790M Negative Non-Small Cell Lung Cancer, High Grade Neuroendocrine Tumors and Resistant/Refractory Ovarian Cancer Prior to Re-administration of P [NCT02489903]Phase 2139 participants (Actual)Interventional2015-06-30Completed
Phase I/II Vinorelbine and Sorafenib as Salvage Therapy in Metastatic Breast Cancer [NCT00828074]Phase 1/Phase 246 participants (Actual)Interventional2008-11-30Completed
A Phase III Clinical Trial of Docetaxel Plus Cisplatin Versus Vinorelbine Plus Cisplatin in Neoadjuvant Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma [NCT02465736]Phase 3610 participants (Anticipated)Interventional2015-07-31Recruiting
A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer [NCT00148668]Phase 281 participants (Actual)Interventional2003-12-31Completed
[NCT00433095]Phase 20 participants InterventionalCompleted
Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Inhibitor Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer (PRaG 6.0) [NCT05603013]Phase 245 participants (Anticipated)Interventional2022-10-30Not yet recruiting
A Phase II Safety and Tolerability Study of Avastin When Added to Single-agent Chemotherapy to Treat Patient With Breast Cancer Metastatic to Brain [NCT00476827]Phase 216 participants (Actual)Interventional2007-05-31Terminated(stopped due to Slow accrual)
A Phase II Trial of Combination Vinorelbine-Estramustine With or Without Prednisone for High Risk and Recurrent, Advanced and Metastatic Renal Cell Carcinoma [NCT00003584]Phase 235 participants (Anticipated)Interventional1998-07-31Completed
Gemcitabine and Vinorelbine vs Standard Chemotherapy Containing Cisplatin for Stage IIIB/IV Non-Small Cell Lung Cancer [NCT00004100]Phase 30 participants Interventional1998-11-30Active, not recruiting
Phase I/II of Capecitabine and Vinorelbine in Elderly Patients (At Least 65 Years) With Metastatic Breast Cancer With or Without Bone Involvement [NCT00003902]Phase 1/Phase 2110 participants (Anticipated)Interventional1999-03-31Completed
PHASE I TRIAL OF HYDROXYUREA FOR SALVAGE OF INCURABLE NON-SMALL CELL LUNG CANCER [NCT00002887]Phase 130 participants (Anticipated)Interventional1995-07-31Active, not recruiting
A Phase I/II Study of Paclitaxel, Estramustine Phosphate, and Vinorelbine (PaclEVin) [NCT00004105]Phase 1/Phase 20 participants Interventional1998-09-30Completed
A Randomized Phase II Trial of Navelbine/Epirubicin Versus Navelbine/Mitozantrone Versus Cyclophosphamide/Adriamycin as Preoperative Chemotherapy in Patients With > or = 3cm Diameter Early Breast Cancer [NCT00004237]Phase 20 participants Interventional1998-10-31Completed
Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine [NCT00003259]Phase 240 participants (Anticipated)Interventional1997-10-31Completed
A Protocol For Nonmetastatic Rhabdomyosarcoma [RMS-2005] [NCT00379457]Phase 3600 participants (Anticipated)Interventional2006-06-30Recruiting
Phase I Study of Concomitant Chemoradiotherapy With Vinorelbine and Paclitaxel in Patients With Advanced Pelvic Malignancies [NCT00002949]Phase 133 participants (Actual)Interventional1996-07-31Completed
A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and C [NCT02915744]Phase 3178 participants (Actual)Interventional2016-11-30Completed
Randomized Trial of Surgical Resection With or Without Pre-Operative Chemotherapy in Patients With Operable Non-Small Cell Lung Cancer (NSCLC) of Any Stage [NCT00003159]Phase 3600 participants (Anticipated)Interventional1997-08-31Completed
A Phase II Study of Metronomic Oral Chemotherapy With Cyclophosphamide Plus Capecitabine and Vinorelbine in Metastatic Breast Cancer Patients [NCT04304352]Phase 2162 participants (Anticipated)Interventional2011-07-29Recruiting
A LARGE-SCALE TRIAL EVALUATING ADJUVANT CHEMOTHERAPY AFTER CURATIVE RESECTION OF NON-SMALL CELL LUNG CANCER [NCT00002823]Phase 33,300 participants (Anticipated)Interventional1995-02-28Completed
Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination [NCT00003963]Phase 214 participants (Actual)Interventional1999-05-31Completed
Phase II Study of Pyrotinib and Vinorelbine Tartrate Capsules With or Without Inetetamab for First Line Treatment in Patients With Trastuzumab-resistant HER2-positive Advanced Breast Cancer [NCT04963595]Phase 2100 participants (Anticipated)Interventional2021-08-01Not yet recruiting
Open-label Trial of Imatinib in Combination With Vinorelbine for Patients With Advanced Breast Carcinoma: ICON [NCT00372476]Phase 433 participants (Actual)Interventional2006-06-30Completed
A Two-cohort, Open-label, Multicenter Phase II Trial Assessing the Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in First Line Patients With HER2-positive Advanced (Metastatic or Locally Advanced) Breast Cancer [NCT01565083]Phase 2213 participants (Actual)Interventional2012-04-30Completed
Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma [NCT03397953]Phase 220 participants (Anticipated)Interventional2016-11-30Completed
Phase II Study of Intravenous Vinorelbine in Patients With Relapsed Platinum Resistant or Refractory C5 High Grade Serous, Endometrioid, or Undifferentiated Primary Peritoneum, Fallopian Tube or Ovarian Cancer (VIP) [NCT03188159]Phase 236 participants (Anticipated)Interventional2017-07-01Recruiting
A Phase Ib/II Study of Pembrolizumab Plus Chemotherapy in Patients With Advanced Cancer (PembroPlus) [NCT02331251]Phase 1/Phase 281 participants (Actual)Interventional2014-12-31Terminated(stopped due to PI not longer at site.)
A Randomized Phase II Trial Comparing Stem Cell Mobilization With Chemotherapy and Cytokine (G-CSF) Versus Cytokine (G-CSF) Alone in Myeloma Patients (MOCCCA-trial). [NCT03442673]Phase 2137 participants (Actual)Interventional2018-09-17Active, not recruiting
Icotinib as Adjuvant Therapy Compared With Standard Chemotherapy in Stage II-IIIA Non-small Cell Lung Cancer With EGFR-mutation: a Randomized, Positive-controlled, Phase 3 Study (EVIDENCE, CCTC-1501) [NCT02448797]Phase 3320 participants (Anticipated)Interventional2015-06-08Active, not recruiting
A Multi-center, Randomized, Open-label Study on Pharmacokinetics, Safety, Efficacy, and Immunogenicity of Cipterbin Combined With Vinorelbine Injection Every Week or Every Three Weeks in the Treatment of Patients With HER2-positive Metastatic Breast Cance [NCT05131841]Phase 460 participants (Anticipated)Interventional2021-01-04Recruiting
"Single Arm Phase II Study of the Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non-resectable Locally Advanced or Metastatic Breast Cancer TrasTUCAN Study" [NCT05583110]Phase 249 participants (Anticipated)Interventional2023-03-08Recruiting
Induction Chemotherapy With Carboplatin and Navelbine Oral(R) Followed by Concomitant Navelbine Oral(R) and Irradiation in Local-regionally Advanced Non-small Cell Lung Cancer. A Randomized Phase II Study. [NCT00887783]Phase 2117 participants (Actual)Interventional2009-05-01Completed
[NCT01454934]Phase 3540 participants (Actual)Interventional2011-12-09Completed
A Randomized Phase II Trial of Mitoxantrone, Estramustine and Navelbine or 13-cis Retinoic Acid, Interferon and Paclitaxel in Patients With Metatstatic Hormone Refractory Prostate Cancer [NCT00005847]Phase 20 participants Interventional2001-04-05Completed
Phase II Study on the Use of Molecular Analyses-Based Customized Chemotherapy in Patients With Stage IV/IIIB (Malignant Pleural Effusion) Non-Small-Cell Lung Cancer (NSCLC) [NCT00215930]Phase 253 participants (Actual)Interventional2004-02-29Completed
A Phase II Study of Cisplatin With Intravenous and Oral Vinorelbine as Induction Chemotherapy Followed by Concomitant Chemotherapy With Oral Vinorelbine and Cisplatine for Locally Advances Non-small Cell Lung Cancer [NCT01839032]Phase 270 participants (Actual)Interventional2005-05-31Completed
Phase II Study of Vinorelbine for Children With Recurrent Anaplastic Large Cell Lymphoma [NCT03443128]Phase 220 participants (Anticipated)Interventional2016-11-30Recruiting
Phase II Trial Evaluating the Toxicity and Efficacy of a Multiepitope Dendritic Cell Vaccine Given With Trastuzumab and Vinorelbine Ditartrate for the Treatment of Women With Metastatic Breast Cancer That Express HLA-A0201 and Whose Tumors Overexpress HER [NCT00266110]Phase 217 participants (Actual)Interventional2005-12-31Completed
Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC. [NCT00148798]Phase 31,861 participants (Actual)Interventional2004-10-31Completed
Pilot Pharmacokinetic Study of Dose Adjustment of Vinorelbine in Patients With Varying Degree of Liver Dysfunction [NCT00540982]Phase 1/Phase 247 participants (Actual)Interventional1996-12-31Completed
An Intention-to-Treat Study of Salvage Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplant for the Treatment of High-Risk or Relapsed Hodgkin Lymphoma [NCT00574496]Phase 225 participants (Actual)Interventional2007-11-13Completed
A Randomized Phase II Trial of Pertuzumab in Combination With Trastuzumab With or Without Chemotherapy, Both Followed by T-DM1 in Case of Progression, in Patients With HER2-positive Metastatic Breast Cancer [NCT01835236]Phase 2208 participants (Actual)Interventional2013-03-03Completed
Phase 2 Study of MCLA-128-based Combinations in Metastatic Breast Cancer (MBC): MCLA-128/Trastuzumab/Chemotherapy in HER2-positive MBC and MCLA-128/Endocrine Therapy in Estrogen Receptor Positive and Low HER2 Expression MBC [NCT03321981]Phase 2101 participants (Actual)Interventional2018-01-15Active, not recruiting
Randomized Phase II Trial of Chemotherapy of Physician's Choice Plus Trastuzumab Versus Chemotherapy of Physician's Choice Plus Trastuzumab Plus Pertuzumab In Women With Pretreated, HER2-Overexpressing Metastatic Breast Cancer (MBC) [NCT02229149]Phase 233 participants (Actual)Interventional2014-12-31Terminated(stopped due to per Sponsor request)
A LIMITED ACCESS PHASE II TRIAL OF CISPLATIN AND NAVELBINE (VINORELBINE) IN ADVANCED AND RECURRENT SQUAMOUS CELL CARCINOMA OF THE CERVIX [NCT00002813]Phase 262 participants (Anticipated)Interventional1997-08-31Completed
Randomized Phase II Trial of Carboplatin/Gemcitabine Followed By Paclitaxel or Cisplatin/Vinorelbine Followed by Docetaxel in Advanced Non-Small Cell Lung Cancer [NCT00003587]Phase 2204 participants (Actual)Interventional1998-10-31Completed
A Phase I Dose Escalation/Expansion Clinical Trial of Mocetinostat in Combination With Vinorelbine in Children, Adolescents and Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma (RMS) [NCT04299113]Phase 138 participants (Anticipated)Interventional2020-05-14Recruiting
A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin vs Investigator's Choice Chemotherapy in Second- or Third-Line Recurrent or Metastatic Cervical Cancer [NCT04697628]Phase 3556 participants (Anticipated)Interventional2021-02-22Recruiting
A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303cversus Trastuzumab Combined With Vinorelbine/Capecitabine in of HER2-positive Advanced Breast Cancer [NCT05901935]Phase 3420 participants (Anticipated)Interventional2023-07-31Not yet recruiting
Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxaneâ„¢) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer [NCT00503750]Phase 227 participants (Actual)Interventional2008-04-30Completed
Phase 2 Study of Bevacizumab in Combination With Vinorelbine and Trastuzumab for HER2-Positive, Metastatic Breast Cancer [NCT00670982]Phase 229 participants (Actual)Interventional2008-05-31Completed
Neoadjuvant Soft Tissue Ablation Utilizing Aliyaâ„¢ Pulsed Electric Fields With Systemic Therapy in Early-Stage Resectable Non-Small Cell Lung Cancer (NSCLC) [NCT05583188]Phase 415 participants (Anticipated)Interventional2023-02-01Recruiting
A Phase III, Randomized, Multi-center Study to Determine the Efficacy of the Intercalating Combination Treatment of Chemotherapy and Gefitinib or Chemotherapy as Adjuvant Treatment in NSCLC With Common EGFR Mutations. [NCT03381066]Phase 3225 participants (Anticipated)Interventional2018-04-10Recruiting
A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib Plus Oral Vinorelbine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer [NCT05823623]Phase 230 participants (Anticipated)Interventional2022-02-13Recruiting
A Doublelet Metronomic Chemotherapeutic Regimen With Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer Patients: A Monocentric Retrospective Study in China [NCT05747326]Phase 230 participants (Anticipated)Interventional2022-01-01Recruiting
A Randomized Phase II Trial of Metronomic Oral Vinorelbine Plus Cyclophosphamide and Capecitabine (VEX) Versus Weekly Paclitaxel as First-line or Second-line Treatment in Patients With ER-positive/HER2-negative Advanced or Metastatic Breast Cancer [NCT02954055]Phase 2140 participants (Actual)Interventional2017-09-13Active, not recruiting
Randomized, Phase II Study With Gefitinib Plus Vinorelbine Versus Gefitinib Alone in Patients Affected by Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of EGFR [NCT02319577]Phase 280 participants (Anticipated)Interventional2012-03-31Recruiting
An Open-Label, Multicenter, Phase II Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa (RO6874281), an Immunocytokine, Consisting of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), in Combination With Atezolizum [NCT03386721]Phase 2256 participants (Actual)Interventional2018-02-19Terminated(stopped due to The Sponsor discontinued the development of Simlukafusp alfa due to portfolio prioritization, not due to any safety, efficacy, or quality issues.)
Randomized Phase II Trial of Pemetrexed Plus Vinorelbine Versus Vinorelbine in Patients With Recurrent or Metastatic Breast Cancer Previously Treated With or Resistant to Anthracycline and Taxane [NCT03242616]Phase 2125 participants (Anticipated)Interventional2017-02-17Recruiting
A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119) [NCT02555657]Phase 3622 participants (Actual)Interventional2015-10-13Completed
A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab Compared With Chemotherapy in Patients With Treatment Naïve Advanced or Recurrent (Stage IIIb Not Amenable for Multimodality Treatment) or Metast [NCT03191786]Phase 3453 participants (Actual)Interventional2017-09-11Completed
A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS) [NCT02567435]Phase 3321 participants (Actual)Interventional2016-06-01Active, not recruiting
A Phase I/II Study to Evaluate the Safety and Efficacy of Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer [NCT02658084]Phase 1/Phase 22 participants (Actual)Interventional2017-04-12Terminated(stopped due to Terminated due to low accrual and toxicity concerns.)
A Phase 2, Multicenter, Randomized Study to Evaluate the Safety and Efficacy of Viagenpumatucel-L (HS-110) in Combination With Low Dose (Metronomic) Cyclophosphamide Versus Chemotherapy Alone in Patients With Non-Small Cell Lung Adenocarcinoma After Failu [NCT02117024]Phase 266 participants (Actual)Interventional2014-07-31Terminated(stopped due to Sponsor Decision; strategic - based on changing treatment landscape)
PERSONALIZED MEDICINE GROUP / UCBG UC-0105/1304: SAFIR02_Breast - Evaluation of the Efficacy of High Throughput Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer [NCT02299999]Phase 21,460 participants (Actual)Interventional2014-04-07Active, not recruiting
Phase III Study to Evaluate the Optimal Timing of Postoperative Radiotherapy for High Risk of Locoregional Recurrence Patients With Completely Resected Stage IIIA(N2) Non-Small Cell Lung Cancer [NCT02974426]Phase 31,094 participants (Anticipated)Interventional2016-11-30Recruiting
Open Label Phase II Trial to Evaluate Safety and Efficacy of Vinorelbine With Metronomic Administration in Combination With Atezolizumab as Second-line Treatment for Patients With Stage IV Non-small Cell Lung Cancer [NCT03801304]Phase 280 participants (Actual)Interventional2019-01-24Completed
A Phase II With 2 Parallel Cohorts Clinical Trial Targeting Estrogen Receptor Negative or PAM50 Non-luminal Disease With Atezolizumab in Combination With Trastuzumab and Vinorelbine in HER2-positive Advanced/Metastatic Breast Cancer - ATREZZO Study [NCT04759248]Phase 255 participants (Anticipated)Interventional2021-03-15Recruiting
Expanded Access Protocol With ABT-888 (Veliparib) in Patients With Metastatic BRCA-Mutation Associated or Triple Negative Breast Cancer [NCT02985658]0 participants Expanded AccessNo longer available
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00026494 (1) [back to overview]Radiographic Response Assessed by Macdonald Criteria Every 2 Months
NCT00041067 (4) [back to overview]Progression-free Survival
NCT00041067 (4) [back to overview]Toxicity
NCT00041067 (4) [back to overview]Response Rate (Complete and Partial, Confirmed and Unconfirmed)
NCT00041067 (4) [back to overview]Survival at 1 Year
NCT00041470 (1) [back to overview]To Measure the Qualitative and Quantitative Toxicity of This Regimen.
NCT00064077 (5) [back to overview]Duration of Overall Survival (OS)
NCT00064077 (5) [back to overview]Duration of Progression-free Survival (PFS)
NCT00064077 (5) [back to overview]Pain, Assessed by Brief Pain Inventory
NCT00064077 (5) [back to overview]Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).
NCT00064077 (5) [back to overview]Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)
NCT00088530 (4) [back to overview]Overall Survival
NCT00088530 (4) [back to overview]Progression-Free Survival (PFS)
NCT00088530 (4) [back to overview]Complete Response (CR) and Complete Response Unconfirmed (CRu)
NCT00088530 (4) [back to overview]Overall Response Rate (ORR) Lasting at Least 4 Months
NCT00088985 (1) [back to overview]Overall Response Rate
NCT00093808 (4) [back to overview]Overall Survival as Assessed by Time
NCT00093808 (4) [back to overview]Duration of Response as Measured by RECIST Criteria
NCT00093808 (4) [back to overview]Confirmed Response Rate
NCT00093808 (4) [back to overview]Time to Progression (TTP)
NCT00140140 (11) [back to overview]Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count
NCT00140140 (11) [back to overview]Kaplan-Meier Estimates for Participant Survival
NCT00140140 (11) [back to overview]Participants With Dose Limiting Toxicities
NCT00140140 (11) [back to overview]Kaplan Meier Estimate for Progression-Free Survival (PFS)
NCT00140140 (11) [back to overview]Kaplan Meier Estimate for Time to Disease Progression (TTP)
NCT00140140 (11) [back to overview]Nadir Measurement for Hemoglobin (Hgb)
NCT00140140 (11) [back to overview]Kaplan-Meier Estimate for Duration of Response
NCT00140140 (11) [back to overview]Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)
NCT00140140 (11) [back to overview]Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)
NCT00140140 (11) [back to overview]Percentage of Participants With Discontinued, Delayed or Interrupted Therapy
NCT00140140 (11) [back to overview]Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)
NCT00148668 (1) [back to overview]Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer
NCT00148798 (8) [back to overview]Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
NCT00148798 (8) [back to overview]Safety - Number of Patients Experiencing Any Adverse Event
NCT00148798 (8) [back to overview]Disease Control Rate
NCT00148798 (8) [back to overview]Best Overall Response Rate
NCT00148798 (8) [back to overview]Progression-free Survival Time
NCT00148798 (8) [back to overview]Overall Survival Time (OS)
NCT00148798 (8) [back to overview]A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations
NCT00148798 (8) [back to overview]Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
NCT00169104 (4) [back to overview]Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Chemotherapy, Trastuzumab, and G-CSF Against a Her-2 Overexpressing Target in Vitro
NCT00169104 (4) [back to overview]Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Trastuzumab With Either G-CSF or a Saline Placebo Against a Her-2 Overexpressing Target in Vitro
NCT00169104 (4) [back to overview]Safety of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer
NCT00169104 (4) [back to overview]Clinical Response Rate of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer
NCT00194779 (6) [back to overview]Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation
NCT00194779 (6) [back to overview]Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy
NCT00194779 (6) [back to overview]Time to Progression
NCT00194779 (6) [back to overview]Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)
NCT00194779 (6) [back to overview]OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN
NCT00194779 (6) [back to overview]Disease-free Survival
NCT00194792 (6) [back to overview]Overall Survival
NCT00194792 (6) [back to overview]Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation
NCT00194792 (6) [back to overview]Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities
NCT00194792 (6) [back to overview]Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response
NCT00194792 (6) [back to overview]Number of Participants With Clinical Response
NCT00194792 (6) [back to overview]Disease-free Survival
NCT00215930 (3) [back to overview]Best Disease Response After a Maximum of Six Cycles.
NCT00215930 (3) [back to overview]Progression Free Survival (PFS)
NCT00215930 (3) [back to overview]Overall Survival (OS)
NCT00256282 (2) [back to overview]Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy
NCT00256282 (2) [back to overview]Percentage of Patients Alive at One Year
NCT00266110 (3) [back to overview]Number of Participants With Response
NCT00266110 (3) [back to overview]Generation of Interferon Gamma Positive CD8+T Cells
NCT00266110 (3) [back to overview]Generation of E75/E90 Tetramer-positive CD8+ T Cells
NCT00302003 (4) [back to overview]Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
NCT00302003 (4) [back to overview]Intensive Therapy Free Survival (ITFS).
NCT00302003 (4) [back to overview]Overall Survival
NCT00302003 (4) [back to overview]Event Free Survival (EFS)
NCT00324805 (2) [back to overview]Overall Survival
NCT00324805 (2) [back to overview]Disease-free Survival
NCT00325234 (6) [back to overview]Time to Response
NCT00325234 (6) [back to overview]Duration of Response (DOR)
NCT00325234 (6) [back to overview]Time to Progressive Disease (PD)
NCT00325234 (6) [back to overview]Time To Treatment Failure (TTTF)
NCT00325234 (6) [back to overview]Number of Participants With Adverse Events (AE)
NCT00325234 (6) [back to overview]Tumor Response Rate
NCT00337194 (6) [back to overview]Event Free Survival (EFS)
NCT00337194 (6) [back to overview]Number of Participants With Overall Response (OR)
NCT00337194 (6) [back to overview]Overall Survival (OS) At 1 Year
NCT00337194 (6) [back to overview]Peak Serum Level of Monoclonal Antibody SGN-30
NCT00337194 (6) [back to overview]sCD30 Levels
NCT00337194 (6) [back to overview]Fc Gamma Receptor Polymorphisms
NCT00381940 (5) [back to overview]Number of Participants With Grade 3 or 4 Toxicity
NCT00381940 (5) [back to overview]Rate of Successful PBSC Harvest
NCT00381940 (5) [back to overview]Complete Response (CR)
NCT00381940 (5) [back to overview]Induction Success Rate
NCT00381940 (5) [back to overview]Overall Response Rate
NCT00388349 (5) [back to overview]Survival Measures
NCT00388349 (5) [back to overview]Relapse Post-transplant
NCT00388349 (5) [back to overview]Pulmonary Toxicity (BCNU Pneumonitis)
NCT00388349 (5) [back to overview]Overall Survival (OS)
NCT00388349 (5) [back to overview]Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity
NCT00391586 (1) [back to overview]Toxicity Profile
NCT00432562 (10) [back to overview]Last Quantifiable Drug Concentration (Clast)
NCT00432562 (10) [back to overview]Maximum Observed Plasma Concentration (Cmax)
NCT00432562 (10) [back to overview]Mean Residence Time (MRTinf)
NCT00432562 (10) [back to overview]Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)
NCT00432562 (10) [back to overview]Observed Terminal Elimination Half-Life (t1/2)
NCT00432562 (10) [back to overview]Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)
NCT00432562 (10) [back to overview]Percentage of AUCinf Based on Extrapolation (AUCextrap)
NCT00432562 (10) [back to overview]Time of Last Measurable Concentration (Tlast)
NCT00432562 (10) [back to overview]Time to Reach Maximum Observed Plasma Concentration (Tmax)
NCT00432562 (10) [back to overview]Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)
NCT00499109 (3) [back to overview]Response Rate (RR)
NCT00499109 (3) [back to overview]Overall Survival (OS)
NCT00499109 (3) [back to overview]Progression Free Survival (PFS)
NCT00503750 (2) [back to overview]Number of Participants With Complete Pathologic Response.
NCT00503750 (2) [back to overview]Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.
NCT00540982 (2) [back to overview]Area Under the Curve
NCT00540982 (2) [back to overview]Number of Participants With Grade 3 and 4 Toxicities
NCT00545948 (3) [back to overview]2-Year Overall Survival in Patients Treated for NSCLC
NCT00545948 (3) [back to overview]Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy
NCT00545948 (3) [back to overview]2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC
NCT00574496 (3) [back to overview]Disease Relapse or Progression as Measured by CT Scan or PET
NCT00574496 (3) [back to overview]Overall Survival
NCT00574496 (3) [back to overview]Progression-free Survival at 1 Year
NCT00597116 (4) [back to overview]Progression-free Survival (PFS)
NCT00597116 (4) [back to overview]Overall Survival (OS)
NCT00597116 (4) [back to overview]Number of Participants With Objective Response.
NCT00597116 (4) [back to overview]Number of Participants With Disease Control.
NCT00602797 (3) [back to overview]Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events
NCT00602797 (3) [back to overview]Progression-free Survival.
NCT00602797 (3) [back to overview]Response Rate Based on RECIST Criteria
NCT00632827 (4) [back to overview]Progression Free Survival
NCT00632827 (4) [back to overview]Complete Response Rate
NCT00632827 (4) [back to overview]Median Time to Response
NCT00632827 (4) [back to overview]Overall Survival Rate
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 4
NCT00659269 (4) [back to overview]Change in Neurotoxicity Assessment Between Cycle 4 and Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Baseline
NCT00659269 (4) [back to overview]Neurotoxicity Assessment at Cycle 2
NCT00670982 (3) [back to overview]Progression-free Survival
NCT00670982 (3) [back to overview]Objective Response Rate
NCT00670982 (3) [back to overview]Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.
NCT00675597 (1) [back to overview]To Measure the Number of Cycles
NCT00686959 (7) [back to overview]First Site of Disease Failure in Terms of Relapse
NCT00686959 (7) [back to overview]Adverse Events: The Number of Deaths Per Treatment Group
NCT00686959 (7) [back to overview]Percentage of Participants With a Post Baseline Swallowing Diary Score >=4
NCT00686959 (7) [back to overview]Progression-free Survival (PFS)
NCT00686959 (7) [back to overview]Survival Rates at 1, 2, and 3 Years
NCT00686959 (7) [back to overview]Objective Response Rate (Complete Response [CR] + Partial Response [PR])
NCT00686959 (7) [back to overview]Overall Survival
NCT00706030 (5) [back to overview]Duration Of Response
NCT00706030 (5) [back to overview]Maximum Tolerated Dose
NCT00706030 (5) [back to overview]Overall Response Rate
NCT00706030 (5) [back to overview]Progression-Free Survival
NCT00706030 (5) [back to overview]Clinical Benefit Rate
NCT00709618 (6) [back to overview]Duration of Response, as Assessed by the Investigator
NCT00709618 (6) [back to overview]Number of Participants With Overall Response (OR), as Assessed by the Investigator
NCT00709618 (6) [back to overview]Progression-Free Survival (PFS), as Assessed by the Investigator
NCT00709618 (6) [back to overview]Time to Progression (TTP), as Assessed by the Investigator
NCT00709618 (6) [back to overview]Time to Response, as Assessed by the Investigator
NCT00709618 (6) [back to overview]Number of Participants With the Indicated Adverse Events Occurring in at Least 5 Participants and Related to the Combination of Lapatinib and Vinorelbine
NCT00828074 (7) [back to overview]Objective Response Rate
NCT00828074 (7) [back to overview]Overall Survival
NCT00828074 (7) [back to overview]Progression-free Survival
NCT00828074 (7) [back to overview]Progression-free Survival Rate at 4 Months
NCT00828074 (7) [back to overview]Recommended Phase II Dose
NCT00828074 (7) [back to overview]Toxicity Profile
NCT00828074 (7) [back to overview]Number of Participants With at Least One Dose Limiting Toxicity in Phase I
NCT00842712 (6) [back to overview]Randomized Part: Best Overall Response (BOR) Rate
NCT00842712 (6) [back to overview]Randomized Part: Overall Survival (OS) Time
NCT00842712 (6) [back to overview]Randomized Part: Progression Free Survival (PFS) Time - Independent Read
NCT00842712 (6) [back to overview]Randomized Part: Progression Free Survival (PFS) Time - Investigator Read
NCT00842712 (6) [back to overview]Randomized Part: Time to Treatment Failure
NCT00842712 (6) [back to overview]Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)
NCT00887783 (4) [back to overview]Local Failure Free Survival
NCT00887783 (4) [back to overview]Disease Free Survival
NCT00887783 (4) [back to overview]Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy
NCT00887783 (4) [back to overview]Overall Survival
NCT00906698 (21) [back to overview]Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
NCT00906698 (21) [back to overview]Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
NCT00906698 (21) [back to overview]Number of Patients With Objective Response (OR)
NCT00906698 (21) [back to overview]Progression-free Survival (PFS)
NCT00906698 (21) [back to overview]Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
NCT00906698 (21) [back to overview]Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State
NCT00906698 (21) [back to overview]Best Percentage Change in Tumour Size
NCT00906698 (21) [back to overview]Duration of Disease Control
NCT00906698 (21) [back to overview]Duration of Objective Response
NCT00906698 (21) [back to overview]Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
NCT00906698 (21) [back to overview]Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State
NCT00906698 (21) [back to overview]Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
NCT00906698 (21) [back to overview]Number of Patients With Best Overall Response
NCT00906698 (21) [back to overview]Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State
NCT00906698 (21) [back to overview]Number of Participants With Dose-limiting Toxicities (DLT)
NCT00906698 (21) [back to overview]Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State
NCT00906698 (21) [back to overview]Number of Patients With Disease Control (DC)
NCT00906698 (21) [back to overview]Time to Objective Response
NCT00906698 (21) [back to overview]Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State
NCT00906698 (21) [back to overview]Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State
NCT00906698 (21) [back to overview]Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State
NCT00958724 (7) [back to overview]Progression Free Survival
NCT00958724 (7) [back to overview]Terminal-phase Elimination Half-life
NCT00958724 (7) [back to overview]Objective Response Rate (ORR)
NCT00958724 (7) [back to overview]Best Overall Response
NCT00958724 (7) [back to overview]Duration of Objective Response
NCT00958724 (7) [back to overview]Dose Limiting Toxicity (DLT)
NCT00958724 (7) [back to overview]Area Under the Curve (AUC) Tau
NCT01007942 (9) [back to overview]Clinical Benefit Rate (CBR)
NCT01007942 (9) [back to overview]Vinorelbine Blood Concentrations by Leading Dose and Time Point
NCT01007942 (9) [back to overview]Trastuzumab Blood Concentrations by Leading Dose and Time Point
NCT01007942 (9) [back to overview]PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)
NCT01007942 (9) [back to overview]Progressive-free Survival (PFS) Per Investigator Assessment
NCT01007942 (9) [back to overview]Overall Response Rate (ORR)
NCT01007942 (9) [back to overview]Overall Survival (OS)
NCT01007942 (9) [back to overview]Everolimus Blood Concentrations by Leading Dose and Time Point
NCT01007942 (9) [back to overview]Median Time to Deterioration of the ECOG Performance Status Score
NCT01013740 (7) [back to overview]Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase
NCT01013740 (7) [back to overview]Overall Survival (OS)
NCT01013740 (7) [back to overview]Progression Free Survival (PFS) in the Randomized Phase
NCT01013740 (7) [back to overview]Duration of Response (DOR) in the Randomized Phase
NCT01013740 (7) [back to overview]Time to Response in the Randomized Phase
NCT01013740 (7) [back to overview]Number of Participants With Clinical Benefit (CB) in the Randomized Phase
NCT01013740 (7) [back to overview]Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)
NCT01026220 (7) [back to overview]Relapse-free Survival
NCT01026220 (7) [back to overview]Safety Analysis and Monitoring of Toxic Death
NCT01026220 (7) [back to overview]Second-event-free Survival
NCT01026220 (7) [back to overview]Event Free Survival
NCT01026220 (7) [back to overview]Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative
NCT01026220 (7) [back to overview]Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy
NCT01026220 (7) [back to overview]Overall Survival
NCT01109524 (7) [back to overview]Number of Participants With Drug-Related Treatment-emergent AEs, Drug-Related SAEs, and Drug-Related AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
NCT01109524 (7) [back to overview]Number of Participants With Grades 3 and 4 Drug-Related Treatment-emergent AEs of Special Interest - Treated Population
NCT01109524 (7) [back to overview]Number of Participants With Hematology Laboratory Abnormalities - Treated Population
NCT01109524 (7) [back to overview]Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population
NCT01109524 (7) [back to overview]Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population
NCT01109524 (7) [back to overview]Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population
NCT01109524 (7) [back to overview]Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population
NCT01125566 (4) [back to overview]Objective Response (OR)
NCT01125566 (4) [back to overview]Overall Survival (OS)
NCT01125566 (4) [back to overview]Progression-free Survival (PFS)
NCT01125566 (4) [back to overview]Best RECIST Assessment
NCT01128543 (3) [back to overview]Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24
NCT01128543 (3) [back to overview]Duration of Response
NCT01128543 (3) [back to overview]Progression-free Survival
NCT01185509 (4) [back to overview]Objective Response Rate (ORR)
NCT01185509 (4) [back to overview]Clinical Benefit Rate (CBR)
NCT01185509 (4) [back to overview]Progression-Free Survival (PFS)
NCT01185509 (4) [back to overview]Baseline Level of Circulating Tumor Cells (CTCs)
NCT01196078 (12) [back to overview]Time to Disease Progression
NCT01196078 (12) [back to overview]Percentage of Participants With Disease Progression
NCT01196078 (12) [back to overview]Changes in Quality of Life as Measured by the FACT Questionnaire
NCT01196078 (12) [back to overview]Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change
NCT01196078 (12) [back to overview]Percentage of Participants Achieving Disease Control
NCT01196078 (12) [back to overview]Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)
NCT01196078 (12) [back to overview]Overall Survival: Time to Event
NCT01196078 (12) [back to overview]Overall Survival: Percentage of Participants With an Progressive Disease or Death
NCT01196078 (12) [back to overview]Duration of Response Among Participants Who Achieved Either a CR or PR
NCT01196078 (12) [back to overview]Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change
NCT01196078 (12) [back to overview]Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire
NCT01196078 (12) [back to overview]Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire
NCT01214616 (7) [back to overview]Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course
NCT01214616 (7) [back to overview]AUC0-∞ for Vinorelbine
NCT01214616 (7) [back to overview]AUCÏ„,ss for Afatinib
NCT01214616 (7) [back to overview]Cmax for Vinorelbine
NCT01214616 (7) [back to overview]Cmax,ss for Afatinib
NCT01214616 (7) [back to overview]Drug-related Adverse Events
NCT01214616 (7) [back to overview]Objective Tumour Response
NCT01222715 (3) [back to overview]Event Free Survival Probability
NCT01222715 (3) [back to overview]Rate of Dose-Limiting Toxicities
NCT01222715 (3) [back to overview]Response Rate (CR + PR)
NCT01271725 (9) [back to overview]Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1
NCT01271725 (9) [back to overview]Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher
NCT01271725 (9) [back to overview]Progression Free Survival (PFS)
NCT01271725 (9) [back to overview]Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)
NCT01271725 (9) [back to overview]Best Overall Response According to RECIST v1.1 (With Confirmation)
NCT01271725 (9) [back to overview]Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values
NCT01271725 (9) [back to overview]Duration of Objective Response According to RECIST v1.1
NCT01271725 (9) [back to overview]Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)
NCT01271725 (9) [back to overview]Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)
NCT01305941 (9) [back to overview]Intracranial Objective Response Rate- Modified RECIST Criteria
NCT01305941 (9) [back to overview]Extracranial Response
NCT01305941 (9) [back to overview]Overall Survival
NCT01305941 (9) [back to overview]Extracranial Time to Progression
NCT01305941 (9) [back to overview]Functional Assessment Cancer Therapy- Breast (FACT-B) From Baseline to 9 Weeks of Treatment to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life
NCT01305941 (9) [back to overview]Intracranial Response Rate- MacDonald Criteria
NCT01305941 (9) [back to overview]Functional Assessment of Cancer Therapy- Brain (FACT-Br) Change From Baseline to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life
NCT01305941 (9) [back to overview]Toxicity
NCT01305941 (9) [back to overview]Time to Intracranial Progression.
NCT01325428 (11) [back to overview]Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
NCT01325428 (11) [back to overview]Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).
NCT01325428 (11) [back to overview]Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
NCT01325428 (11) [back to overview]Part A: Progression Free Survival.
NCT01325428 (11) [back to overview]Part A: Duration of Unconfirmed Objective Response.
NCT01325428 (11) [back to overview]Progression Free Survival Over the Whole Sudy.
NCT01325428 (11) [back to overview]Part B: Duration of Unconfirmed Objective Response.
NCT01325428 (11) [back to overview]Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
NCT01325428 (11) [back to overview]Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
NCT01325428 (11) [back to overview]Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).
NCT01325428 (11) [back to overview]Part B: Progression Free Survival.
NCT01441596 (3) [back to overview]Patient Benefit Rate at 12 Weeks
NCT01441596 (3) [back to overview]Overall Survival
NCT01441596 (3) [back to overview]Progression-Free Survival
NCT01443078 (2) [back to overview]Pathologic Response Rate
NCT01443078 (2) [back to overview]PERCIST Partial Metabolic Response
NCT01454934 (3) [back to overview]Objective Response Rate (ORR)
NCT01454934 (3) [back to overview]Overall Survival (OS)
NCT01454934 (3) [back to overview]Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)
NCT01497860 (1) [back to overview]Progression-free Survival
NCT01565083 (11) [back to overview]Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
NCT01565083 (11) [back to overview]Percentage of Participants Who Died From Any Cause
NCT01565083 (11) [back to overview]Overall Survival (OS)
NCT01565083 (11) [back to overview]Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1
NCT01565083 (11) [back to overview]Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
NCT01565083 (11) [back to overview]Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1
NCT01565083 (11) [back to overview]Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause
NCT01565083 (11) [back to overview]Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1
NCT01565083 (11) [back to overview]Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1
NCT01565083 (11) [back to overview]Time to Response as Assessed by Investigator According to RECIST v 1.1
NCT01565083 (11) [back to overview]Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score
NCT02117024 (6) [back to overview]Survival at 12 Months
NCT02117024 (6) [back to overview]Time to Progression (TTP)
NCT02117024 (6) [back to overview]Survival at 6 Months
NCT02117024 (6) [back to overview]Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)
NCT02117024 (6) [back to overview]Progression-Free Survival (PFS)
NCT02117024 (6) [back to overview]Overall Survival (OS)
NCT02352948 (10) [back to overview]Percentage of Participants Alive at 12 Months (OS12)
NCT02352948 (10) [back to overview]PFS, Contribution of the Components Analysis of Sub-study B
NCT02352948 (10) [back to overview]Time From Randomisation to Second Progression (PFS2) of Sub-study B
NCT02352948 (10) [back to overview]Percentage of Participants Alive and Progression Free at 6 Months (APF6)
NCT02352948 (10) [back to overview]Progression-Free Survival (PFS)
NCT02352948 (10) [back to overview]Duration of Response (DoR)
NCT02352948 (10) [back to overview]Objective Response Rate (ORR)
NCT02352948 (10) [back to overview]OS, Contribution of the Components Analysis of Sub-study B
NCT02352948 (10) [back to overview]Overall Survival (OS)
NCT02352948 (10) [back to overview]Percentage of Participants Alive and Progression Free at 12 Months (APF12)
NCT02555657 (17) [back to overview]Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10
NCT02555657 (17) [back to overview]Overall Survival in Participants With PD-L1 CPS ≥1
NCT02555657 (17) [back to overview]Overall Survival in All Participants
NCT02555657 (17) [back to overview]Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10
NCT02555657 (17) [back to overview]Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response
NCT02555657 (17) [back to overview]Overall Response Rate Per RECIST 1.1 in All Participants
NCT02555657 (17) [back to overview]Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response
NCT02555657 (17) [back to overview]Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response
NCT02555657 (17) [back to overview]Number of Participants Who Discontinued Study Treatment Due to an Adverse Event
NCT02555657 (17) [back to overview]Number of Participants Who Experienced One or More Adverse Events
NCT02555657 (17) [back to overview]Disease Control Rate Per RECIST 1.1 in All Participants
NCT02555657 (17) [back to overview]Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
NCT02555657 (17) [back to overview]Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
NCT02555657 (17) [back to overview]Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10
NCT02555657 (17) [back to overview]Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
NCT02555657 (17) [back to overview]Progression-Free Survival Per RECIST 1.1 in All Participants
NCT02555657 (17) [back to overview]Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1
NCT02574455 (14) [back to overview]Overall Survival (OS) in ITT Population
NCT02574455 (14) [back to overview]Overall Survival (OS) in BM-ve Population
NCT02574455 (14) [back to overview]Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug
NCT02574455 (14) [back to overview]Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score
NCT02574455 (14) [back to overview]Time to Progression (TTP) by IRC Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population
NCT02574455 (14) [back to overview]Time to Progression (TTP) by Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Time to Objective Response by the Investigator Assessment in BM-ve Population
NCT02574455 (14) [back to overview]Progression-Free Survival (PFS) by IRC Assessment in the ITT Population
NCT02574455 (14) [back to overview]Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline
NCT02574455 (14) [back to overview]Time to Objective Response by the IRC Assessment in BM-ve Population
NCT02610140 (13) [back to overview]Percentage of Participants With Confirmed Improvement of Pain
NCT02610140 (13) [back to overview]Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)
NCT02610140 (13) [back to overview]Objective Response Rate (ORR)
NCT02610140 (13) [back to overview]Number of Deaths
NCT02610140 (13) [back to overview]Duration of Response (DOR)
NCT02610140 (13) [back to overview]Durable Response Rate (DRR)
NCT02610140 (13) [back to overview]Disease Control Rate (DCR)
NCT02610140 (13) [back to overview]Overall Survival (OS), [95% CI]
NCT02610140 (13) [back to overview]Overall Survival (OS) - Addendum
NCT02610140 (13) [back to overview]Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma
NCT02610140 (13) [back to overview]Progression-free Survival (PFS), [95% CI]
NCT02610140 (13) [back to overview]Time to Worsening of Pain
NCT02610140 (13) [back to overview]Time to Worsening of Symptoms Characteristic of Mesothelioma
NCT02658084 (1) [back to overview]Phase 1 - Rate of Participants Experiencing Adverse Events
NCT02915744 (11) [back to overview]Progression-Free Survival in Brain Metastasis (PFS-BM)
NCT02915744 (11) [back to overview]Clinical Benefit Rate (CBR)
NCT02915744 (11) [back to overview]Compare Health-Related Quality of Life (HRQoL) Using the Brief Fatigue Inventory (BFI)
NCT02915744 (11) [back to overview]Compare Health-Related Quality of Life (HRQoL) Using the European Organisation for Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) Module With the Brain Neoplasms 20-question (BN-20) Subscale.
NCT02915744 (11) [back to overview]Duration of Response (DoR)
NCT02915744 (11) [back to overview]Compare Health-Related Quality of Life (HRQoL) Using the the EuroQoL 5D (EQ-5D-5Lâ„¢)
NCT02915744 (11) [back to overview]Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival
NCT02915744 (11) [back to overview]Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3
NCT02915744 (11) [back to overview]Overall Survival (OS) of Patients
NCT02915744 (11) [back to overview]Progression-Free Survival (Outside the Central Nervous System)
NCT02915744 (11) [back to overview]Progression-Free Survival (Overall)
NCT02991482 (6) [back to overview]Time to Treatment Failure.
NCT02991482 (6) [back to overview]Objective Response Rate by Independent Radiological Review
NCT02991482 (6) [back to overview]Progression Free Survival (PFS) Assessed by Investigator
NCT02991482 (6) [back to overview]Progression Free Survival (PFS) as Assessed by Independent Radiological Review
NCT02991482 (6) [back to overview]Overall Survival.
NCT02991482 (6) [back to overview]Percentage of Patients Experienced AEs/SAEs
NCT02998528 (4) [back to overview]Time to Death or Distant Metastases (TTDM)
NCT02998528 (4) [back to overview]Major Pathologic Response (MPR) Rate
NCT02998528 (4) [back to overview]Event-Free Survival (EFS)
NCT02998528 (4) [back to overview]Pathologic Complete Response (pCR) Rate
NCT03191786 (14) [back to overview]Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1
NCT03191786 (14) [back to overview]Overall Survival (OS)
NCT03191786 (14) [back to overview]Overall Survival in Participants With PD-L1 Positive Status
NCT03191786 (14) [back to overview]Percentage of Participants With At Lease One Adverse Event
NCT03191786 (14) [back to overview]Percentage of Participants With Objective Response Rate, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)
NCT03191786 (14) [back to overview]Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1
NCT03191786 (14) [back to overview]Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1 in Participants With PD-L1 Positive Status
NCT03191786 (14) [back to overview]Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
NCT03191786 (14) [back to overview]Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score
NCT03191786 (14) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
NCT03191786 (14) [back to overview]Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score
NCT03191786 (14) [back to overview]OS Rates at the 6, 12, 18, 24-Months Timepoints
NCT03191786 (14) [back to overview]Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score
NCT03191786 (14) [back to overview]Time to Deterioration in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score
NCT03262935 (6) [back to overview]Overall Survival
NCT03262935 (6) [back to overview]Objective Response Rate
NCT03262935 (6) [back to overview]Investigator Assessed Progression Free Survival
NCT03262935 (6) [back to overview]Patient Reported Outcomes for Health Related Quality of Life
NCT03262935 (6) [back to overview]Patient Reported Outcomes for Health Related Quality of Life
NCT03262935 (6) [back to overview]Progression Free Survival
NCT03386721 (5) [back to overview]Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
NCT03386721 (5) [back to overview]Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1
NCT03386721 (5) [back to overview]Percentage of Participants With Adverse Events (AEs)
NCT03386721 (5) [back to overview]Overall Survival (OS)
NCT03386721 (5) [back to overview]Progression-Free Survival (PFS) According to RECIST Version 1.1

Radiographic Response Assessed by Macdonald Criteria Every 2 Months

All patients will have their tumor measurements recorded at baseline and at the time of each MRI scan. Lesions must be measured in two dimensions. (NCT00026494)
Timeframe: 2 years

,,,
Interventionparticipants (Number)
Stable Disease (SD)Progression of Disease (POD)Partial Response (PR)Minor Response (MR)Complete Response (CR)
15mg/m2 - Vinorelbine32000
20mg/m2 - Vinorelbine21100
25mg/m2 - Vinorelbine411010
30mg/m2 - Vinorelbine312001

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Progression-free Survival

(NCT00041067)
Timeframe: 2 years

Interventionmonths (Median)
Trastuzumab, Docetaxel, Vinorelbine and Filgrastim20

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Toxicity

Number of patients for whom highest grade of toxicity observed during treatment. Only adverse events that are possibly, probably or definitely related to study drug are reported. (NCT00041067)
Timeframe: toxicities assessed every 3 weeks during treatment, for up to 3 years if no progession

InterventionParticipants (Number)
Alkaline phosphatase increaseAnemiaArthralgiaBone painCatheter related infectionChest pain,not cardio or pleurDehydrationDepressionDiarrhea without colostomyDyspepsia/heartburnDyspneaFatigue/malaise/lethargyFebrile neutropeniaHeadacheHyperglycemiaHypermagnesemiaHypokalemiaHypophosphatemiaHypotensionHypoxiaInfection w/o 3-4 neutropeniaInfection with 3-4 neutropeniaLVEF decrease/CHFLeukopeniaLymphopeniaMuscle weakness (not neuro)NauseaNeutropenia/granulocytopeniaPRBC transfusionPain-otherPericar. effusion/pericarditisPneumonitis/infiltratesRespiratory infect w/ neutropRespiratory infection, unk ANCSGPT (ALT) increaseSensory neuropathySyncopeTearingThrombosis/embolismTransplant-pRBC transfusionVomiting
Docetaxel + Vinorelbine + G-CSF + Trastuzumab1712221121294361211141111213161313111511112

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Response Rate (Complete and Partial, Confirmed and Unconfirmed)

Response was measured by the RECIST criteria. A patient was considered a responder if there was confirmed or unconfirmed partial or complete response. All others were considered non-responders even if the patient was technically not assessable due to different measurement techniques at the two time points. (NCT00041067)
Timeframe: response assessed after every 3 cycles (9 weeks) during treatment for up to 3 years if no progession

Interventionparticipants (Number)
Trastuzumab, Docetaxel, Vinorelbine and Filgrastim53

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Survival at 1 Year

(NCT00041067)
Timeframe: 1 year

Interventionpercentage of patients (Number)
Trastuzumab, Docetaxel, Vinorelbine and Filgrastim93

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To Measure the Qualitative and Quantitative Toxicity of This Regimen.

(NCT00041470)
Timeframe: <=18 months

InterventionParticipants (Count of Participants)
>=Grade 3 Toxicityserious adverse events
Weekly Paclitaxel, Vinorelbine and GCSF3010

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Duration of Overall Survival (OS)

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. (NCT00064077)
Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Interventionmonths (Median)
Arm I (Paclitaxel, Cisplatin)12.87
Arm II (Vinorelbine, Cisplatin)9.99
Arm III (Gemcitabine, Cisplatin)10.28
Arm IV (Topotecan, Cisplatin)10.25

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Duration of Progression-free Survival (PFS)

Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions. (NCT00064077)
Timeframe: Baseline, every other cycle during treatment, then every 3 months for 2 years, the every 6 months for 3 years (up to 5 years)

Interventionmonths (Median)
Arm I (Paclitaxel, Cisplatin)5.82
Arm II (Vinorelbine, Cisplatin)3.98
Arm III (Gemcitabine, Cisplatin)4.70
Arm IV (Topotecan, Cisplatin)4.57

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Pain, Assessed by Brief Pain Inventory

"Single item from the Brief Pain Inventory (BPI) assessing worst pain in the past 24 hours, on a 0-10 scale with a higher score indicating more pain than a low score." (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)4.03.53.62.3
Arm II (Vinorelbine, Cisplatin)3.93.54.03.2
Arm III (Gemcitabine, Cisplatin)3.33.43.53.7
Arm IV (Topotecan, Cisplatin)3.63.62.52.9

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Patient Reported Neurotoxicity Symptoms as Measured With the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale (Short Version) (FACT/GOG-Ntx Subscale).

The FACT/GOG-Ntx subscale contains 4 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Ntx score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The Ntx score ranges 0-16 with a large score suggests less neurotoxicity. (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)14.414.113.111.1
Arm II (Vinorelbine, Cisplatin)13.513.313.111.4
Arm III (Gemcitabine, Cisplatin)14.213.714.112.3
Arm IV (Topotecan, Cisplatin)14.114.214.413.1

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Patient-reported Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT)-Cervical Trial Outcome of Index (FACT-Cx TOI)

The FACT-Cx TOI is a scale for assessing general QOL of cervical cancer patients.consisting of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Cervical Cancer subscale (15 items). Each item in the FACT-Cx TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative statements (or questions), reversal was performed prior to score calculation. According to the FACIT measurement system, a subscale score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The score is calculated as the sum of the subscale scores if more than 80% of the FACT-Cx TOI items provide valid answers and all of the component subscales have valid scores. The score ranges 0-116 with a large score suggesting better QOL. (NCT00064077)
Timeframe: Baseline (pre-cycle 1), Pre-cycle 2, Pre-cycle 5, 9 months post cycle 1

,,,
Interventionunits on a scale (Mean)
BaselinePre-cycle 2Pre-cycle 59 months post cycle 1
Arm I (Paclitaxel, Cisplatin)66.665.270.571.9
Arm II (Vinorelbine, Cisplatin)69.165.566.669.9
Arm III (Gemcitabine, Cisplatin)67.965.364.568.6
Arm IV (Topotecan, Cisplatin)68.166.268.470.9

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Overall Survival

The time between the date of randomization and the date of death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

InterventionMonths (Median)
Experimental Group10.2
Comparator Group7.6

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Progression-Free Survival (PFS)

The time between the date of randomization and the date of the initial documentation of progressive/relapsed disease or death due to any cause. (NCT00088530)
Timeframe: 18 months after 6 cycles of treatment; approximately 24 months

Interventionmonths (Median)
Experimental Group5.3
Comparator Group2.6

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Complete Response (CR) and Complete Response Unconfirmed (CRu)

Proportion of patients with a best response of complete response (CR) or Complete Response unconfirmed (CRu) in the End Of Treatment (EOT) or End Of Study (EOS) analyses by independent assessment in the Intent-to-treat (ITT) population through the End of Treatment (EOT) (NCT00088530)
Timeframe: EOT; approximately 6 months

,
Interventionpercentage of randomized patients (Number)
END OF TREATMENT: CR/CRu, n (%)END OF STUDY: CR/CRu, n (%)
Comparator Group5.77.1
Experimental Group20.024.3

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Overall Response Rate (ORR) Lasting at Least 4 Months

The proportion of patients with Complete response or Partial Response with a difference from the first documented objective response to disease progression or death of at least 4 months. (NCT00088530)
Timeframe: approximately 24 months

Interventionparticipants (Number)
Experimental Group12
Comparator Group6

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Overall Response Rate

"Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response)~Complete Response (CR)- Disappearance of all target lesions~Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter." (NCT00088985)
Timeframe: 6 months following treatment

InterventionParticipants (Count of Participants)
Dendritic Cell Vaccine1

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Overall Survival as Assessed by Time

Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method. (NCT00093808)
Timeframe: Up to 5 years

Interventionmonths (Median)
Capecitabine + Vinorelbine + Trastuzumab28.5

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Duration of Response as Measured by RECIST Criteria

Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. (NCT00093808)
Timeframe: Up to 5 years

Interventionmonths (Median)
Capecitabine + Vinorelbine + Trastuzumab13.2

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Confirmed Response Rate

A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00093808)
Timeframe: Up to 5 years

Interventionproportion of patients (Number)
Capecitabine + Vinorelbine + Trastuzumab0.67

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Time to Progression (TTP)

Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for any evaluations, that patient will be censored for progression of disease at day one post-registration. Otherwise, for patients that do not progress, censoring will occur at the last follow up date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or unequivocal progression of existing non-target lesions. (NCT00093808)
Timeframe: Up to 5 years

Interventionmonths (Median)
Capecitabine + Vinorelbine + Trastuzumab11.3

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Nadir Measurement for Absolute Neutrophil (ANC), White Blood Cell (WBC) and Platelet Count

Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment. (NCT00140140)
Timeframe: up to week 129 (longest treatment)

,,
Intervention10^9/L (Mean)
ANCWBCPlatelets
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine1.742.79221.5
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine1.002.56187.2
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine1.722.92222.7

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Kaplan-Meier Estimates for Participant Survival

Participant survival is the time from the first dose of study drug to participant death from any cause. Participants that did not die were censored at the last known time the participant was alive. (NCT00140140)
Timeframe: up to 39 months

Interventionmonths (Median)
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine32.7
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine29.2
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine22.2

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Participants With Dose Limiting Toxicities

"Toxicities were evaluated based on the U.S. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Any drug-related toxicities CTC Grade 3 or higher were considered dose limiting. Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death. Other conditions considered dose-limiting toxicities include:~requirement of a dose adjustment during the first 4 weeks~a dose delay of >3 weeks during the first 4 weeks Grade 3 or greater toxicities attributed to the use of Herceptin were not considered dose-limiting toxicities.~The optimal tolerated dose of ABI-007 and vinorelbine given concurrently was defined as the dose administered in the absence of DLTs." (NCT00140140)
Timeframe: up to month 1

Interventionparticipants (Number)
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine2
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine2
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine2

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Kaplan Meier Estimate for Progression-Free Survival (PFS)

"PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause) whichever occurred first. Participants that did not have progression or have not died were censored at the last known time the participant was progression free. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Because no patients died as a result of a non-disease progression event, the analysis of PFS was identical to the analysis for TTP." (NCT00140140)
Timeframe: up to month 30

Interventionmonths (Median)
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine8.8
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine7.9
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine4.2

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Kaplan Meier Estimate for Time to Disease Progression (TTP)

"Time to progression was defined as the time from the first dose of study drug to the start of progression. Participants that did not have progression were censored at the last known time the patient was evaluated for progression. Participants that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion." (NCT00140140)
Timeframe: up to month 30

Interventionmonths (Median)
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine8.8
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine7.9
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine4.2

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Nadir Measurement for Hemoglobin (Hgb)

Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest observed measurement is the nadir. Blood counts were performed each week of treatment. (NCT00140140)
Timeframe: up to week 129 (longest treatment)

Interventiong/L (Mean)
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine89.3
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine89.7
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine83.5

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Kaplan-Meier Estimate for Duration of Response

"Duration of response is defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Patients that did not have progression or have not died were censored at the last known time the patient was progression free. Patients that initiate other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.~Complete response (CR) and partial response (PR) are defined in outcome #1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameters of target lesions; or the appearance of one or more new lesions; or the unequivocal progression of a non-target lesion." (NCT00140140)
Timeframe: up to month 30

Interventionmonths (Median)
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine10.4
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine7.9
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine9.6

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Participants With Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)

"Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation.~Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits." (NCT00140140)
Timeframe: up to month 30

Interventionpercentage of participants (Number)
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine25
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine16.7
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine33.3

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Percentage of Participants With Stable Disease for >= 16 Weeks, or Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0)

"Disease control is stable disease (SD) for >=16 weeks + complete response (CR) + partial response (PR). See Outcome #1 for definitions of CR and PR.~RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions." (NCT00140140)
Timeframe: up to month 30

,,
Interventionpercentage of participants (Number)
Disease controlComplete responsePartial responseStable disease >=16 weeks
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine7502550
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine66.701750
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine33.30330

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Percentage of Participants With Discontinued, Delayed or Interrupted Therapy

Percentage of participants who had discontinued therapy or had a delayed dose or an interrupted (omitted) dose due to toxicities/adverse events. (NCT00140140)
Timeframe: up to week 129

,,
Interventionpercentage of participants (Number)
At least 1 ABI-007 dose reductionAt least 1 Vinorelbine dose reductionAt least 1 ABI-007 dose interruptionAt least 1 Vinorelbine dose interruptionAt least 1 therapy delay
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine50500075
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine50500083
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine17170067

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Participant Counts of the Most Severe Grade for Absolute Neutrophil (ANC), White Blood Cell (WBC), Platelet, and Hemoglobin Counts as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Experience (NCI CTCAE v3)

"Myelosuppression is a decrease in the ability of the bone marrow to produce blood cells. The lowest measured (nadir) blood counts were graded using NCI CTCAE version 3.~ANC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 1.5*10^9/L; Grade 2 = <1.5 - 1.0*10^9/L; Grade 3 = <1.0 - 0.5*10^9/L; Grade 4 = <0.5*10^9/L~WBC:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 3.0*10^9/L; Grade 2 = <3.0 - 2.0*10^9/L; Grade 3 = <2.0 - 1.0*10^9/L; Grade 4 = <1.0*10^9/L~Platelets:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 75.0*10^9/L; Grade 2 = <75.0 - 50.0*10^9/L; Grade 3 = <50.0 - 25.0*10^9/L; Grade 4 = <25.0*10^9/L~Hemoglobin:~Grade 0 = within normal limits; Grade 1 = < lower limit of normal - 100 g/L ; Grade 2 = <100 - 80 g/L; Grade 3 = <80 - 65 g/L; Grade 4 = <65 g/L" (NCT00140140)
Timeframe: up to week 129 (longest treatment)

,,
Interventionparticipants (Number)
ANC: grade 0ANC: grade 1ANC: grade 2ANC: grade 3ANC: grade 4WBC: grade 0WBC: grade 1WBC: grade 2WBC: grade 3WBC: grade 4Platelets: grade 0Platelets: grade 1Platelets: grade 2Platelets: grade 3Platelets: grade 4Hemoglobin: grade 0Hemoglobin: grade 1Hemoglobin: grade 2Hemoglobin: grade 3Hemoglobin: grade 4
Part 1: 80 mg ABI-007 + 15 mg Vinorelbine11020201104000002110
Part 2: 80 mg ABI-007 + 15 mg Vinorelbine11103301204110010320
Part 2: 90 mg ABI-007 + 20 mg Vinorelbine30012112206000000420

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Pathological Complete Response After Preoperative Therapy With Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Patients With HER-2 Positive Early Breast Cancer

Pathological Complete Response is defined as the complete disappearance of invasive tumor in the breast at the time of surgery (NCT00148668)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Arm 117
Arm 231

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Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status

Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL. (NCT00148798)
Timeframe: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt cycle 3At month 6
Cetuximab Plus Chemotherapy45.7248.3354.71
Chemotherapy Alone46.3651.5552.92

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Safety - Number of Patients Experiencing Any Adverse Event

Please refer to Adverse Events section for further details (NCT00148798)
Timeframe: time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionparticipants (Number)
Cetuximab Plus Chemotherapy545
Chemotherapy Alone549

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Disease Control Rate

The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria). (NCT00148798)
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionpercentage of participants (Number)
Cetuximab Plus Chemotherapy72.5
Chemotherapy Alone71.5

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Best Overall Response Rate

The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria). (NCT00148798)
Timeframe: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionpercentage of participants (Number)
Cetuximab Plus Chemotherapy36.4
Chemotherapy Alone29.2

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Progression-free Survival Time

"Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.~Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment." (NCT00148798)
Timeframe: Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy4.8
Chemotherapy Alone4.8

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Overall Survival Time (OS)

Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. (NCT00148798)
Timeframe: Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Interventionmonths (Median)
Cetuximab Plus Chemotherapy11.3
Chemotherapy Alone10.1

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A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations

Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011. (NCT00148798)
Timeframe: Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.

Interventionug/mL (Mean)
Cetuximab Concentration at End of Infusion Week 1223.1
Cetuximab Concentration Before Infusion Week 751.5

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Quality of Life Assessment (EORTC QLQ-C30) Social Functioning

Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning. (NCT00148798)
Timeframe: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

,
Interventionscores on a scale (Least Squares Mean)
At baselineAt cycle 3At month 6
Cetuximab Plus Chemotherapy66.1758.0567.36
Chemotherapy Alone64.7367.1366.47

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Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Chemotherapy, Trastuzumab, and G-CSF Against a Her-2 Overexpressing Target in Vitro

"Buffy coat effector cells were isolated by centrifugation from heparinized blood, washed, and counted. SKBR3 target cells were labeled with 51-Cr at 100 uCi per 5 x 105 cells for 1 hour at 37 C, washed and effector cells and target cells were plated at a ratio of 70:1 in 96 well microtiter plates, with trastuzumab 2 ug/ml and with no antibody. After addition of the target cells, the plate was centrifuged gently at 1200 rpm to pellet cells, the plate was incubated for 4 hours at 37C, and 100 uL of supernatant was measured on a gamma counter set for 51Cr counting for 1 minute per tube. Specific lysis in % is defined as follows:~% specific lysis = (counts released into the supernatant under experimental conditions - spontaneous counts released into the supernatant) / (maximum counts released into the supernatant - spontaneous counts released into the supernatant)~Specific lysis at Week 14 was compared to specific lysis at baseline for 17 patients with week 14 samples available." (NCT00169104)
Timeframe: Baseline and 14 weeks

Interventionpercentage of specific lysis (Median)
All Patients1.67

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Antibody Dependent Cell-mediated Cytotoxicity of Effector Cells Isolated From Subjects Receiving Trastuzumab With Either G-CSF or a Saline Placebo Against a Her-2 Overexpressing Target in Vitro

"Buffy coat effector cells were isolated by centrifugation from heparinized blood, and washed and counted. SKBR3 target cells were labeled with 51-Cr at 100 uCi per 5 x 105 cells for 1 hour at 37 C, washed and effector cells and target cells were plated at a ratio of 70:1 in 96 well microtiter plates, with trastuzumab 2 ug/ml and with no antibody. After addition of the target cells, the plate was centrifuged gently at 1200 rpm to pellet cells, the plate was incubated for 4 hours at 37C, and 100 uL of supernatant was measured on a gamma counter set for 51Cr counting for 1 minute per tube. Specific lysis in % is defined as follows:~% specific lysis = (counts released into the supernatant under experimental conditions - spontaneous counts released into the supernatant) / (maximum counts released into the supernatant - spontaneous counts released into the supernatant)~Specific lysis at Day 12 was compared to specific lysis at baseline between the G-CSF group and the placebo group." (NCT00169104)
Timeframe: Baseline and 12 days

Interventionpercentage of specific lysis (Mean)
G-CSF Arm1.47
Placebo Arm1.67

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Safety of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer

"Adverse events were graded per RECIST v4.0. There were two severe adverse events: Grade 3 mental status changes in one subject on the G-CSF arm, and Grade 3 febrile neutropenia in one subject on the Placebo arm.~Refer to Adverse Events Table for specifics." (NCT00169104)
Timeframe: 14 weeks

,
InterventionParticipants (Count of Participants)
Grade 3 mental status changesGrade 3 febrile neutropeniaGrade 4 leukopeniaGrade 4 granulocytopeniaGrade 3 anemiaGrade 3 thrombocytopeniaGrade 3 granulocytopeniaGrade 3 elevation in alkaline phosphataseGrade 3 elevation in ASTGrade 3 elevation in ALTGrade 2 sensory neuropathyGrade 2 arthralgiasGrade 2 constipationGrade 2 tumor painGrade 2 mucositisGrade 2 heartburnGrade 2 anemiaGrade 2 thrombocytopeniaGrade 2 leukopeniaGrade 2 granulocytopeniaGrade 2 elevation in alkaline phosphataseGrade 2 elevation in ASTGrade 2 elevation in ALT
G-CSF Arm10213122101010015031500
Placebo Arm01000011011211104111221

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Clinical Response Rate of the Combination of Trastuzumab, G-CSF, and Vinorelbine in Subjects With Her-2 Overexpressing Metastatic Breast Cancer

"19 subjects (11 on the G-CSF arm and 8 on the placebo arm) completed 14 weeks of treatment and completed restaging at that time.~Responses were evaluated by RECIST criteria." (NCT00169104)
Timeframe: 14 weeks

,
InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseDisease Progression
G-CSF Arm0128
Placebo Arm0431

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Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation

(NCT00194779)
Timeframe: From the initiation of study treatments to 30 days after the end of neoadjuvant treatment or adjuvant treatment if received

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)32

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Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy

Count of patients that relapsed. (NCT00194779)
Timeframe: Up to 8 years

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)7

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Time to Progression

Median time to progression free survival. (NCT00194779)
Timeframe: Up to 5 years

Interventionmonths (Median)
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)NA

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Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)

"Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer >= 1 cm.~Count of participants with either a pCR or mCR." (NCT00194779)
Timeframe: Up to 16 weeks

InterventionParticipants (Count of Participants)
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)29

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OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN

Kaplan-Meier estimate of overall survival, assessed at 1, 2, and 5 years. (NCT00194779)
Timeframe: 1, 2, and 5 years

Interventionsurvival probability (Number)
1 year2 years5 years
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)1.94.90

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Disease-free Survival

Kaplan-Meier estimate of disease-free survival, assessed at 1, 2, and 5 years. (NCT00194779)
Timeframe: 1, 2, and 5 years

Interventiondisease-free survival probability (Number)
1 year2 years5 years
Treatment (Neoadjuvant Therapy, Adjuvant Therapy).97.90.84

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Overall Survival

From the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive. Kaplan-Meier estimate assessed at 5 years. (NCT00194792)
Timeframe: Up to 5 years

Interventionsurvival probability (Number)
Treatment (Hormone Therapy and Chemotherapy)0.88

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Number of Participants With Dose Reduction, Treatment Interruption, or Treatment Discontinuation

Count of patients with dose reduction, treatment interruption, or treatment discontinuation. (NCT00194792)
Timeframe: During adjuvant and neoadjuvant chemotherapy

InterventionParticipants (Count of Participants)
Adjuvant therapyNeoadjuvant therapy
Treatment (Hormone Therapy and Chemotherapy)111

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Quantification of All Grade 2, 3, 4 Adverse Events or Fatal Toxicities

Count of all incidences of grade 2, 3, 4 adverse events and fatal toxicities (NCT00194792)
Timeframe: Monthly during neoadjuvant treatment and then 6 months following treatment (including surgery)

Interventionevents (Number)
Grade 2Grade 3Grade 4Fatal toxicity
Treatment (Hormone Therapy and Chemotherapy)801200

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Number of Participants With Microscopic Pathologic Complete Response and Macroscopic Pathologic Complete Response

Defined as no evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection and the examining pathologist cannot identify gross residual tumor mass in the surgical specimen. (NCT00194792)
Timeframe: From date of treatment start to surgery

InterventionParticipants (Count of Participants)
Treatment (Hormone Therapy and Chemotherapy)0

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Number of Participants With Clinical Response

Defined as a > 50% decrease in sum of the products of the perpendicular diameters of bidimensionally measurable disease. (NCT00194792)
Timeframe: 1 month

InterventionParticipants (Count of Participants)
Treatment (Hormone Therapy and Chemotherapy)19

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Disease-free Survival

Kaplan-Meier estimate assessed at 5 years (NCT00194792)
Timeframe: Up to 5 years

Interventiondisease free survival probability (Number)
Treatment (Hormone Therapy and Chemotherapy)0.76

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Best Disease Response After a Maximum of Six Cycles.

Determine the number of participants for each category of response rates (RR) in newly diagnosed patients with advanced non-small cell lung cancer (NSCLC) who are treated with a chemotherapeutic regimen assigned to them on the basis of expression of the genes ribonucleotide reductase subunit 1 (ERCC1) and excision repair cross-complementing group 1 gene (RRM1) expression. Prior to treatment we measured the level of ERCC1 and RRM1 expression in the patients tumor, on the basis of which the patient would be assigned a specific doublet chemotherapy. (NCT00215930)
Timeframe: 24 Months

InterventionParticipants (Number)
Complete Response (CR)Partial Response (PR)Stable Disease (SD)Progressive Disease (PD)Not Assessible
Double Agent Chemotherapy0232361

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Progression Free Survival (PFS)

PFS was recorded as the time elapsed from the date of first treatment to the date of first evidence for disease progression or death. OS and PFS probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes. (NCT00215930)
Timeframe: 24 Months

InterventionMonths (Median)
Double Agent Chemotherapy6.6

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Overall Survival (OS)

Median Overall Survival of Participants. OS and Progression Free Survival (PFS) probabilities were estimated using the Kaplan-Meier method. For statistical purposes, it is important to note that this trial was not designed to compare outcomes among patients assigned to the different chemotherapies, but rather that molecular analysis directed individualized chemotherapy assignment is feasible and yields promising results in outcomes. (NCT00215930)
Timeframe: 24 Months

InterventionMonths (Median)
Double Agent Chemotherapy13.3

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Progression-free Survival (PFS) in Patients With AJCC Stage IV Metastatic Melanoma Treated With Docetaxel and Vinorelbine as First-line or Post-first Line (Salvage) Systemic Therapy

The primary endpoint is to evaluate the six-month progression-free survival (PFS) in patients with AJCC stage IV metastatic melanoma treated with docetaxel and vinorelbine as first-line or post-first line (salvage) systemic therapy. Progressive disease is defined as any new lesion or a greater than or equal to 20% increase in the largest perpendicular diameter of the sum of the T-lesions identified on contrast enhanced CT or MRI scan. (NCT00256282)
Timeframe: Six months from initial treatment

Interventiondays (Median)
Docetaxel and Vinorelbine Plus Sargramostim134

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Percentage of Patients Alive at One Year

(NCT00256282)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
Docetaxel and Vinorelbine Plus Sargramostim25

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Number of Participants With Response

Response: Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00266110)
Timeframe: 5-6 years

InterventionParticipants (Count of Participants)
Dendritic Cell Vaccine0

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Generation of Interferon Gamma Positive CD8+T Cells

Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for interferon gamma positive CD8+ T cells (NCT00266110)
Timeframe: 13 weeks

Interventionpercentage of cells (Mean)
Dendritic Cell Vaccine15.99

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Generation of E75/E90 Tetramer-positive CD8+ T Cells

Evaluate the ability of peptide-pulsed dendritic cells plus trastuzumab to induce functional antigen specific T cells. Measured by percentage of intracellular cytokine staining for E75/E90 tetramer-positive CD8+ T cells (NCT00266110)
Timeframe: 13 weeks

InterventionPercentage (Mean)
Dendritic Cell Vaccine3.63

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Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).

Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT). (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.49

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Intensive Therapy Free Survival (ITFS).

Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy. (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.89

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Overall Survival

Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact. (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.99

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Event Free Survival (EFS)

Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS). (NCT00302003)
Timeframe: At 60 months

InterventionProbability of survival (Number)
Group 10.79

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Overall Survival

Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint. (NCT00324805)
Timeframe: From registration to death, up to 10 years

Interventionmonths (Median)
Arm I (Chemotherapy)NA
Arm II (Chemotherapy, Bevacizumab)85.8

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Disease-free Survival

Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment. (NCT00324805)
Timeframe: From registration to death, up to 10 years

Interventionmonths (Median)
Arm I (Chemotherapy)42.9
Arm II (Chemotherapy, Bevacizumab)40.6

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Time to Response

Time to response (Complete Response(CR) or Partial Response (PR) is defined as the time from the date of study enrollment to the first date when the measurement criteria are met for complete response or partial response (whichever status is recorded first). CR=Disappearance of target lesions lesions. PR=≥30% size decrease of lesions. (NCT00325234)
Timeframe: Baseline to response (up to 7.8 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin1.8
Gemcitabine/Vinorelbine1.8

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Duration of Response (DOR)

DOR-RECIST criteria of (Complete Response [CR =Disappearance of lesions] or Partial Response [PR=≥30% size decrease of lesions]) is defined as time from the date when measurement criteria are met for CR or PR until the date of first observation of progressive disease (PD) or death from study disease. For participants who die from causes other than study disease and without PD, DOR will be censored at the date of death. For participants who have not died as of the data cut-off date who are without PD, DOR was censored at last contact date. (NCT00325234)
Timeframe: Time of response to progressive disease (up to 19 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin7.7
Gemcitabine/Vinorelbine7.5

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Time to Progressive Disease (PD)

Time to PD is defined as the time from the date of study enrollment to the first documented date of PD or death from study disease. For participants who die from causes other than study disease and without PD, time to PD was censored at the date of death. For participants not known to have died as of the data cut-off date and do not have PD, time to PD was censored at the last contact date. For participants who received subsequent chemotherapy (after discontinuation from the study chemotherapy) prior to disease progression, time to PD was censored at the date of subsequent chemotherapy. (NCT00325234)
Timeframe: Baseline to measured PD (up to 25.1 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin5.1
Gemcitabine/Vinorelbine5.6

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Time To Treatment Failure (TTTF)

TTTF is defined as the time from date of study enrollment to the first documented date of death, PD, or study treatment discontinuation due to adverse event (AE). For participants not known to have discontinued as of the data cut-off date, TTTF is censored at the last contact date. For participants who discontinued for reasons other than death, PD, or AE, TTTF is censored at the date of discontinuation. (NCT00325234)
Timeframe: Baseline to end of treatment (up to 21.9 months)

InterventionMonths (Median)
Pemetrexed/Carboplatin4.8
Gemcitabine/Vinorelbine5.1

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Number of Participants With Adverse Events (AE)

A listing of adverse events is presented in the Reported Adverse Event Module. (NCT00325234)
Timeframe: every cycle up to twenty-one 21-day cycles (plus 30 days of follow-up)

,
Interventionparticipants (Number)
Adverse EventsSerious Adverse Events
Gemcitabine/Vinorelbine6622
Pemetrexed/Carboplatin6418

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Tumor Response Rate

Participants with best overall response determined from complete response (CR) or partial response (PR) according to Response Criteria in Solid Tumors (RECIST) criteria. For CR or PR, best response must be confirmed. A second assessment performed at 28 days. Two determinations of CR before progression required for rate to=CR. Evaluations include: CR=Disappearance of lesions. PR=≥30% size decrease of lesions. Progressive Disease (PD)=≥20% size increase of lesions. Stable Disease (SD)=Not enough shrinkage for PR nor enough increase for PD. Overall Response Rate=PR+CR/Qualified Participants*100. (NCT00325234)
Timeframe: Baseline up to 30 days of follow-up after 21 cycles of treatment

,
Interventionpercentage of participants (Number)
Overall ResponseComplete ResponsePartial ResponseStable DiseaseProgressive DiseaseUnknown
Gemcitabine/Vinorelbine29.53.326.234.427.98.2
Pemetrexed/Carboplatin26.60.026.635.926.610.9

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Event Free Survival (EFS)

Event free survival is the time from trial entry until progression, death, or termination of treatment due to nonresponse. Patients who went on to receive a stem cell transplant (SCT) were not censored from the EFS survival at the time of transplant and were only considered failures at the time of relapse or death from any cause. The median EFS with 95% confidence interval (CI) was estimated using the Kaplan Meier method. (NCT00337194)
Timeframe: Up to 10 years

Interventionmonths (Median)
Arm I (SGN-30, Chemotherapy)11.3
Arm II (Placebo, Chemotherapy)4.1

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Number of Participants With Overall Response (OR)

The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): >= 50% reduction in sum of the product of diameters of indicator lesions. (NCT00337194)
Timeframe: Up to 10 years

Interventionparticipants (Number)
Arm I (SGN-30, Chemotherapy)15
Arm II (Placebo, Chemotherapy)4

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Overall Survival (OS) At 1 Year

Percentage of patients who were alive at 1 year. The 1-year survival rate was estimated using the Kaplan Meier method. (NCT00337194)
Timeframe: 1 year

Interventionpercentage of participants (Median)
Arm I (SGN-30, Chemotherapy)86
Arm II (Placebo, Chemotherapy)30

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Peak Serum Level of Monoclonal Antibody SGN-30

Record the highest serum level of monoclonal antibody SGN-30 achieved. (NCT00337194)
Timeframe: Up to day 21 of course 6

Interventionmg/ml (Median)
Arm I (SGN-30, Chemotherapy)339

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sCD30 Levels

A 2-sided t-test with alpha = 0.05 will be used to compare sCD30 levels between responders (OR) and non-responders groups. (NCT00337194)
Timeframe: Up to day 21 of course 6

InterventionU/ml (Median)
Responders174.2
Non-responders76.5

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Fc Gamma Receptor Polymorphisms

Fisher's exact test with 2-sided alpha = 0.05 will be used to compare the response probabilities in patients with V/V (valine expression), V/F (heterozygous), and F/F (homozygous for phenylalanine) for each of Fc gamma RIIIa a (NCT00337194)
Timeframe: Baseline

,
Interventionparticipants (Number)
V/VF/FF/V
Non-responders065
Responders0107

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Number of Participants With Grade 3 or 4 Toxicity

Grade 3 and 4 non-hematologic toxicity during protocol therapy. The number of patients that experience CTC Version 4 grade 3 or higher non-hematologic at any time during protocol therapy (NCT00381940)
Timeframe: 4 weeks following completion of therapy

InterventionParticipants (Count of Participants)
Treatment (Ifosfamide, Vinorelbine, Bortezomib)9

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Rate of Successful PBSC Harvest

Success is defined as the ability to harvest 2x10^6 CD34+ cells/kg within 5 collection days. (NCT00381940)
Timeframe: After 2 cycles

InterventionParticipants (Count of Participants)
Treatment (Ifosfamide, Vinorelbine, Bortezomib)19

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Complete Response (CR)

CR is defined as at least 80% reduction in the sum of the products of the perpendicular diameters of each of the nodal masses or return to normal size, along with negative nuclear medicine imaging. (NCT00381940)
Timeframe: After 2 cycles of treatment

Interventionparticipants (Number)
With CRWithout CR
Treatment (Ifosfamide, Vinorelbine, Bortezomib)221

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Induction Success Rate

Induction success is defined as achieving CR or PR without a targeted primary toxicity. Primary toxicity includes toxic death (which is any death predominantly attributable to treatment-related toxicities or complications, occurring during or within one month of the completion of therapy), Non-hematologic grades 3 or 4 toxicities attributable to drug (with the specific exclusion of 1) Grade 3 or 4 nausea or vomiting, 2) grade 3 transaminases (AST/ALT) elevations which return to < grade 1 prior to the time of the next treatment course, 3) grade 3 or 4 fever or infection, and 4) Grade 3 mucositis.) and Hematologic toxicity (Delay of >2 weeks in the start of re-induction cycle 2 or in hematologic recovery after cycle 2 secondary to severe myelosuppression, infection, or sepsis.) (NCT00381940)
Timeframe: After 2 cycles and 4 cycles

InterventionParticipants (Count of Participants)
Induction Success Rate (After 2 cycles)Induction Success Rate (After 4 cycles)
Treatment (Ifosfamide, Vinorelbine, Bortezomib)1912

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Overall Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR (NCT00381940)
Timeframe: After 2 cycles and 4 cycles

InterventionParticipants (Count of Participants)
Overall Response Rate (After 2 cycles)Overall Response Rate (After 4 cycles)
Treatment (Ifosfamide, Vinorelbine, Bortezomib)1912

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Survival Measures

"Reports the survival measures:~Freedom from progression (FFP)~Event-free survival (EFS)~Overall survival (OS)~EFS and OS were estimated by Kaplan-Meier method~Progression was defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions" (NCT00388349)
Timeframe: 2 years

Interventionpercentage of patients (Number)
Freedom from Progression (FFP)Event-Free Survival (EFS)Overall Survival (OS)
1250 mg/m2 Gemcitabine + High-dose Chemotherapy + PBSC Rescue716783

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Relapse Post-transplant

Reports the percentage of participants that experienced relapse post-transplant. (NCT00388349)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine + High-dose Chemotherapy + PBSC Rescue29

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Pulmonary Toxicity (BCNU Pneumonitis)

Pulmonary toxicity as assessed by the number of participants that experience BCNU pneumonitis, ie, pneumonitis due to carmustine (BCNU). (NCT00388349)
Timeframe: 2 years

Interventionparticipants (Number)
Gemcitabine + High-dose Chemotherapy + PBSC Rescue26

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Overall Survival (OS)

Reports the percentage of participants surviving 6 months after PBSC infusion (transplant). (NCT00388349)
Timeframe: 2 years

Interventionpercentage of participants (Number)
Gemcitabine + High-dose Chemotherapy + PBSC Rescue87

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Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

Reported as the number of Phase 1 participants by gemcitabine dose that experienced non-hematologic toxicity, ie, drug-related adverse events. (NCT00388349)
Timeframe: 6 months

Interventionparticipants (Number)
1250 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue0
1500 mg/m2 Gemcitabine + HD Chemo + PBSC Rescue3

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Toxicity Profile

Toxicities are assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 3.0. Toxicities are reported as the number of patients who experienced grade 3 or grade 4 adverse events after receiving at least one dose of on-study treatment. (NCT00391586)
Timeframe: 28 days after last on-study treatment

Interventionparticipants (Number)
AcneAnorexiaConfusionDehydrationDiarrheaDyspneaFatigueNasal hemorrhageInsomniaKidney painLymphocyte count decreasedMuscle weaknessNeutrophil count decreasedDesquamating rashSyncopeThrombosis (clotting)
Erlotinib Followed by Chemotherapy1111238111112111

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Last Quantifiable Drug Concentration (Clast)

(NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionng/mL (Mean)
ANX-5300.819
Navelbine0.824

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Maximum Observed Plasma Concentration (Cmax)

(NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionng/mL (Mean)
ANX-530227
Navelbine223

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Mean Residence Time (MRTinf)

MRT = (AUMCinf)/(AUCinf) (NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionhours (Mean)
ANX-53035.39
Navelbine31.31

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Observed Elimination Rate Constant Associated With the Terminal Portion of the Curve (λ z)

Estimated via linear regression of the time versus log concentration (NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionhr-1 (Mean)
ANX-5300.0160
Navelbine0.0187

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Observed Terminal Elimination Half-Life (t1/2)

t1/2 = [ln(2)/λ z] (NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionhours (Mean)
ANX-53046.50
Navelbine40.48

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Area Under the Plasma Concentratio-Time Curve From Time 0 to the Time of the Last Measurable Concentration (AUClast)

Determined Using the Linear Trapezoidal Rule (NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionhr*ng/mL (Mean)
ANX-530757.8
Navelbine716.1

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Percentage of AUCinf Based on Extrapolation (AUCextrap)

(NCT00432562)
Timeframe: 0-144 hours post-dose

Intervention% of participants (Mean)
ANX-5306.23
Navelbine4.72

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Time of Last Measurable Concentration (Tlast)

(NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionhours (Mean)
ANX-530141.83
Navelbine141.79

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Time to Reach Maximum Observed Plasma Concentration (Tmax)

(NCT00432562)
Timeframe: 0-144 hours post dose

Interventionhours (Mean)
ANX-5300.35
Navelbine0.34

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Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf)

AUCinf = AUClast + (Clast/lamda z) (NCT00432562)
Timeframe: 0-144 hours post-dose

Interventionhr*ng/mL (Mean)
ANX-530810.1
Navelbine718.5

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Response Rate (RR)

Number of participants per response category. Response to treatment was determined according to Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. (NCT00499109)
Timeframe: 6 months

,
Interventionparticipants (Number)
Complete Response (CR)Partial Response (PR)
C. Standard of Care Control Arm031
E. Dual Agent Chemotherapy064

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Overall Survival (OS)

OS at 12 months, determined from the date of randomization. The time interval from randomization to the date of death was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the overall survival. (NCT00499109)
Timeframe: 12 months

Interventionestimated percentage of participants (Number)
E. Dual Agent Chemotherapy46.1
C. Standard of Care Control Arm46.6

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Progression Free Survival (PFS)

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. The data of first documented disease progression or death, as defined by Response Evaluation Criteria In Solid Tumors (RECIST), was recorded, and the time interval from randomization to that date was calculated for each patient and used to generate Kaplan-Meier survival estimates and to calculate the PFS at 6 months. (NCT00499109)
Timeframe: 6 months

Interventionestimated percentage of participants (Number)
E. Dual Agent Chemotherapy52
C. Standard of Care Control Arm56.5

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Number of Participants With Complete Pathologic Response.

"Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR.~Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response." (NCT00503750)
Timeframe: assess at 8 weeks

Interventionparticipants (Number)
Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine13

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Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.

"Complete clinical response (CCR): complete disappearance of all measurable malignant disease. No new malignant lesion, disease-related symptoms or evidence of non-evaluable disease.~Partial response (PR): Reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.~Stable disease (SD): For bidimensionally measurable disease, no decrease or <25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions." (NCT00503750)
Timeframe: clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op

Interventionparticipants (Number)
Complete ResponsePartial ResponseStable Disease
Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine2070

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Area Under the Curve

Pharmacokinetics were evaluated in patients with sufficient dosing information and plasma concentration versus time data over 0-24 hours following vinorelbine infusion to allow calculation of area-under-the-curve from zero to 24 hours after infusion (AUC0-24). Furthermore, dose-normalization of AUC0-24 to the standard 30 mg/m2 dose was performed to allow evaluation of the relationship between liver function and AUC of vinorelbine. Data were collected at 0 and 24 hours post-dose. (NCT00540982)
Timeframe: 2 months post treatment

Interventionng/ml x hr (Median)
Normal271
Mild537
Moderate341
Severe324

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Number of Participants With Grade 3 and 4 Toxicities

Grade 3 & 4 toxicities at least possible related to study drugs during any cycle of treatment. Toxicity graded according to Common Terminology Criteria for Adverse Events version 2.0. (NCT00540982)
Timeframe: 3 weeks after the stop of treatment

,,,,,,,
InterventionParticipants (Count of Participants)
AnemiaLymphopeniaNeutropeniaThrombocytopeniaAnorexia/weight lossAscitesCerebrovascular ischemiaConfusionConstipationDehydrationDiarrheaDyspneaEdemaFatigueGeneralized weaknessHallucinationsHypotensionHypertensionInfection (including febrile neutropenia)ThromboembolismAbnormal LFTsHypercalcemiaHyperglycemiaHyperkalemiaHypophosphatemiaNeuropathyPainPetechiae/purpuraPulmonary hemorrhageElevated INRHypokalemiaHyponatremia
Mild (15mg/m2)00100000000000000000000000000000
Mild (20mg/m2)20200000000000000000001000000000
Mild (30mg/m2)00100000000000000000101000000000
Moderate (15mg/m2)31411010110000000012310110000000
Moderate (30mg/m2)10700000020000011120100010100030
Normal (30mg/m2)11400000011001001000003000100000
Severe (20mg/m2)11421101000111201030301011111121
Severe (7.5mg/m2)00000001100001001000302000000000

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2-Year Overall Survival in Patients Treated for NSCLC

Overall survival time was defined as the time from initiation of study treatment to the date of death as a result of any cause. Time was censored at the date of the last follow-up visit for patients who were still alive. The two-year overall survival rate is a percentage, representing the fraction of treated patients who, after two years, are alive (NCT00545948)
Timeframe: 2 years

Interventionpercentage of treated patients (Number)
Treatment81.81

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Percentage of Patients With Completely Resected NSCLC Tumors That Can Be Analyzed and Used to Direct Adjuvant Chemotherapy

The percentage of patients with completely resected NSCLC tumors who had successful genomic analysis and assigned to treatment among patients. All 31 patients enrolled in the study had completely resected tumors. These tumors included a mixture of squamous and non-squamous histologies as indicated the original protocol. However, an amendment dated January 25, 2010 limited eligibility to patients with non-squamous disease. Given that only 5 patients were accrued into the study after this amendment, results reported will consider all histologies. (NCT00545948)
Timeframe: 4 years

InterventionPercentage of participants (Number)
All Registered Patients77.4

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2-Year Progression-Free Survival Rate in Patients With Completely Resected Stage IB, II, or IIIA NSCLC

Progression-free survival time was defined as the time from initiation of study treatment to the first date of disease progression or death as a result of any cause. Progression was defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time was censored at the date of the last follow-up visit for patients who were still alive and have not progressed. The two-year progression free survival rate is a percentage, representing the fraction of treated patients who, after two years, are disease free or alive. (NCT00545948)
Timeframe: 2 years

Interventionpercentage of treated patients (Number)
Treatment63.64

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Disease Relapse or Progression as Measured by CT Scan or PET

(NCT00574496)
Timeframe: 3 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma34.3

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Overall Survival

(NCT00574496)
Timeframe: up to 8 years

Interventionmonths (Median)
High-Risk or Relapsed Hodgkin Lymphoma70.3

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Progression-free Survival at 1 Year

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT00574496)
Timeframe: 1 year

Interventionproportion of progression-free pts (Number)
High-Risk or Relapsed Hodgkin Lymphoma33.3

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Progression-free Survival (PFS)

Time from randomization to date of documented response of progressive disease (PD) as assessed according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. (NCT00597116)
Timeframe: Assessed from baseline to 12 months.

InterventionMonths (Median)
Vandetanib1.8
Vinorelbine3.8

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Overall Survival (OS)

(NCT00597116)
Timeframe: Assessed from baseline to 12 months.

InterventionMonths (Median)
Vandetanib7.8
Vinorelbine6.4

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Number of Participants With Objective Response.

Objective response is defined as having a complete response (CR) or a partial response (PR) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. (NCT00597116)
Timeframe: Assessed at 2 months.

InterventionParticipants (Number)
Vandetanib0
Vinorelbine0

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Number of Participants With Disease Control.

Disease control is defined as having a complete response (CR), a partial response (PR) or stable disease (SD) according to the modified RECIST criteria for assessment of response in malignant pleural mesothelioma. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour measurement. A confirmed response requires a repeat observation on two occasions 4 weeks apart. PD is defined as an increase of at least 20% in the total tumour measurement over the nadir measurement, or the appearance of one or more new lesions. Patients with SD are those who fulfill the criteria for neither PR nor PD. (NCT00597116)
Timeframe: Assessed at 2 months.

InterventionParticipants (Number)
Vandetanib0
Vinorelbine5

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Incidence of >Grade 3 Treatment-Emergent Non-hematological Adverse Events

Toxicity will be assessed at the 0.05 two-sided level of significance. The Common Terminology Criteria for Adverse Events Version 3.0 will be used to grade the severity of adverse events. (NCT00602797)
Timeframe: Up to week 17

InterventionParticipants (Count of Participants)
Treatment6

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Progression-free Survival.

Time from first therapy until first documentation of clinical progression, relapse or death. Progression was defined as per RECIST v1.0 criteria as an at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions. The Kaplan-Meier method will be used to estimate time to event distributions. (NCT00602797)
Timeframe: Time from first therapy until first documentation of clinical progression, relapse or death assessed up to 5 years

InterventionMonths (Median)
Treatment Group7.8

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Response Rate Based on RECIST Criteria

The measurement of effect will be based on the Response Evaluation Criteria In Solid Tumors criteria. Response rate is the sum of complete and partial responses. Complete Response is defined as the disappearance of all target lesions. Partial Response is defined as an at least 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter (NCT00602797)
Timeframe: Up to 5 years

InterventionParticipants (Count of Participants)
Treatment Group5

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Progression Free Survival

Progression-Free Survival will be defined the percentage of participants alive and progression-free at median follow up of 25 months. Patients will be routinely followed for disease progression and those who die without a reported prior progression will be considered to have progressed on the day of their death. Patients who did not progress or die will be censored at the day of their last treatment assessment. Patients who have not received study regimen or did not have on-study treatment assessments will be censored on the day they entered the trial. Patients who receive chemotherapy for reasons other than documented progression of disease or clinical progression without documented progression will be censored on the earliest date of subsequent therapy (NCT00632827)
Timeframe: Up to 3 years

Interventionpercentage of partcipants (Number)
Treatment Plan65

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Complete Response Rate

The complete response rate will be defined as the total number of patients who have defined complete response using study regimen (intensive induction therapy/progressive chemotherapy/stem cell rescue), divided by the number of patients entered in the trial using response-evaluable patients. (NCT00632827)
Timeframe: Up to 3 years

InterventionParticipants (Count of Participants)
Treatment Plan14

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Median Time to Response

The time to response is measured from the time measurement criteria are met for complete response or partial response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) in months. (NCT00632827)
Timeframe: Up to 2 years

Interventionmonths (Median)
Treatment Plan3.0

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Overall Survival Rate

Overall Survival will be defined the percentage of participants alive at median follow up of 25 months. If the patient is lost to follow-up, survival will be censored on the last date the patient was known to be alive. The analysis is expected to occur up to 60 months after the first patient is entered the trial. (NCT00632827)
Timeframe: Up to 5 years

Interventionpercentage of participants (Number)
Treatment Plan75

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Neurotoxicity Assessment at Cycle 4

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 16 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at completion of cycle 4 of their chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm14.5
Multivitamin + Vitamin B12 + Vitamin B614.5
Heavy Metals Group: Multivitamin (MV) Arm8.71
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm7.05
Vinca Alkaloids Group: Multivitamin (MV) Arm17.5
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm9.22

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Change in Neurotoxicity Assessment Between Cycle 4 and Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline, cycle 2, and cycle 4 of their chemotherapy treatment. Change in neurotoxicity scores from baseline to the completion of 4 cycles are reported as the mean total score for all patients. (NCT00659269)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm7.0
Taxane Group: MV + Vitamin B12 + Vitamin B67.2
Heavy Metals Group: Multivitamin (MV) Arm3.9
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.7
Vinca Alkaloids Group: Multivitamin (MV) Arm11.8
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm7

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Neurotoxicity Assessment at Baseline

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to fill out at baseline (prior to chemotherapy treatment) and the mean total score for all patients is reported. (NCT00659269)
Timeframe: At study start; prior to treatment (week 0)

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm8.5
Taxane Group: MV + Vitamin B12 + Vitamin B67.3
Heavy Metals Group: Multivitamin (MV) Arm5.23
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm4.58
Vinca Alkaloids Group: Multivitamin (MV) Arm6.80
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm2.08

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Neurotoxicity Assessment at Cycle 2

Neurotoxicity is evaluated using The Functional Assessment of Cancer Therapy-Taxane (FACT-Tax) questionnaire. FACT-Tax is a validated, self-reported instrument. The questionnaire consists of 11 questions and possible scores for each question range from 0 (no neurotoxicity symptoms) to 4 (worst possible neurotoxicity symptoms). The total score for any patient can therefore range from 0 to 44. The questionnaire is given to patients to complete at completion of cycle 2 of chemotherapy treatment and the mean total score for all patients is reported. (NCT00659269)
Timeframe: 2 weeks

Interventionunits on a scale (Mean)
Taxane Group: Multivitamin (MV) Arm13.0
Taxane Group: MV + Vitamin B12 + Vitamin B612.0
Heavy Metals Group: Multivitamin (MV) Arm9.7
Heavy Metals Group: MV + Vitamin B12 + Vitamin B6 Arm8.4
Vinca Alkaloids Group: Multivitamin (MV) Arm14.56
Vinca Alkaloids Group: MV + Vitamin B12 + Vitamin B6 Arm5.6

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Progression-free Survival

Median progression free survival measured in months (NCT00670982)
Timeframe: 3 years

Interventionmonths (Median)
First Line Treatment9.9
Second Line Treatment7.8

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Objective Response Rate

Objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) and assessed by computed tomography.Complete response (CR), disappearance of all target and non-target lesions; partial response (PR), >/=30% decrease in the sum of longest dimensions of target lesions; objective response rate = CR + PR. (NCT00670982)
Timeframe: 1 year

Interventionpercentage of participants (Number)
First Line Treatment73
Second Line Treatment71

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Proportion of Patients Alive and Without Progression of Disease at 1 Year From Start of Protocol-based Therapy.

Percentage of patients on study without progression at one year after first treatment on study.The date of progression was defined as the earliest occurence of any of the following events: progressive disease by RECIST v1.0, date of initiation of new anticancer therapy, or death due to any cause. New anticancer therapy was defined as the addition or initiation of any new agent for treatment of cancer not including trastuzumab, vinorelbine or bevacizumab. (NCT00670982)
Timeframe: 1 year

Interventionpercentage of participants (Number)
First Line Treatment36
Second Line Treatment29

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To Measure the Number of Cycles

Cycle delivery is a surrogate for drug delivery. Both cycle delivery and drug delivery will be measured in this study. However, cycle delivery (up to 4 cycles) is the common way drug delivery is measured in the literature, and therefore cycle delivery has been chosen as the primary endpoint for this study.Two doses of both docetaxel plus vinorelbine, delivered over 4 weeks, constitutes one cycle. If either drug is discontinued, the subject will remain on study, however that patient will not get credit for completing subsequent cycles of therapy. If the dose of either drug is reduced, the subject will remain on study and get credit for subsequent cycles. (NCT00675597)
Timeframe: 2 years

Interventionparticipants (Number)
Completed 4 cyclesUnable to complete 4 cycles
Docetaxel (Taxotere®) Plus Vinorelbine203

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First Site of Disease Failure in Terms of Relapse

The percentage of participants with first sites of disease failure in terms of relapse within the radiation treatment field, inside the thorax, (outside of the radiation field), or distant disease are presented. Results were summarized using Kaplan-Meier estimates. Some participants relapsed in more than 1 location/site and appear in more than a single category. (NCT00686959)
Timeframe: Baseline to Relapse (Up to 66.6 Months)

,
Interventionpercentage of participants (Number)
Relapsed within the radiation treatment fieldRelapsed inside thorax, outside of radiation fieldRelapsed distant disease
Arm A: Pemetrexed + Cisplatin and TRT37.320.550.0
Arm B: Etoposide + Cisplatin and TRT45.816.345.8

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Adverse Events: The Number of Deaths Per Treatment Group

The number of deaths that occurred while on study drug, the number of deaths due to adverse events (AEs) while on study drug, and the number of deaths due to the study disease (that is, disease progression) while on study drug are presented. In addition, the number of deaths within 30 days of treatment discontinuation, the number of deaths due to AEs within 30 days of treatment discontinuation, and the number of deaths due to study disease within 30 days of treatment discontinuation are presented. For both the deaths due to AEs that occurred on study and for deaths due to AEs that occurred within 30 days of treatment discontinuation, the causality (events assess as possibly related [poss related] to study drug per investigator judgement) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. (NCT00686959)
Timeframe: Baseline through 30 Days Post Study

,
Interventionparticipants (Number)
On study drug (total)On study drug: Due to AEOn study drug: Due to AE poss relatedOn study drug: Due to study diseaseWithin 30 Days of Discontinuation (disc) (total)Within 30 Days of Disc: Due to AEWithin 30 Days of Disc: Due to AE poss relatedWithin 30 Days of Disc: Due to study disease
Arm A: Pemetrexed + Cisplatin and TRT12105210525
Arm B: Etoposide + Cisplatin and TRT64306402

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Percentage of Participants With a Post Baseline Swallowing Diary Score >=4

Participants were provided with a swallowing diary to record issues with swallowing using a 5-point categorical scale: (1) no problems; (2) mild soreness; (3) swallowing solids with some difficulty; (4) inability to swallow solids; and (5) inability to swallow liquids. Participants rated swallowing over the previous 24 hours. The percentage of participants was calculated by dividing the number of with a post baseline swallowing diary score >=4 by total number of participants analyzed, multiplied by 100. No adjustments were made for the number of available assessments nor were any interpolation of missing assessments made. (NCT00686959)
Timeframe: Baseline through 30 Days Post Study

Interventionpercentage of participants (Number)
Arm A: Pemetrexed + Cisplatin and TRT33.8
Arm B: Etoposide + Cisplatin and TRT29.0

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Progression-free Survival (PFS)

Progression-free survival (PFS) time is from baseline to the first date of documented objective progressive disease (PD) or death from any cause. For participants who were not known to have died or to have had objective PD as of the data inclusion cut-off date for a particular analysis, PFS was censored at the date of the last objective progression-free disease assessments. For participants who took any subsequent systemic anticancer therapy prior to progression or death, PFS was censored at the date of the last objective progression-free disease assessment prior to the start date of any subsequent systemic anticancer therapy. PFS time was summarized using Kaplan-Meier estimates. (NCT00686959)
Timeframe: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 66.6 Months)

Interventionmonths (Median)
Arm A: Pemetrexed + Cisplatin and TRT11.37
Arm B: Etoposide + Cisplatin and TRT9.76

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Survival Rates at 1, 2, and 3 Years

The probability that survival time is at least 1, 2, or 3 years was summarized using Kaplan-Meier estimates. (NCT00686959)
Timeframe: Baseline to Date of Death from Any Cause (Up to 71.4 Months)

,
Interventionprobability of survival (Number)
1 year (12 months)2 years (24 months)3 years (36 months)
Arm A: Pemetrexed + Cisplatin and TRT0.760.520.40
Arm B: Etoposide + Cisplatin and TRT0.770.520.37

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Objective Response Rate (Complete Response [CR] + Partial Response [PR])

Overall response rate (ORR) is the best response of CR or PR as classified by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1) guidelines. CR is defined as the disappearance of all target and non-target lesions, normalization of tumor marker level of non-target lesions, and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100. (NCT00686959)
Timeframe: Baseline to Measured Progressive Disease (Up to 7 Months)

Interventionpercentage of participants (Number)
Arm A: Pemetrexed + Cisplatin and TRT35.9
Arm B: Etoposide + Cisplatin and TRT33.0

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Overall Survival

Overall survival (OS) time is from baseline to the date of death from any cause. For participants not known to have died as of the data cut-off date, OS time was censored at the last contact date the participant was known to be alive prior to the data cut-off date. OS was summarized using Kaplan-Meier estimates. (NCT00686959)
Timeframe: Baseline to Date of Death from Any Cause (Up to 71.4 Months)

Interventionmonths (Median)
Arm A: Pemetrexed + Cisplatin and TRT26.81
Arm B: Etoposide + Cisplatin and TRT24.97

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Duration Of Response

Duration of response for subjects who had complete or partial response from first response to disease progression, death or last assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. (NCT00706030)
Timeframe: From start date of response to first PD/death, up to four years and six months.

Interventionweeks (Median)
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib52.7
Neratinib 20 mg + Vinorelbine 25 mg/m² - Prior Lapatinib77.7

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Maximum Tolerated Dose

Maximum Tolerated Dose (MTD) of Neratinib in combination with vinorelbine in subjects with advanced solid tumors. (NCT00706030)
Timeframe: From Day 1 to Day 21.

Interventionmg (Number)
Part 1240

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Overall Response Rate

Overall Response Rate (ORR), subjects with CR or PR by independent review in subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. (NCT00706030)
Timeframe: From first dose date to progression or last tumor assessment, up to four years and six months.

Interventionpercentage of participants (Number)
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib35.9
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib13.3

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Progression-Free Survival

Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), as at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions. (NCT00706030)
Timeframe: From first dose date to progression or death, up to four years and six months.

Interventionweeks (Median)
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib48.0
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib22.7

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Clinical Benefit Rate

Percentage of participants with partial response (PR) or complete response (CR) or stable disease > 24 weeks by independent assessment for subjects with ErbB-2-positive breast cancer treated at the MTD of neratinib in combination with vinorelbine, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions. (NCT00706030)
Timeframe: From first dose date to progression or last tumor assessment, up to four years and six months.

Interventionpercentage of participants (Number)
Neratinb 240 mg + Vinorelbine 25 mg/m² - No Prior Lapatinib64.1
Neratinib 240 mg + Vinorelbine 25 mg/m² - Prior Lapatinib40.0

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Duration of Response, as Assessed by the Investigator

Duration of response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the first documented evidence of CR or PR until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to any cause, if sooner. (NCT00709618)
Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Interventionweeks (Median)
Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg32

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Number of Participants With Overall Response (OR), as Assessed by the Investigator

OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as a reference the baseline sum LD) as assessed by the investigator as the best OR. The best OR is the best response recorded from the start of treatment until disease progression (PD: a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest sum LD recorded since treatment started or the appearance of >=1 new lesions)/recurrence. (NCT00709618)
Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Interventionparticipants (Number)
Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg18

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Progression-Free Survival (PFS), as Assessed by the Investigator

PFS is defined as the time from the start of treatment until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of 1 or more new lesions. (NCT00709618)
Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Interventionweeks (Median)
Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg24.1

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Time to Progression (TTP), as Assessed by the Investigator

TTP is defined as the time from the start of treatment until the earliest date of disease progression (a >=20% increase in the sum of the LD of TLs, taking as a reference the smallest LD recorded since treatment started or the appearance of >=1 new lesions) or death due to breast cancer, if sooner. (NCT00709618)
Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Interventionweeks (Median)
Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg24.1

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Time to Response, as Assessed by the Investigator

Time to response, for the subset of participants who had a confirmed CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the baseline sum LD), is defined as the time from the start of treatment until the first documented evidence of CR or PR (whichever status was recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed. (NCT00709618)
Timeframe: From the start of study medication until disease progression, assessed every 8 weeks for up to 2 years

Interventionweeks (Median)
Vinorelbine 20 mg/m^2 Plus Lapatinib 1500 mg7.5

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Objective Response Rate

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response Rate defined as percentage of patients achieving a Best Response of either CR or PR. (NCT00828074)
Timeframe: After 2 cycles of treatment, up to 2 years.

Interventionpercentage of participants (Number)
Dose Level II - Vinorelbine 20 mg/m^210

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Overall Survival

Estimated using the product-limit method of Kaplan and Meier. (NCT00828074)
Timeframe: Until death from any cause, up to 5 years.

InterventionMonths (Median)
Dose Level II - Vinorelbine 20 mg/m^215.4

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Progression-free Survival

Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00828074)
Timeframe: Until disease progression, up to 5 years.

InterventionMonths (Median)
Dose Level II - Vinorelbine 20 mg/m^24.1

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Progression-free Survival Rate at 4 Months

Estimated using the product-limit method of Kaplan and Meier.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT00828074)
Timeframe: 4 months following the last course of treatment

Interventionpercentage of participants (Number)
Dose Level II - Vinorelbine I.V. 20 mg/m^244

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Toxicity Profile

Number of Participants with Treatment-Related Grade 3 & 4 Toxicities for Sorafenib and Vinorelbine Combination (NCT00828074)
Timeframe: 28 days following the last course of treatment

Interventionparticipants (Number)
AnemiaLeukopeniaNeutropeniaThrombocytopeniaAlkalosisCellulitisCoughDiarrheaFatigueGenital abscessHand-foot toxicityHiccupsHigh glucose levelHypertensionHypokalemiaHyponatremiaInfection (NOS)Low phosphatePulmonary embolusMyalgiaPain (NOS)PhlebitisSensory neuropathySomnolenceTransaminases/alkalineUrinary tract infection
Phase I & II2161611113517113121311311111

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Number of Participants With at Least One Dose Limiting Toxicity in Phase I

Dose Limiting Toxicity (DLT) defined as any treatment-related grade 3 or greater non-hematologic toxicity (excluding alopecia, controllable nausea and vomiting, and serum triglycerides < 1,500 mg/dL which recover within 1 week), grade 4 or greater thrombocytopenia, grade 4 or greater febrile neutropenia requiring hospitalization, or treatment delay of > 2 weeks as a result of unresolved toxicity during the first cycle of therapy. (NCT00828074)
Timeframe: 4 weeks from start of treatment, up to 2 years

Interventionparticipants with DLTs (Number)
Phase I: Dose Level 1 - Vinorelbine at 20mg/m^20
Phase I: Dose Level 2 - Vinorelbine at 25mg/m^23

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Randomized Part: Best Overall Response (BOR) Rate

The BOR rate is defined as the percentage of participants having achieved confirmed complete response (CR) or partial response (PR) as the best overall response, based on radiological assessments (based on response evaluation criteria in solid tumors [RECIST]) as assessed by Independent Review Committee (IRC): CR = disappearance of all target lesions; PR = at least 30% decrease in the sum of the longest diameter of target lesions. (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionpercentage of participants (Number)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy37.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy27.5
Randomized Part: Cetuximab + Chemotherapy29.8

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Randomized Part: Overall Survival (OS) Time

The OS time is defined as the time (in months) from randomization to death or last day known to be alive. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier. (NCT00842712)
Timeframe: Time from randomization until death or last day known to be alive, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy13.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy13.6
Randomized Part: Cetuximab + Chemotherapy9.7

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Randomized Part: Progression Free Survival (PFS) Time - Independent Read

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Independent Read is the assessment of all imaging centrally by an Independent Review Committee (IRC). (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy6.2
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cetuximab + Chemotherapy5.0

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Randomized Part: Progression Free Survival (PFS) Time - Investigator Read

The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. Investigator read is the assessment of all imaging by the treating physician at the local trial site. (NCT00842712)
Timeframe: Time from randomization until disease progression, death or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date, (26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy5.6
Randomized Part: Cetuximab + Chemotherapy5.3

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Randomized Part: Time to Treatment Failure

Time to treatment failure was defined as the time from first administration of trial treatment until the date of the first occurrence of one of the events defining treatment failure: Progressive Disease (PD) assessed by the investigator, discontinuation of treatment due to PD, discontinuation of treatment due to an adverse event (AE), start of any new anticancer therapy, or withdrawal of consent or death within 60 days of the last tumor assessment or first administration of trial treatment. Time to treatment failure was assessed according to modified World Health Organization (WHO) criteria by Independent Review Committee (IRC). (NCT00842712)
Timeframe: Time from randomization until treatment failure or last tumor assessment, reported between day of first participant randomized, that is, Feb 2009 until cut-off date,(26 Jun 2013)

Interventionmonths (Median)
Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy4.4
Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy2.8
Randomized Part: Cetuximab + Chemotherapy4.2

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Safety run-in Part: Number of Participants With Dose Limiting Toxicities (DLTs)

(NCT00842712)
Timeframe: Up to Week 3

Interventionparticipants (Number)
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem0
Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin0
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem0
Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin0

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Local Failure Free Survival

Local failure free survival 9 month after first RT treatment measured by CT/FDG-CT (NCT00887783)
Timeframe: 9 months

Interventionmonths (Median)
B: 66Gy/33F+Navelbine Oral 150 mg q3w9.4
A: 60Gy/30F+Navelbine Oral 150 mg q3w9.9

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Disease Free Survival

Disease free survival, death of any cause (NCT00887783)
Timeframe: 72 months

InterventionMonths (Median)
B: 66Gy/33F+Navelbine Oral 150 mg q3w8.4
A: 60Gy/30F+Navelbine Oral 150 mg q3w8.8

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Number of Participants Who Experienced Early Toxicity to Concurrent Vinorelbine and Radiotherapy

(NCT00887783)
Timeframe: 9 months

,
Interventionparticipants (Number)
Dysphagia g3+Pulmonary toxLeucopenia g3+
A: 60Gy/30F+Navelbine Oral 150 mg q3w6113
B: 66Gy/33F+Navelbine Oral 150 mg q3w7144

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Overall Survival

Overall survival, death of any cause (NCT00887783)
Timeframe: 72 months

InterventionMonths (Median)
B: 66Gy/33F+Navelbine Oral 150 mg q3w25.3
A: 60Gy/30F+Navelbine Oral 150 mg q3w23.3

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Area Under the Concentration-time Curve of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing

Interventionng*h/mL (Geometric Mean)
in Presence of Afatinib258
in Absence of Afatinib334

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Area Under the Concentration-time Curve of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing

Interventionng*h/mL (Geometric Mean)
in Presence of Afatinib512
in Absence of Afatinib655

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Number of Patients With Objective Response (OR)

OR is defined as confirmed complete response and confirmed partial response (PR) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). (NCT00906698)
Timeframe: From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Interventionparticipants (Number)
Afatinib 20mg With Vinorelbine i.v.0
Afatinib 40mg With Vinorelbine i.v.0
Afatinib 50mg With Vinorelbine i.v.0
Afatinib 20mg With Vinorelbine Per os0
Afatinib 40mg With Vinorelbine Per os3
Afatinib 50mg With Vinorelbine Per os0

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Progression-free Survival (PFS)

PFS was defined as the time from the first dose of study medication to the occurrence of tumour progression or death, whichever came first. It was assessed according to RECIST 1.0. Median time results from unstratified Kaplan-Meier estimates. (NCT00906698)
Timeframe: From first dose of study medication to the occurrence of progression or death whichever came first, up to 44 months.

Interventionweeks (Median)
Afatinib 40mg With Vinorelbine i.v.14.6
Afatinib 40mg With Vinorelbine Per os15.9

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Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing

Interventionhours (Median)
in Presence of Vinorelbine i.v.3.16
in Absence of Vinorelbine i.v.2.00

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Time From Dosing to the Maximum Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing

Interventionhours (Median)
in Presence of Vinorelbine Per os3.54
in Absence of Vinorelbine Per os3.00

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Best Percentage Change in Tumour Size

Best percentage change in tumour size was the best percentage change in the sum of diameters of target lesions and was calculated as (minimum sum of diameters post baseline - sum of diameters at baseline)/sum of diameters at baseline. Negative values indicate a decrease, positive values an increase. (NCT00906698)
Timeframe: Screening and every 8 weeks after starting of treatment, up to 44 weeks.

Interventionpercentage change in tumour size (Mean)
Afatinib 20mg With Vinorelbine i.v.-5.65
Afatinib 40mg With Vinorelbine i.v.-7.51
Afatinib 50mg With Vinorelbine i.v.-24.10
Afatinib 20mg With Vinorelbine Per os25.89
Afatinib 40mg With Vinorelbine Per os-1.36
Afatinib 50mg With Vinorelbine Per os-10.76

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Duration of Disease Control

Duration of disease control was measured from the start of study treatment to the time of progression or death, whichever occured first. (NCT00906698)
Timeframe: From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Interventiondays (Median)
Afatinib 20mg With Vinorelbine i.v.110
Afatinib 40mg With Vinorelbine i.v.167
Afatinib 50mg With Vinorelbine i.v.168
Afatinib 40mg With Vinorelbine Per os162
Afatinib 50mg With Vinorelbine Per os120

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Duration of Objective Response

The duration of objective response was measured from the time of first documented confirmed CR or PR to the time of progressive disease or death, whichever occured earlier. (NCT00906698)
Timeframe: From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Interventiondays (Median)
Afatinib 40mg With Vinorelbine Per os114

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Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing

Interventionng/mL (Geometric Mean)
in Presence of Vinorelbine i.v.62.0
in Absence of Vinorelbine i.v.42.7

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Maximum Measured Concentration of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 Per os Vinorelbine at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing

Interventionng/mL (Geometric Mean)
in Presence of Vinorelbine Per os55.1
in Absence of Vinorelbine Per os67.2

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Maximum Measured Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25 mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing

Interventionng/mL (Geometric Mean)
in Presence of Afatinib822
in Absence of Afatinib941

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Number of Patients With Best Overall Response

Overall response is defined as complete response, partial response and stable disease and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). Complete response (CR) and partial response (PR) had to be confirmed by a subsequent tumour assessment at least 28 days after the criteria for CR or PR were first met. To confirm a status of stable disease, the duration of stable disease was to be at least 42 days. (NCT00906698)
Timeframe: From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

,,,,,
Interventionparticipants (Number)
Complete responsePartial responseStable diseaseProgressive diseaseMissing
Afatinib 20mg With Vinorelbine i.v.00120
Afatinib 20mg With Vinorelbine Per os00040
Afatinib 40mg With Vinorelbine i.v.001063
Afatinib 40mg With Vinorelbine Per os03672
Afatinib 50mg With Vinorelbine i.v.00501
Afatinib 50mg With Vinorelbine Per os00500

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Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Intravenous Administrations of 25mg/m^2 Vinorelbine in Presence and Absence of Afatinib at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing

Interventionhours (Median)
in Presence of Afatinib0.166
in Absence of Afatinib0.167

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Number of Participants With Dose-limiting Toxicities (DLT)

Number of participants with DLT for the determination of the Maximum Tolerated Dose (MTD). 3+3 dose escalation design. MTD based on DLTs during first treatment course. After MTD was determined, additional patients were included at the MTD in an expansion cohort. (NCT00906698)
Timeframe: 28 days

,,,,,
Interventionparticipants (Number)
First cycle (N=3;6;6;4;6;5)Expansion cohort (N=0;13;0;0;12;0)
Afatinib 20mg With Vinorelbine i.v.0NA
Afatinib 20mg With Vinorelbine Per os0NA
Afatinib 40mg With Vinorelbine i.v.17
Afatinib 40mg With Vinorelbine Per os12
Afatinib 50mg With Vinorelbine i.v.4NA
Afatinib 50mg With Vinorelbine Per os3NA

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Time From Dosing to the Maximum Concentration of Vinorelbine After Single and Multiple Administrations of 60mg/m^2 Vinorelbine Per os in Presence and Absence of Afatinib at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h, 7h and 24h after dosing

Interventionhours (Median)
in Presence of Afatinib1.50
in Absence of Afatinib1.50

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Number of Patients With Disease Control (DC)

DC is defined as confirmed complete response (CR), partial response (PR) and stable disease (SD) and was assessed according to Response Evaluation Criteria in Solid Tumours (RECIST 1.0). (NCT00906698)
Timeframe: From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Interventionparticipants (Number)
Afatinib 20mg With Vinorelbine i.v.1
Afatinib 40mg With Vinorelbine i.v.10
Afatinib 50mg With Vinorelbine i.v.5
Afatinib 20mg With Vinorelbine Per os0
Afatinib 40mg With Vinorelbine Per os9
Afatinib 50mg With Vinorelbine Per os5

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Time to Objective Response

The time to OR was the duration from the first treatment to the time when the measurement criteria for first documented confirmed CR and/or PR were met according to RECIST 1.0 criteria. (NCT00906698)
Timeframe: From first dose of study medication to response measurement, up to 44 months. Tumour assessments were performed at screening, week 8, week 16, week 24, and every 8 weeks thereafter.

Interventiondays (Median)
Afatinib 40mg With Vinorelbine Per os55

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Maximum Measured Concentration of Vinorelbine After Multiple Administrations Per os of 60mg/m^2 in Presence and Absence of Afatinib at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing

Interventionng/mL (Geometric Mean)
in Presence of Afatinib52.8
in Absence of Afatinib65.0

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Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 60mg/m^2 Per os Vinorelbine at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 1h, 1.30h, 2h, 3h, 6h,, 7h and 24h after dosing

Interventionng*h/mL (Geometric Mean)
in Presence of Vinorelbine Per os872
in Absence of Vinorelbine Per os1070

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Area Under the Concentration-time Curve of Afatinib After Multiple Administrations of 40mg Afatinib in Presence and Absence of 25mg/m^2 i.v. Vinorelbine at Steady State

(NCT00906698)
Timeframe: 0.05 hours (h) before dosing at day 1 and 0.10h, 0.30h, 1h, 4h, 7h, 24h and 168h after dosing, 0.05 hours (h) before dosing at day 15 and day 21 and 0.10h, 0.30h, 1h, 2h, 3h, 4h, 6h, 7h and 24h after dosing

Interventionng*h/mL (Geometric Mean)
in Presence of Vinorelbine i.v.892
in Absence of Vinorelbine i.v.683

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Progression Free Survival

"Number of weeks between the date of the first dose of test article and the first date of disease recurrence or progression, or death due to any cause, was documented, censored at the last evaluation, investigator assessment.~Disease Progression (PD) is defined using Response Evaluation Criteria in Solid Tumors Criteria (v1.0), at least a 20% increase in the sum of the longest diameters (LD) of target lesions, taking as reference the nadir LD, meaning the smallest sum of the LDs recorded since the treatment started; or unequivocal progression of existing nontarget lesions; or the appearance of any new lesions." (NCT00958724)
Timeframe: From first dose to last evaluation, up to 40 weeks.

Interventionweeks (Median)
Nera 240 + Vino 2518.2

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Terminal-phase Elimination Half-life

Terminal-phase elimination half-life of Neratinib at day 8 following Administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m^2 to Japanese Subjects with Cancer. (NCT00958724)
Timeframe: Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.

Interventionhr (Mean)
Nera 240 + Vino 2514.37

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Objective Response Rate (ORR)

Proportion of subjects who achieved complete response or partial response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00958724)
Timeframe: From first dose date to progression or last tumor assessment, up to 40 weeks.

Interventionpercentage of participants (Number)
Nera 240 + Vino 2516.7

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Best Overall Response

Best Overall Response in Evaluable Population per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT00958724)
Timeframe: From first dose date to progression or last tumor assessment, up to 40 weeks.

InterventionParticipants (Count of Participants)
Partial ResponseStable Disease >= 6 weeksStable Disease >= 24 weeks
Nera 240 + Vino 25151

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Duration of Objective Response

The duration of objective response was measured from the time at which measurement criteria were met for Complete Response (CR) or Partial Response (PR) (whichever status was recorded first) until the first date on which recurrence or Progressive Disease (PD) was objectively documented, taking as reference for PD the smallest measurements recorded since the treatment started. (NCT00958724)
Timeframe: From first response date to PD/death, up to 40 weeks.

Interventionweeks (Median)
Nera 240 + Vino 2512.0

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Dose Limiting Toxicity (DLT)

Number of participants experiencing DLT of neratinib in combination with vinorelbine in Japanese patients. (NCT00958724)
Timeframe: From first dose date to 21st day

Interventionparticipants (Number)
Nera 240 + Vino 251

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Area Under the Curve (AUC) Tau

AUC of Neratinib at day 8 following administration of Neratinib 240 mg in combination with Vinorelbine 25 mg/m^2 to Japanese Subjects with Cancer. (NCT00958724)
Timeframe: Predose, and hour 1, 2, 4, 6, 8 and 24 on day 8.

Interventionng*hr/mL (Mean)
Nera 240 + Vino 251330

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Clinical Benefit Rate (CBR)

CBR was defined as the percentage of participants whose best overall response, according to RECIST, was either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD; PD = At least a 20% increase in the sum of the longest diameter of all measured target lesions, taking as reference the smallest sum of longest diameter of all target lesions recorded at or after baseline. (NCT01007942)
Timeframe: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months

InterventionPercentage of participants (Number)
Everolimus + Vinorelbine + Trastuzumab59.2
Placebo + Vinorelbine + Trastuzumab53.3

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Vinorelbine Blood Concentrations by Leading Dose and Time Point

Pre-infusion (Cmin) and end of infusion (C2h) vinorelbine PK blood samples were collected at Cycle 2 Day 1. Only valid vinorelbine PK blood samples collected at steady state were used in the analyses. (NCT01007942)
Timeframe: Cycle 2, Day 1

,
Interventionng/ml (Mean)
Pre-infusion - dose (Cmin) (n: 76, 64)End of infusion (Cmax) (n: 58, 49)
Everolimus11.085867.147
Everolimus Placebo0.0611068.51

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Trastuzumab Blood Concentrations by Leading Dose and Time Point

Pre-infusion (Cmin) and end of infusion (C2h) trastuzumab PK blood samples were collected at Cycle 3 Day 1. Only valid trastuzumab PK blood samples collected at steady state were used in the analyses. (NCT01007942)
Timeframe: Cycle 3, Day 1

,
Interventionng/ml (Mean)
Pre-infusion - dose (Cmin) (n: 73, 57)End of infusion (Cmax) (n: 75, 59)
Everolimus23.35164.279
Everolimus Placebo24.52660.576

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PRO: Time to Deterioration in Global Health Status/QoL Domain Score of the European Organization for the Research and Treatment of Cancer (EORTC)-Core Quality of Life Questionnaire (QLQ-C30) (by at Least 10%)

PRO = patient reported outcomes; Time to deterioration (≥ 10% worsening from baseline), in the global health status of EORTC QLQ-C30 scale was done in the 3 functional scales (emotional, physical, & social functioning [EF, PF, & SF]). It contains 30 items & is composed of multi-item scales & single-item measures. These include 5 functional scales (physical, role, emotional, social & cognitive functioning), 3 symptom scales (fatigue, pain, nausea, & vomiting), a global health status/QoL scale, and 6 single items (dyspnea, diarrhea, constipation, anorexia, insomnia & financial impact). Each of the multi-item scale includes a different set of items - no item occurs in more than 1 scale. Each item in the EORTC QLQ-C30 has 4 response categories (1=Not at all, 2= A little, 3= Quite a bit, 4= Very much) with the higher number representing a worse outcome. The global health domain score of the QLQ-C30 questionnaire was pre-specified as the primary QoL domain of interest & disclosed here. (NCT01007942)
Timeframe: Baseline, until disease progression or death up to about 41 months

,
Interventionmonths (Median)
Deterioration - global QoL domain by at least 10%Deterioration in the PF domain by at least 10%Deterioration in the EF domain by at least 10%Deterioration in the SF domain by at least 10%
Everolimus + Vinorelbine + Trastuzumab8.3111.9615.1811.33
Placebo + Vinorelbine + Trastuzumab7.2912.4812.4513.11

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Progressive-free Survival (PFS) Per Investigator Assessment

PFS was defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first. PFS primary analysis performed when 415 events were reached. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. (NCT01007942)
Timeframe: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months

Interventionmonths (Median)
Everolimus + Vinorelbine + Trastuzumab7.00
Placebo + Vinorelbine + Trastuzumab5.78

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Overall Response Rate (ORR)

ORR was defined as the percentage of participants whose best overall response was either complete response (CR) or partial response (PR) according to RECIST version 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT01007942)
Timeframe: Every 6 weeks until disease progression or death which ever occurred first up to about 41 months

InterventionPercentage of participants (Number)
Everolimus + Vinorelbine + Trastuzumab40.8
Placebo + Vinorelbine + Trastuzumab37.2

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Overall Survival (OS)

OS was defined as the time from date of randomization to the date of death from any cause. Final OS was conducted when 388 deaths occurred. (NCT01007942)
Timeframe: Every 3 months until death up to 41 months

Interventionmonths (Median)
Everolimus + Vinorelbine + Trastuzumab23.46
Placebo + Vinorelbine + Trastuzumab24.08

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Everolimus Blood Concentrations by Leading Dose and Time Point

Pre-dose (Cmin) and 2 hours post-dose (C2h) everolimus PK blood samples were collected at Cycle 2 Day 1. Only valid everolimus PK blood samples collected at steady state were used in the analyses. (NCT01007942)
Timeframe: Cycle 2, Day 1

,
Interventionng/ml (Mean)
Pre-dose (Cmin) (n: 7, 32)2 hours post administration (C2h) (n:10, 43)
Everolimus5.65222.005
Everolimus 2.5 mg2.92813.035

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Median Time to Deterioration of the ECOG Performance Status Score

Time to deterioration of ECOG performance status score was summarized at time of assessment. ECOG (Eastern Cooperative Oncology Group)performance scale is a standard criteria for measuring how treatment of cancer impacts their level of functioning in terms of their ability to care for themselves, daily activity, & physical ability (walking, working, etc.). Scale score ranges from 0 to 5, 5 being the worst. ECOG scale index: 0 - Fully active, able to carry on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory & able to carry out work of a light or sedentary nature, e.g., light housework, office work. 2 - Ambulatory & capable of all self-care but unable to carry out any work activities. Up & about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 - Dead (NCT01007942)
Timeframe: baseline, until disease progression or death up to about 41 months

Interventionmonths (Median)
Everolimus + Vinorelbine + Trastuzumab32.66
Placebo + Vinorelbine + Trastuzumab21.55

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Number of Participants With Overall Response (OR), as Assessed by the Investigator in the Randomized Phase

OR is defined as the number of participants achieving either a confirmed complete response (CR: the disappearance of all target lesions [TLs]) or partial response (PR: a >=30% decrease in the sum of the longest diameter [LD] of the TLs, taking as reference the baseline sum LD) as assessed by the investigator as the best OR. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)

Interventionparticipants (Number)
Lapatinib Plus Capecitabine13
Lapatinib Plus Vinorelbine15

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Overall Survival (OS)

OS is defined as the time from randomization to the date of death due to any cause. Participants who had not died were censored at the date of the last adequate tumor assessment at the time of the cut-off. (NCT01013740)
Timeframe: From the date of randomization until death (average of 55 study weeks)

Interventionmonths (Median)
Lapatinib Plus Capecitabine19.4
Lapatinib Plus Vinorelbine24.3

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Progression Free Survival (PFS) in the Randomized Phase

PFS is defined as the time from randomization until the earliest date of disease progression (PD) or death due to any cause, if sooner. PD is defined as at least a 20 % increase in the sum of the longest diameter (LD) of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)

Interventionmonths (Median)
Lapatinib Plus Capecitabine6.2
Lapatinib Plus Vinorelbine6.2

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Duration of Response (DOR) in the Randomized Phase

DOR is defined as the time from the first documented evidence of response (CR or PR) until the first documented sign of disease progression (a >=20% increase in the sum of the LD of TLs, taking as reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion) or death, if sooner. CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of target lesions, taking as a reference the Baseline sum LD. (NCT01013740)
Timeframe: From the time of the first documented confirmed complete or partial response until disease progression or death, if sooner (average of 27 study weeks)

Interventionmonths (Median)
Lapatinib Plus Capecitabine10.8
Lapatinib Plus Vinorelbine6.7

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Time to Response in the Randomized Phase

Time to response is defined as the time from randomization until the first documented evidence of CR (the disappearance of all TLs) or PR (a >=30% decrease in the sum of the LD of the TLs, taking as a reference the basline sum LD) (whichever status is recorded first). When tumor response was confirmed at a repeat assessment, the time to response was taken to be the first time that the response was observed. (NCT01013740)
Timeframe: From randomization until the time of the first documented confirmed CR or PR (average of 27 study weeks)

Interventionweeks (Median)
Lapatinib Plus Capecitabine9.3
Lapatinib Plus Vinorelbine9.4

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Number of Participants With Clinical Benefit (CB) in the Randomized Phase

CB is defined as the the number of participants achieving either a confirmed CR or PR or having stable disease (SD) for at least 24 weeks (i.e., approximately 6 months). CR=the disappearance of all TLs. PR=a >=30% decrease in the sum of the LD of TLs, taking as a reference the Baseline sum LD. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD=at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of >=1 new lesion). Participants with unknown or missing responses were treated as non-responders. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 27 study weeks)

Interventionparticipants (Number)
Lapatinib Plus Capecitabine18
Lapatinib Plus Vinorelbine29

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Number of Participants With Grade 4 and Grade 5 Adverse Events (AE)

An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grades: 0 = no AE or within normal limits; 1 = mild AE; 2 = moderate AE; 3 = severe and undesirable AE; 4 = life-threatening or disabling AE; 5 = death related to AE. (NCT01013740)
Timeframe: From randomization until disease progression, death, or discontinuation from the study (average of 55 study weeks)

,
Interventionparticipants (Number)
Helicobacter gastritis, Grade 4Neutropenia, Grade 4Leukopenia, Grade 4Febrile neutropenia, Grade 4Mucosal inflammation, Grade 4Pulmonary embolism, Grade 4Intestinal obstruction, Grade 5
Lapatinib Plus Capecitabine1000000
Lapatinib Plus Vinorelbine0911111

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Relapse-free Survival

A description, survival to relapse, of patterns of relapse after Doxorubicin, Bleomycin, Vincristine, Etoposide - Prednisone, Cyclophosphamide (ABVE-PC) and risk-adapted radiotherapy. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.82
Group 60.83
Group 70.79

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Safety Analysis and Monitoring of Toxic Death

The primary endpoint for safety analysis and monitoring is toxic death, which is death primarily attributable to treatment. (NCT01026220)
Timeframe: Within 30 days of protocol treatment at median follow-up of 48 months (range: 1 to 70 months).

Interventionparticipants (Number)
Group 10

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Second-event-free Survival

Second event here is defined as any relapse/progression of Hodgkin Lymphoma (HL) or a previously reported second malignant neoplasm (SMN), a new SMN, or death after a first event which can be relapse/progression of HL, SMN, biopsy-proven HL following completion of Consolidation for Slow Early Response (SER) patient, positive bilateral bone marrow biopsy following completion of Consolidation for Stage IV patient, or death. If death occurs as the 1st event, it also counts as the 2nd event. (NCT01026220)
Timeframe: At 4 years from enrollment

,
InterventionProbability of survival (Number)
Group 10.91
Group 20.94
Group 30.88

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Event Free Survival

Survival from enrollment to first event: relapse/progression, second malignancy, or death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.81
Group 20.83
Group 30.78

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Event-free Survival for Rapid Early Response (RER) Positron Emission Tomography(PET)-1 Positive, RER PET-1 Negative

To investigate whether very early response assessment measured by Fluorodeoxyglucose-PET after 1 cycle of chemotherapy identifies a subject cohort that can be studied in future trials and that is distinguishable from currently defined RER after 2 cycles. (NCT01026220)
Timeframe: 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.84
Group 40.82
Group 50.90

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Grade 3 and 4 Non-hematologic Toxicities During Protocol Therapy

The number of patients that experience Common Terminology Criteria (CTC) Version 4 grade 3 or higher non-hematologic toxicity at any time during protocol therapy. (NCT01026220)
Timeframe: During and after completion of study treatment.

Interventionparticipants (Number)
Group 172

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Overall Survival

Survival from enrollment to death. (NCT01026220)
Timeframe: At 3 years from enrollment

InterventionProbability of survival (Number)
Group 10.97
Group 20.97
Group 30.97

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Number of Participants With Hematology Laboratory Abnormalities - Treated Population

Hematology laboratories included hemoglobin, platelets, white blood cell (WBC) count, and absolute neutrophil count (ANC) and values were per CTC grading, 0, 1, 2, 3, 4. On-study laboratory tests were those performed after the start of study drug (from Day 2 of cycle 1) and up to 30 days after the last dose of study drug. WBC normal range: 4.1-12.3 x 10^3 /microliter (µL); platelets normal range: 140-450 x 10^9 /Liter (L); hemoglobin normal range 14-18 grams per deciliter (g/dL); ANC normal range: 2.03-8.36 x 10^9/μL. (NCT01109524)
Timeframe: Day 2 up to 30 days after last dose

Interventionparticipants (Number)
Hemoglobin (low) Grade 1 - 4Hemoglobin (low) Grade 3 or 4Hemoglobin (low) Grade 4Platelets (low) Grade 1 - 4Platelets (low) Grade 3 or 4Platelets (low) Grade 4WBC (low) Grade 1 - 4WBC (low) Grade 3 or 4WBC (low) Grade 4ANC (low) Grade 1 - 4ANC (low) Grade 3 or 4ANC (low) Grade 4
Cetuximab + Cisplatin/Vinorelbine5140191049286473824

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Number of Participants With Liver Function Serum Chemistry Laboratory Abnormalities - Treated Population

ULN=Upper limit of normal among all laboratory ranges. ALT=alanine transaminase; AST=aspartate aminotransferase; ALP=alkaline phosphatase. CTC grade criteria: ALT Grade 1:>ULN 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. AST Grade 1: >ULN - 2.5*ULN; Grade 2: >2.5 - 5.0*ULN; Grade 3: >5.0 - 20.0*ULN; Grade 4: >20.0*ULN. Total bilirubin Grade 1: >ULN - 1.5*ULN; Grade 2: >1.5 - 3.0*ULN; Grade 3: >3.0 - 10.0*ULN; Grade 4: >10.0*ULN. Albumin (low) Grade 1:NCT01109524)
Timeframe: Day 1 up to 30 days after last dose

Interventionparticipants (Number)
Albumin (low) Grade 1 - 4Albumin (low) Grade 3 or 4Total bilirubin (high) Grade 1 - 4 (N=49)Total bilirubin (high) Grade 3 or 4 (N=49)ALT (high) Grade 1 - 4ALT (high) Grade 3 or 4ALP (high) Grade 1 - 4ALP (high) Grade 3 or 4AST (high) Grade 1 - 4AST (high) Grade 3 or 4
Cetuximab + Cisplatin/Vinorelbine37030310260190

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Number of Participants With Grades 3 and 4 Treatment-emergent Adverse Events (AEs) of Special Interest - Treated Population

Special interest AEs: acneform rash, infusion reaction, cardiac adverse event, febrile neutropenia, infection (includes all terms except sepsis), sepsis, interstitial lung disease, renal failure, and thromboembolic events. Except for interstitial lung disease, these were composite terms combining several preferred/other level MedDRA terms (MedDRA version 14.0). Except for Grade (GR)3 and 4 infusion reactions, AE severity were graded per the NCI-CTC, version 3.0: Gr 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Severity of Gr 3 - 4 infusion reactions were: Gr 3=symptomatic bronchospasm, requiring parenteral medication(s), with or without urticaria; allergy-related edema/angioedema; Gr 4=a life-threatening event characterized by the same symptomatology as a Gr 3, complicated by symptomatic hypotension or oxygen saturation 70% or less. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy. (NCT01109524)
Timeframe: Day 1 to 30 days after last dose

Interventionparticipants (Number)
Grade 3-4 acneform rashGrade 3-4 infusion reactionCardiac events Grade 3-4Infection Grade 3-4Sepsis Grade 3-4Renal failure Grade 3-4Thromboembolic events Grade 3-4Interstitial lung disease Grade 3-4Febrile neutropenia Grade 3-4
Cetuximab + Cisplatin/Vinorelbine5239031106

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Number of Participants With Any Treatment-emergent Adverse Events (AEs), Serious Adverse Events (SAEs), Deaths, and AEs Leading to Discontinuation of at Least One Study Drug, - Treated Population

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=medical event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. MedDRA version 14.0. Severity of AEs were graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Day 1 (start of study drug) to 30 days after last dose of any treatment therapy, including cetuximab monotherapy. (NCT01109524)
Timeframe: Day 1 up to 30 days after last dose

Interventionparticipants (Number)
Deaths due to disease progressionDeaths due to Other CausesSAE (any grade)AE (any grade)AE Grade 3 or 4AE that led to Discontinuation of study drug
Cetuximab + Cisplatin/Vinorelbine3238594621

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Number of Participants With Renal Function Serum Chemistry Laboratory Abnormalities - Treated Population

ULN=Upper limit of normal among all laboratory ranges; LLN=Lower limit of normal. CTC grade criteria: Sodium high (H) Grade (Gr) 1:>ULN - 150 millimoles per liter (mmol/L); Gr 2: >150 - 155 mmol/L; Gr 3: >155 - 160mmol/L; Gr 4: >160 mmol/L. Sodium low(L) Gr 1:ULN - 5.5 mmol/L; Gr 2: >5.5 - 6.0 mmol/L; Gr 3: > 6.0 - 7.0 mmol/L; Gr 4: >7.0 mmol/L. Potassium (L) Gr 1: 1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN. Day 1 (start of study drug) to 30 days after last dose of any study drug, including monotherapy. (NCT01109524)
Timeframe: Day 1 up to 30 days after last dose

Interventionparticipants (Number)
Sodium (low) Grade 1 - 4Sodium (low) Grade 3 or 4Sodium (low) Grade 4Sodium (high) Grade 1 - 4Sodium (high) Grade 3 or 4Sodium (high) Grade 4Potassium (low) Grade 1 - 4Potassium (low) Grade 3 or 4Potassium (low) Grade 4Potassium (high) Grade 1 - 4Potassium (high) Grade 3 or 4Potassium (high) Grade 4Serum Creatinine (high) Grade 1 - 4Serum Creatinine (high) Grade 3 or 4Serum Creatinine (high) Grade 4
Cetuximab + Cisplatin/Vinorelbine421801002912110101500

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Objective Response (OR)

"OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.~Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis)~Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.~Other factors which add to the overall response of an imaging timepoint as PR are as below:-~CR in TL, but non-CR/Non-PD in NTL leads to PR~CR in TL, but not evaluated NTL leads to PR~PR in TL, but non-PD NTL or not all evaluated NTL leads to PR" (NCT01125566)
Timeframe: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months)

InterventionPercentage of participants (%) (Number)
Afatinib + Vinorelbine (AV)46.4
Trastuzumab + Vinorelbine (TV)47.0

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Overall Survival (OS)

"OS is defined as time from randomisation to death irrespective of the cause of the death.~For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date." (NCT01125566)
Timeframe: From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.

InterventionMonths (Median)
Afatinib + Vinorelbine (AV)20.17
Trastuzumab + Vinorelbine (TV)29.60

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Progression-free Survival (PFS)

"PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). RECIST is a set of published rules that define when tumors in cancer patients improve (respond), stay the same (stabilize) or worsen (progress) during treatment.~Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.~Progression of disease was determined if at least 1 of the following criteria applied:~At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm~Appearance of 1 or more new lesions~Unequivocal progression of existing non-target lesions" (NCT01125566)
Timeframe: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months

InterventionMonths (Median)
Afatinib + Vinorelbine (AV)5.49
Trastuzumab + Vinorelbine (TV)5.55

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Best RECIST Assessment

"Best RECIST assessment is defined as CR, PR, stable disease (SD), progressive disease (PD) or not evaluable by investigator (RECIST version 1.1).~CR for target lesions (TL): Disappearance of all target lesions.~CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).~PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.~SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.~PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions." (NCT01125566)
Timeframe: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months

,
InterventionPercentage of participants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive Disease (PD)Missing
Afatinib + Vinorelbine (AV)3.343.131.712.69.3
Trastuzumab + Vinorelbine (TV)3.044.026.817.98.3

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Number of Participants (Par.) With Clinical Benefit (CB) at Week 12 and Week 24

Par. with CB are defined as those with complete response (CR), partial response (PR), or stable disease (SD) for >=12 or 24 weeks. Per Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1, CR is defined as the disappearance of all target lesions, PR is defined as a >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD, and SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as a reference the smallest sum LD since the treatment started. (NCT01128543)
Timeframe: Week 12 and Week 24

Interventionparticipants (Number)
Week 12, CRWeek 12, PRWeek 12, SDWeek 24, CRWeek 24, PRWeek 24, SD
Lapatinib 1250 mg and Vinorelbine 20 mg/m^204120410

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Duration of Response

Duration of response was measured in participants who experienced either a complete response or a partial response. Per RECIST, Version 1.1, complete response is defined as the disappearance of all target lesions, and partial response is defined as a >=30% decrease in the sum of the longest diameter of target lesions, taking as a reference the baseline sum longest diameter. (NCT01128543)
Timeframe: From the start of treatment until a complete response or partial response was reached (up to Week 90; average of 21.3 weeks)

Interventionmonths (Median)
Lapatinib 1250 mg and Vinorelbine 20 mg/m^24.6

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Progression-free Survival

Per RECIST, Version 1.1, Progressive Disease is defined as at least a 20% increase in the sum of the LD of target lesions, taking as a reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01128543)
Timeframe: From the start of treatment until disease progression, death, or discontinuation from the study (average of 102.7 months)

Interventionmonths (Mean)
Lapatinib 1250 mg and Vinorelbine 20 mg/m^287.7

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Objective Response Rate (ORR)

ORR was defined as the percentage of patients achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. (NCT01185509)
Timeframe: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).

Interventionpercentage of patients (Number)
Trastuzumab and Vinorelbine - Cohort A18.2
Trastuzumab and Vinorelbine - Main Cohort5.0

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Clinical Benefit Rate (CBR)

CBR was defined as achieving complete response (CR), partial response (PR), or stable disease (SD) for 24 weeks or longer based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PD is at least a 20% increase in sum LD of target lesions (smallest sum LD reference), new lesions, and/or unequivocal progression of existing non-target lesions. Stable disease (SD) is defined as any condition not meeting the above criteria. SD needed to be a minimum 24 weeks in duration (NCT01185509)
Timeframe: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks; Median (range) trt duration was 12 weeks (3-67).

Interventionpercentage of patients (Number)
Trastuzumab and Vinorelbine - Cohort A63.6
Trastuzumab and Vinorelbine - Main Cohort20.0

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Progression-Free Survival (PFS)

PFS based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated. (NCT01185509)
Timeframe: Disease was evaluated radiologically at baseline, on trt every 6 weeks (wks) for the first 18 wks and then every 12 wks and within 2 wks off-study; Median follow-up was 2.7 months.

Interventionmonths (Median)
Trastuzumab and Vinorelbine - Cohort A6.9
Trastuzumab and Vinorelbine - Main Cohort2.7

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Baseline Level of Circulating Tumor Cells (CTCs)

CTCs levels were determined based on established methods. (NCT01185509)
Timeframe: Assessed at baseline

Interventioncells per 7.5 ml blood (Median)
Trastuzumab and Vinorelbine - Main Cohort5.5

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Time to Disease Progression

Time to disease progression was defined as the interval between the day of randomization and the first documentation of progressive disease or death. (NCT01196078)
Timeframe: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death

Interventionmonths (Median)
Erlotinib6.66
Vinorelbine3.87

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Percentage of Participants With Disease Progression

Progressive disease was defined using RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01196078)
Timeframe: Day 1 of Cycles 1, 3, and 5 or first documentation of progressive disease or death

Interventionpercentage of participants (Number)
Erlotinib63.16
Vinorelbine58.93

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Changes in Quality of Life as Measured by the FACT Questionnaire

The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, response of down, up or no change were defined as score changes of less than or equal to (≤)2, greater than or equal to (≥)+2, or between these values. (NCT01196078)
Timeframe: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study

,
Interventionunits on a scale (Mean)
PWB, Baseline (n=51,45)PWB, Endpoint (n=51,45)Change in PWB (n=51,45)SWB, Baseline (n=50,45)SWB, Endpoint (n=50,45)Change in SWB (n=50,45)EWB, Baseline (n=52,48)EWB, Endpoint (n=52,48)Change in EWB (n=52,48)FWB, Baseline (n=51,48)FWB, Endpoint (n=51,48)Change in FWB (n=51,48)LCS, Baseline (n=51,47)LCS, Endpoint (n=51,47)Change in LCS (n=51,47)
Erlotinib6.510.84.315.814.3-1.57.97.1-0.812.611.1-1.510.911.20.3
Vinorelbine6.07.81.815.414.4-1.06.26.0-0.213.411.7-1.711.210.7-0.4

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Percentage of Participants With Changes in FACT-L (Lung Symptoms) by Category of Change

The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition). The LCS total score is the sum of the scores from the 7 items, each rated on a five-point scale from 0 (not at all) to 4 (very much). For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. For each FACT-L question, the response status was defined as down, up, or no change if the score at endpoint was smaller (score down), larger than (score up), or the same as (no change) that at baseline. (NCT01196078)
Timeframe: Baseline and End of study

,
Interventionpercentage of participants (Number)
Shortness of breath, Score Down (n=52,48)Shortness of breath, No Change (n=52,48)Shortness of breath, Score Up (n=52,48)Weight loss, Score Down (n=51,47)Weight loss, No Change (n=51,47)Weight loss, Score Up (n=51,47)Clear thinking, Score Down (n=52,48)Clear thinking No Change (n=52,48)Clear thinking, Score Up (n=52,48)Coughing, Score Down (n=52,48)Coughing, No Change (n=52,48)Coughing, Score Up (n=52,48)Hair loss, Score Down (n=52,48)Hair loss, No Change (n=52,48)Hair loss, Score Up (n=52,48)Good appetite, Score Down (n=52,48)Good appetite, No Change (n=52,48)Good appetite, Score Up (n=52,48)Tightness in chest, Score Down (n=52,48)Tightness in chest, No Change (n=52,48)Tightness in chest, Score Up (n=52,48)Easy breathing, Score Down (n=52,48)Easy breathing, No Change (n=52,48)Easy breathing, Score Up (n=52,48)
Erlotinib17.351.930.819.651.029.426.953.819.221.253.825.013.565.421.226.961.511.517.355.826.928.848.123.1
Vinorelbine18.858.322.931.944.723.427.143.829.222.950.027.118.860.420.835.445.818.822.954.222.922.958.318.8

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Percentage of Participants Achieving Disease Control

Disease control was defined as achieving a best overall response of CR, PR, or stable disease (SD) according to RECIST criteria. Participants with tumor assessment unevaluable were viewed as uncontrolled. (NCT01196078)
Timeframe: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year

Interventionpercentage of participants (Number)
Erlotinib71.93
Vinorelbine57.14

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Percentage of Participants Achieving a Best Overall Response of Complete Response (CR) or Partial Response (PR)

CR was defined as disappearance of all target lesions. PR was defined as at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Participants experiencing either a CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) were classified as responders. Participants with tumour assessment unevaluable were viewed as non-responders. (NCT01196078)
Timeframe: Screening, Day 1 of Cycles 3 and 5 and at End of treatment up to 1 year

Interventionpercentage of participants (Number)
Erlotinib22.81
Vinorelbine8.93

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Overall Survival: Time to Event

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no post baseline information were censored at the time of randomization. Overall median time to event was assessed for the population that experienced an event. (NCT01196078)
Timeframe: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment

Interventionmonths (Median)
Erlotinib11.21
Vinorelbine10.36

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Overall Survival: Percentage of Participants With an Progressive Disease or Death

Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last dose and participants with no postbaseline information were censored at the time of randomization. Progressive disease was defined per RECIST as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. (NCT01196078)
Timeframe: Day 1 of Cycles 1 through 6 to date of death or date of last follow-up assessment

Interventionpercentage of participants (Number)
Erlotinib56.14
Vinorelbine48.21

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Duration of Response Among Participants Who Achieved Either a CR or PR

Duration of response was defined similarly for complete and partial responders. Complete response lasted from the date the complete response was first recorded to the date on which progressive disease was first noted or date of death. Partial response lasted from the date of partial response to the date of the first observation of progressive disease or date of death. (NCT01196078)
Timeframe: Screening, Day 1 of Cycles 3 and 5, every 4th cycle during post-study treatment, and every 3 cycles during follow-up

Interventionmonths (Median)
Erlotinib10.89
Vinorelbine8.75

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Percentage of Participants With Changes in Quality of Life as Measured by FACT Questionnaire Scores by Category of Change

The FACT and the FACT-L contain 4 general and 1 lung cancer symptom-specific subscale, including PWB, SWB, EWB, FWB, and the 8-item LCS that assess symptoms commonly reported by participants with lung cancer. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented Worsened'. For PWB, FWB, SWB, and EWB scores and disease-specific subscale score, higher scores indicated a better outcome; a response of down, up, or no change was defined as a score change of ≤ -2 (score down), ≥ +2 (score up), or between these values. (NCT01196078)
Timeframe: Baseline and End of study

,
Interventionpercentage of participants (Number)
PWB, Score Down (n=51,45)PWB, No Change (n=51,45)PWB, Score Up (n=51,45)SWB, Score Down (n=50,45)SWB, No Change (n=50,45)SWB, Score Up (n=50,45)EWB, Score Down (n=52,48)EWB, No Change (n=52,48)EWB, Score Up (n=52,48)FWB, Score Down (n=51,48)FWB, No Change (n=51,48)FWB, Score Up (n=51,48)LCS, Score Down (n=51,47)LCS, No Change (n=51,47)LCS, Score Up (n=51,47)
Erlotinib7.833.358.840.040.020.038.538.523.141.233.325.517.647.135.3
Vinorelbine22.231.146.737.840.022.233.341.725.041.735.422.931.940.427.7

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Quality of Life as Measured by the Functional Assessment of Cancer Therapy (FACT) Questionnaire

The FACT Questionnaire contains 4 general and 1 lung cancer symptom-specific subscale, including Physical Well-Being (PWB), Social/family Well-Being (SWB), Emotional Well-Being (EWB), Functional Well-Being (FWB), and the 8-item Lung Cancer Subscale (LCS) that assess symptoms commonly reported by participants with lung cancer. Each subscale was assessed by a five-point scale from 0 (not at all) to 4 (very much) to determine the quality of life. PWB, SWB and FWB scores ranged from 0-28 and EWB scores ranged from 0-24. LCS scores ranged from 0-36. For subscales of FWB and SWB, questionnaires of EWB, and additional concerns questions, the higher score represented 'Improved'. For other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The FACT-L score ranges from 0 to 136, with higher scores indicating better quality of life. (NCT01196078)
Timeframe: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study

,
Interventionunits on a scale (Mean)
PWB, Baseline (n=56,53)PWB, Cycle 2 (n=52,42)PWB, Cycle 3 (n=41,28)PWB, Cycle 4 (n=37,28)PWB, Cycle 5 (n=30,22)PWB, Cycle 6 (n=25,20)PWB, End of Study (n=52,48)SWB, Baseline (n=55,53)SWB, Cycle 2 (n=52,40)SWB, Cycle 3 (n=42,30)SWB, Cycle 4 (n=37,27)SWB, Cycle 5 (n=28,21)SWB, Cycle 6 (n=26,18)SWB, End of Study (n=52,47)EWB, Baseline (n=57,55)EWB, Cycle 2 (n=52,43)EWB, Cycle 3 (n=42,29)EWB, Cycle 4 (n=37,27)EWB, Cycle 5 (n=29,21)EWB, Cycle 6 (n=25,20)EWB, End of Study (n=52,50)FWB, Baseline (n=56,55)FWB, Cycle 2 (n=51,41)FWB, Cycle 3 (n=41,27)FWB, Cycle 4 (n=37,26)FWB, Cycle 5 (n=29,22)FWB, Cycle 6 (n=25,20)FWB, End of Study (n=51,50)LCS, Baseline (n=56,54)LCS, Cycle 2 (n=50,45)LCS, Cycle 3 (n=42,30)LCS, Cycle 4 (n=37,27)LCS, Cycle 5 (n=28,21)LCS, Cycle 6 (n=26,20)LCS, End of Study (n=52,50)
Erlotinib6.88.18.99.48.89.310.815.915.516.015.915.715.214.47.86.76.47.06.36.57.112.312.913.012.812.711.711.111.010.811.011.310.810.411.1
Vinorelbine6.27.55.77.87.76.47.815.214.716.516.115.117.414.36.55.95.66.05.54.86.013.312.912.911.312.011.411.511.111.210.510.210.09.910.8

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Changes in Quality of Life as Assessed by FACT-L (Lung Symptoms) Questionnaire

The LCS consists of 7 items of the FACT-L (3 items relating to breathing/dyspnea, and 1 item each relating to cough, weight loss, appetite, and cognition) rated on a five-point scale from 0 (not at all) to 4 (very much). The LCS total score is the sum of the scores from the 7 items. For clear thinking and good appetite, the higher score represented 'Improved'; for other subscales and questionnaires, the higher score represented 'Worsened'. Missing data were replaced by the valid post-baseline assessment before. The change of FACT-L subscore was the change from baseline to endpoint. The LCS of FACT-L is an independently validated tool that measures the disease-related symptoms of lung cancer on an overall scale of 0 (most symptomatic) to 28 (asymptomatic). (NCT01196078)
Timeframe: Baseline and Day 1 of Cycles 2, 3, 4, 5, 6 and End of study

,
Interventionunits on a scale (Mean)
Shortness of breath, Baseline (n=52,48)Shortness of breath, Endpoint (n=52,48)Shortness of breath, Change (n=52,48)Weight loss, Baseline (n=51,47)Weight loss, Endpoint (n=51,47)Weight loss, Change (n=51,47)Clear thinking, Baseline (n=52,48)Clear thinking, Endpoint (n=52,48)Clear thinking, Change (n=52,48)Coughing, Baseline (n=52,48)Coughing, Endpoint (n=52,48)Coughing, Change (n=52,48)Hair loss, Baseline (n=52,48)Hair loss, Endpoint (n=52,48)Hair loss, Change (n=52,48)Good appetite, Baseline (n=52,48)Good appetite, Endpoint (n=52,48)Good appetite, Change (n=52,48)Tightness in chest, Baseline (n=52,48)Tightness in chest, Endpoint (n=52,48)Tightness in chest, Change (n=52,48)Easy breathing, Baseline (n=52,48)Easy breathing, Endpoint (n=52,48)Easy breathing, Change (n=52,48)
Erlotinib1.41.60.20.60.70.12.42.2-0.21.31.40.10.30.40.11.91.7-0.31.31.40.11.71.7-0.1
Vinorelbine1.41.3-0.10.80.6-0.22.32.40.11.41.4-0.00.60.4-0.12.01.7-0.41.21.30.11.71.6-0.0

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Number of Patients With Dose Limiting Toxicities (DLTs) During 1st Course

DLTs and Maximum Tolerated Dose (MTD) of afatinib in combination with vinorelbine iv. (MTD = not determined) (NCT01214616)
Timeframe: during 1st course

Interventionparticipants (Number)
Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)0
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)3
Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)0
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)1

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AUC0-∞ for Vinorelbine

area under the blood concentration-time curve of the analyte over the time interval from 0 extrapolated to infinity (NCT01214616)
Timeframe: "predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as with afatinib) and 1st dose (as without afatinib)"

Interventionng*h/mL (Geometric Mean)
Vinorelbine 20 mg/m^2 With Afatinib763
Vinorelbine 20 mg/m^2 Without Afatinib691
Vinorelbine 25 mg/m^2 With Afatinib934
Vinorelbine 25 mg/m^2 Without Afatinib860

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AUCÏ„,ss for Afatinib

area under the plasma concentration-time curve following dose at steady state over the dosing interval Ï„ (NCT01214616)
Timeframe: "pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as with Vinorelbine) and 20th dose (as without Vinorelbine)"

Interventionng*h/mL (Geometric Mean)
Afatinib 20 mg With Vinorelbine329
Afatinib 20 mg Without Vinorelbine404
Afatinib 40 mg With Vinorelbine866
Afatinib 40 mg Without Vinorelbine1010

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Cmax for Vinorelbine

maximum measured blood concentration (NCT01214616)
Timeframe: "predose, 10minutes, 0.5, 1, 4, 7 hours, 23hours55minutes after 2nd or 3rd or 4th dose (as with afatinib) and 1st dose (as without afatinib)"

Interventionng/mL (Geometric Mean)
Vinorelbine 20 mg/m^2 With Afatinib1120
Vinorelbine 20 mg/m^2 Without Afatinib1380
Vinorelbine 25 mg/m^2 With Afatinib1160
Vinorelbine 25 mg/m^2 Without Afatinib1330

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Cmax,ss for Afatinib

maximum measured plasma concentration at steady state (NCT01214616)
Timeframe: "pre-dose, 1, 2, 3, 4, 6, 7hours, and 23hours55minutes after 7th or 14th or 21th dose (as with Vinorelbine) and 20th dose (as without Vinorelbine)"

Interventionng/mL (Geometric Mean)
Afatinib 20 mg With Vinorelbine28.8
Afatinib 20 mg Without Vinorelbine19.6
Afatinib 40 mg With Vinorelbine52.5
Afatinib 40 mg Without Vinorelbine57.1

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Objective Tumour Response

"According to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria and assessed by CT or MRI: Complete Response (CR), disappearance of all target and non-target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR." (NCT01214616)
Timeframe: Pre-treatment, every 8 weeks after start of study treatment, end of treatment

Interventionparticipants (Number)
Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)0
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)0
Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)1
Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)1

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Event Free Survival Probability

Probability of no relapse, secondary malignancy, or death after 1 year in the study. (NCT01222715)
Timeframe: 1 year

InterventionProbability (Number)
Regimen A0.23
Regimen B0.43

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Rate of Dose-Limiting Toxicities

The following events will be considered dose-limiting toxicities (DLTs): Toxicity causing delays > 14 days in delivery of a 21-day cycle of therapy; Grade ≥ 3 mucositis > 3 days duration; Grade ≥ 3 thromboembolic events; Grade ≥ 3 bleeding events; Grade ≥ 3 pulmonary events; Grade ≥ 3 hypertension; Grade 3 hyperglycemia (uncontrolled); Grade ≥ 4 hyperglycemia; Grade ≥ 4 hyperlipidemia (including cholesterol and triglycerides) that does not return to ≤ Grade 2 levels with appropriate medical management within 35 days; Grade ≥ 2 perforation including fistula or leak (gastrointestinal or any other organ); Grade ≥ 3 proteinuria; Grade ≥ 3 cardiac toxicity; Grade ≥ 3 intra-abdominal abscess/infection; Grade ≥ 3 wound complication (wound infection or dehiscence); Grade ≥ 1 Reversible Posterior Leukoencephalopathy Syndrome (RPLS); Grade ≥ 1 Microangiopathy, or Hemolytic-uremic syndrome (HUS) or Thrombotic thrombocytopenic Purpura (TTP). (NCT01222715)
Timeframe: From the date of randomization until a maximum of 12 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.

InterventionPercentage of participants (Number)
Regimen A2
Regimen B21

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Response Rate (CR + PR)

Complete or partial anatomical response rate. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR. (NCT01222715)
Timeframe: From the date of randomization until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities.

InterventionProportion of participants (Number)
Regimen A0.3250
Regimen B0.4737

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Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1

Objective response according to RECIST v1.1. Best overall response of confirmed complete response (CR) or confirmed partial response (PR) recorded since first administration of trial medication and until the earliest of disease progression, death or start of next treatment in each part separately. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR. Percentage of participants with OR along with exact 95% Confidence Interval by Clopper and Pearson is presented. (NCT01271725)
Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

InterventionPercentage of participants (Number)
Afatinib Monotherapy18
Afatinib and Paclitaxel or Vinorelbine Combination Therapy31

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Percentage of Patients With Highest Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 Grade of 3 or Higher

Percentage of patients with highest common terminology criteria for adverse events (CTCAE) version 3.0 Grade of 3 or higher. (NCT01271725)
Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

InterventionPercentage of participants (Number)
Afatinib Monotherapy43
Afatinib and Vinorelbine Combination Therapy62
Afatinib and Paclitaxel Combination Therapy65

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Progression Free Survival (PFS)

Progression Free Survival is defined as the time from the drug start date to the date of 1st disease progression or death for monotherapy and 2nd disease progression or death from the drug start date of the combination therapy for combination therapy'. Median is calculated from the Kaplan-Meier curve. (NCT01271725)
Timeframe: From drug start date in monotherapy to 1st disease progression and drug start date in combination therapy to 2nd disease progression

InterventionDays (Median)
Afatinib Monotherapy86.0
Afatinib and Paclitaxel or Vinorelbine Combination Therapy135.0

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Best Overall Response According to RECIST v1.1 (Regardless of Confirmation)

Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part (without clinical disease assessment) .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. (NCT01271725)
Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

,
InterventionPercentage of participants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive diseaseNot evaluable
Afatinib and Paclitaxel or Vinorelbine Combination Therapy044331013
Afatinib Monotherapy11942289

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Best Overall Response According to RECIST v1.1 (With Confirmation)

Best overall response was assessed according to RECIST version 1.1 and was calculated relative to the baseline of each respective part .Percentage of participants with best overall response along with exact 95% Confidence Interval by Clopper and Pearson is presented. Best overall response was defined as the best response recorded at any time from the first administration of drug to the End of Treatment (EOT). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. (NCT01271725)
Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

,
InterventionPercentage of participants (Number)
Complete response (CR)Partial response (PR)Stable disease (SD)Progressive diseaseNot evaluable
Afatinib and Paclitaxel or Vinorelbine Combination Therapy031461013
Afatinib Monotherapy11645289

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Number of Patient With Possibly Clinically Significant (PCS) Laboratory Values

Number of patient with possibly clinically significant (PCS) laboratory values by functional group (haematology, differentials, coagulation, electrolytes, enzymes, and substrates). Acronyms Used: Prothrombin time-International normalized ratio (PT-INR), Alanine aminotransferase/Glutamic pyruvic transaminase (ALT/GPT) Serum glutamic pyruvic transaminase (SGPT), Aspartate aminotransferase/Glutamic-oxaloacetic transaminase (AST/GOT) Serum glutamic-oxaloacetic transaminase (SGOT) (NCT01271725)
Timeframe: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days

,,
InterventionParticipants (Number)
Haematology - Haemoglobin (low)Haematology - White blood cell count (low)Haematology - Platelets (low)Differentials, automatic - Neutrophils (low)Coagulation - PT-INR (high)Electrolytes - Potassium (low)Electrolytes - Potassium (high)Electrolytes - Magnesium (low)Enzymes - AST/GOT SGOT (high)Enzymes - ALT/GPT SGPT (high)Enzymes - Alkaline phosphatase (high)Substrates - Creatinine (high)Substrates - Bilirubin, total (high)
Afatinib and Paclitaxel Combination Therapy1713112030124210
Afatinib and Vinorelbine Combination Therapy59010000003101
Afatinib Monotherapy9521132086602

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Duration of Objective Response According to RECIST v1.1

Duration of objective response, defined as the time from first objective response to the time of progression or death. (regardless of confirmation). As Per RECIST v1.1 for target lesions and assessed by Magnetic resonance imaging (MRI): Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least 30% decrease in the sum of the longest diameter of target lesions; progression, at least 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. (NCT01271725)
Timeframe: From the first objective response to the time of progression or death, up to 1562 days

InterventionDays (Median)
Afatinib Monotherapy168.5
Afatinib and Paclitaxel or Vinorelbine Combination Therapy125.0

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Change From Baseline to End of Treatment in Diastolic Blood Pressure (DBP)

Change from baseline to end of treatment in diastolic blood pressure (DBP). (NCT01271725)
Timeframe: Baseline and End of treatment period, up to 1562 days

InterventionMillimeter of mercury (mmHg) (Mean)
Afatinib Monotherapy-1.8
Afatinib and Vinorelbine Combination Therapy1.9
Afatinib and Paclitaxel Combination Therapy-1.6

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Change From Baseline to End of Treatment in Systolic Blood Pressure (SBP)

Change from baseline to end of treatment in systolic blood pressure (SBP). (NCT01271725)
Timeframe: Baseline and End of treatment period, up to 1562 days

InterventionMillimeter of mercury (mmHg) (Mean)
Afatinib Monotherapy-1.2
Afatinib and Vinorelbine Combination Therapy-1.0
Afatinib and Paclitaxel Combination Therapy-3.7

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Intracranial Objective Response Rate- Modified RECIST Criteria

"response will be evaluated via gadolinium-enhanced brain MRI using modified RECIST criteria.~Complete Response (CR) - Disappearance of all target and nontarget lesions~Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.~Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size." (NCT01305941)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Complete ResponsePartial ResponseStable DiseaseProgressive Disease
Everolimus +Vinorelbine + Trastuzumab01178

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Extracranial Response

"Extracranial response was measured using RECIST 1.1 criteria and defined as the number of subjects achieving CR or PR.~Complete Response (CR) - Disappearance of all target and nontarget lesions Partial Response (PR) - at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum longest diameter AND an absolute decrease of at least 5mm in at least one target lesion.~Stable Disease (SD) - neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum of the longest diameter since the treatment started.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size." (NCT01305941)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Everolimus +Vinorelbine + Trastuzumab5

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Overall Survival

Overall survival (OS) after administration of everolimus in combination with trastuzumab and vinorelbine (NCT01305941)
Timeframe: 3 years

Interventionyears (Median)
Everolimus +Vinorelbine + Trastuzumab1.01

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Extracranial Time to Progression

"To evaluate the extracranial time to progression as determined by RECIST 1.1 criteria after administration of everolimus in combination with trastuzumab and vinorelbine.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size." (NCT01305941)
Timeframe: 3 years

Interventionmonths (Median)
Everolimus +Vinorelbine + Trastuzumab4.01

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Functional Assessment Cancer Therapy- Breast (FACT-B) From Baseline to 9 Weeks of Treatment to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life

The FACT-B is a 10-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with breast cancer. Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-B subscale range from 0 to 40 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments. (NCT01305941)
Timeframe: 9 weeks

Interventionunits on a scale (Median)
Everolimus +Vinorelbine + Trastuzumab1.0

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Intracranial Response Rate- MacDonald Criteria

"Intracranial tumor lesions were evaluated via gadolinium-enhanced brain MRI using the MacDonald criteria. Measurable disease is defined as at least 1 measurable brain lesion accurately measured in at least 2 dimensions (longest diameter) as ≥5.0 mm. Tumor size is the product of the 2 longest bi-dimensional lines.~Complete Response (CR)- Disappearance of all tumor on consecutive CT or MRI scans at least 1 month apart, off steroids for treatment of neurological symptoms, and neurologically stable or improved.~Partial Response (PR)- ≥50% reduction in size of tumor on consecutive CT or MRI scans at least 1 month part, steroids stable or reduced, and neurologically stable or improved.~Progressive Disease (PD)- ≥25% increase in size of tumor or any new tumor on CT or MRI scans, or neurologically worse, and steroids stable or increased due to neurologic symptoms.~Stable Disease (SD)- all other situations Overall Response Rate (ORR) is the sum of partial responses (PRs) and CRs." (NCT01305941)
Timeframe: 3 years

InterventionParticipants (Count of Participants)
Everolimus +Vinorelbine + Trastuzumab1

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Functional Assessment of Cancer Therapy- Brain (FACT-Br) Change From Baseline to Assess Impact of Everolimus in Combination With Trastuzumab and Vinorelbine on Quality of Life

The FACT-Br is a 23-question self-report questionnaire subscale administered with the Functional Assessment of Cancer Therapy- General (FACT-G) which contains concerns relevant to patients with brain tumors . Each question has a value 0-4. For some questions a higher indicates better outcome and others are the opposite. The former are summed as is, the latter are reversed in value before adding, such that each domain ranges from 0 to 4 times the number of questions in the domain, with 0 indicating worst and the highest possible value indicating best outcome. Total scores on the FACT-Br subscale range from 0 to 92 with lower scores indicating declining quality of life. The change from baseline is the difference in scores between the baseline and 9 week assessments. (NCT01305941)
Timeframe: 9 weeks

Interventionunits on a scale (Median)
Everolimus +Vinorelbine + Trastuzumab-1.0

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Toxicity

"Grade 3 or higher toxicities of interest are reported. Toxicity was assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.~The NCI CTCAE is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE." (NCT01305941)
Timeframe: 24 weeks

InterventionParticipants (Count of Participants)
Alkaline phosphatase increasedAnemiaAnorexiaAsparate Aminotransferase IncreasedDiarrheaFebrile NeutropeniaHyperkalemiaLymphocyte Count DecreasedMucositis OralNeutrophil Count DecreasedPneumonitisSepsisWhite Blood Cell Decreased
Everolimus +Vinorelbine + Trastuzumab151212135131311

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Time to Intracranial Progression.

"Time to intracranial progression after administration of everolimus in combination with trastuzumab and vinorelbine as defined via modified RECIST criteria.~Progressive Disease (PD) - at least a 20% increase in the sum LD of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started AND an absolute increase in size of at least 5 mm in at least one target lesion OR the appearance of one or more new lesions of at least 6 mm in size." (NCT01305941)
Timeframe: 3 years

Interventionmonths (Median)
Everolimus +Vinorelbine + Trastuzumab3.93

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Part B: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Tumour response was assessed separately for Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). (NCT01325428)
Timeframe: This endpoint was recorded from first administration of trial medication in Part B until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.

InterventionPercentage of participants (Number)
Part B: Afatinib Once Daily (OD)+V (Vinorelbine).20

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Part B: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1 ).

Objective response was defined on a patient level as a best response of CR or PR. (NCT01325428)
Timeframe: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of PD, death or start of new anti-cancer therapy up to 929 days.

InterventionPercentage of participants (Number)
Part B: Afatinib Once Daily (OD)+V (Vinorelbine).30

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Part A: Unconfirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).

Objective response was defined on a patient level as a best response of CR or PR. (NCT01325428)
Timeframe: This endpoint was recorded from first administration of trial medication until the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.

InterventionPercentage of participants (Number)
Part A: Afatinib Once Daily (OD).42

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Part A: Progression Free Survival.

PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study A. (NCT01325428)
Timeframe: From first drug administration until end of Part A, up to 713 days.

InterventionDays (Median)
Part A: Afatinib Once Daily (OD).110.5

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Part A: Duration of Unconfirmed Objective Response.

Objective Response (OR) was defined on a patient level as a best response of Complete Response (CR) or Partial Response (PR). Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for Progression Free Survival (PFS)). (NCT01325428)
Timeframe: From first drug administration until end of Part A, up to 929 days.

InterventionDays (Median)
Part A: Afatinib Once Daily (OD).NA

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Progression Free Survival Over the Whole Sudy.

PD was evaluated according to the RECIST version 1.1. Number of days from the start of monotherapy to the date of second PD. (NCT01325428)
Timeframe: From first drug administration until end of study, up to 700 days.

InterventionDays (Median)
Afatinib Once Daily (OD). Afatinib+V (Vinorelbine).253.0

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Part B: Duration of Unconfirmed Objective Response.

Objective response was defined on a patient level as a best response of CR or PR. Duration of objective response was measured from the time of first unconfirmed objective response to the time of progression or death (or date of censoring for PFS). (NCT01325428)
Timeframe: From first drug administration until end of Part B, up to 929 days.

InterventionDays (Median)
Part B: Afatinib Once Daily (OD)+V (Vinorelbine).57

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Part B: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).

Objective response was defined on a patient level as a best response of CR or PR. (NCT01325428)
Timeframe: This endpoint was recorded from first administration of trial medication in Part B and until the earliest of disease progression, death or start of new anti-cancer therapy up to 929 days.

InterventionPercentage of participants (Number)
Part B: Afatinib Once Daily (OD)+V (Vinorelbine).10

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Part A: Clinical Benefit (CB) Assessed by Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at Least 6 Months Using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

Tumour response was assessed separately for Part A and Part B according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The primary endpoint of this study was confirmed clinical benefit, as assessed by Stable Disease (SD) for at least 6 months (defined as >182 days), Partial Response (PR), or Complete Response (CR) according to RECIST version 1.1 (only confirmed responses were considered). (NCT01325428)
Timeframe: This endpoint was assessed between the from first administration of trial medication in Part A and the earliest of PD, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.

InterventionPercentage of participants (Number)
Part A: Afatinib Once Daily (OD).35

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Part A: Confirmed Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST 1.1).

Objective response was defined on a patient level as a best response of CR or PR. (NCT01325428)
Timeframe: This endpoint was recorded from first administration of trial medication until the earliest of disease progression, death or start of next treatment (either Part B combination therapy or new anti-cancer therapy) up to 929 days.

InterventionPercentage of participants (Number)
Part A: Afatinib Once Daily (OD).31

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Part B: Progression Free Survival.

PD was evaluated according to the RECIST version 1.1. For patients with a known date of progression (or death), PFS was the earlier of date of progression or death - date of first administration + 1. The date of progression and date of first administration referred to the respective part of the study B. (NCT01325428)
Timeframe: From first drug administration until end of Part B, up to 230 days.

InterventionDays (Median)
Part B: Afatinib Once Daily (OD)+V (Vinorelbine).106.0

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Patient Benefit Rate at 12 Weeks

Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1 (NCT01441596)
Timeframe: 12 weeks from randomisation

Interventionpercentage of participants (Number)
Afatinib Mono30.0
Afatinib+Vino34.2
Investigator's Choice41.9

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Overall Survival

Overall Survival is defined as time from randomisation to the date of death from any cause. (NCT01441596)
Timeframe: From first drug administration until 28 days after end of treatment, up to 805 days

Interventionweeks (Median)
Afatinib Mono57.7
Afatinib+Vino37.3
Investigator's Choice52.1

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Progression-Free Survival

"Progression-Free Survival is defined as the time from the date of randomisation to the date of disease progression or death whichever came first.~Disease progression was defined as either disease progression in CNS lesions (including worsening in NSS and use of corticosteroid) or disease progression in extra-CNS lesions according to RECIST 1.1." (NCT01441596)
Timeframe: From first drug administration until 28 days after end of treatment, up to 805 days

Interventionweeks (Median)
Afatinib Mono11.9
Afatinib+Vino12.3
Investigator's Choice18.4

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Pathologic Response Rate

The percentage of patients with a major pathologic response (NCT01443078)
Timeframe: 2 years

Interventionpercentage of patients (Number)
All Patients17

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PERCIST Partial Metabolic Response

"The primary endpoint was partial metabolic response after 2 cycles of switch therapy as assessed by PERCIST (SUVmax decrease ≥30% using the pre-switch scan as new baseline)." (NCT01443078)
Timeframe: 2 years

Interventionparticipants (Number)
All Patients6

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Objective Response Rate (ORR)

The ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST criteria. The ORR was estimated by study arm based on the tumor response evaluation as determined by the investigator, according to RECIST 1.1. Participants with unknown response were treated as non-responders. The statistical difference in ORR between treatment arms was evaluated using the Cochran-Mantel-Haenszel (CMH) chi-square test with histology, TPC option, and geographic region as strata, tested at an alpha level of 0.05 (2-sided). The 95 percent confidence interval (CI) was calculated using Clopper Pearson method. (NCT01454934)
Timeframe: Randomization (Day 1) to CR or PR

Interventionpercentage of participants (Number)
Arm A: Eribulin Mesylate12.2
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed15.2

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Overall Survival (OS)

The OS was defined as the time in months from the date of randomization to the date of death, regardless of cause. In the absence of confirmation of death, the participants were censored either at the date that participant was last known to be alive or the date of study cut-off, whichever was earlier. The two treatment arms were compared using the log-rank test, stratified by histology, TPC option, and geographic region; and the treatment difference between eribulin mesylate and TPC was tested at a significance level of 0.05 (2-sided). Kaplan-Meier (K-M) survival probabilities for each arm were plotted over time. The treatment effect was estimated by fitting a Cox Proportional Hazards model to the OS times including treatment arm as a factor and histology, TPC option and geographic region as strata. (NCT01454934)
Timeframe: Randomization (Day 1) until date of death from any cause, or 37 months

Interventionmonths (Median)
Arm A: Eribulin Mesylate9.5
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed9.5

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Progression Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST)

PFS was defined as the time from the date of randomization to the date of first documentation of disease progression, or date of death, whichever occurred first. The difference in PFS (based on the tumor response evaluation as determined by the investigator) between eribulin mesylate and TPC was evaluated using the log rank test, stratified by histology, TPC option, and geographic region, tested at an alpha level of 0.05 (2-sided). PFS censoring rules will be defined in the SAP and follow Federal Department of Agriculture (FDA) guidance. (NCT01454934)
Timeframe: Randomization (Day 1) until date of disease progression or death (whichever occurred first), or 37 months

Interventionmonths (Median)
Arm A: Eribulin Mesylate3.0
Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed2.8

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Progression-free Survival

IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months. (NCT01497860)
Timeframe: Assessed throughout the study from the first dose of the study drug to the date of progressive disease, death, or 60m.

Interventionpercentage (Number)
Vinorelbine23.1

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Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Tumor response was assessed by investigator according to RECIST v1.1. BOR was defined as percentage of participants with a confirmed complete response (CR) or partial response (PR). All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total or pathological nodes (with short axis [SA] of at least (>/=) 15 millimeter [mm]) were identified as target lesions (TLs) and measured and recorded at baseline. A sum of diameters (longest for non-nodal lesions, SA for nodal lesions) for all TLs was calculated and reported as baseline sum of diameters (SD). All other lesions (or sites of disease) were identified as non-TLs. CR: disappearance of all TLs and SA reduction to less than (<) 10 mm for nodal TLs/ non-TLs. PR: >/=30 percent (%) decrease in SD of TLs, taking as reference baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. The 95% confidence interval (CI) was computed using Clopper-Pearson approach. (NCT01565083)
Timeframe: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion74.2
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion63.7

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Percentage of Participants Who Died From Any Cause

Percentage of participants who died due to any cause was reported. (NCT01565083)
Timeframe: Baseline until death (up to approximately 3.5 years)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion21.7
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion21.5

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Overall Survival (OS)

OS was defined as the time from first intake of any study medication to the date of death, regardless of the cause of death. Participants who were known to be alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study treatment, and participants with no post-baseline information were censored at the date of first study treatment plus 1 day. Participants who died due to any cause were considered as having an event. The median OS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. (NCT01565083)
Timeframe: Baseline until death (up to approximately 3.5 years)

Interventionmonths (Median)
Pertuzumab + Trastuzumab + Vinorelbine: Separate InfusionNA
Pertuzumab + Trastuzumab + Vinorelbine: Single InfusionNA

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Duration of Response (DOR) as Assessed by Investigator According to RECIST v 1.1

DOR, in participants with a BOR of CR or PR, was defined as the period from the date of initial PR or CR until the date of PD or death from any cause. Participants with no documented PD or death after CR or PR were censored at the last date at which they were known to have had the CR or PR, respectively (regardless of the response at intermediate assessments). CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation. (NCT01565083)
Timeframe: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)

Interventionmonths (Median)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion13.3
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion11.8

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Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score

FACT-B questionnaire is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures ranges from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL. (NCT01565083)
Timeframe: Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)

,
Interventionunits on a scale (Mean)
Baseline (n = 100, 100)Change at Cycle 3 (n = 82, 90)Change at Cycle 6 (n=70, 79)Change at Cycle 9 (n=65, 60)Change at Cycle 12 (n=52, 51)Change at Cycle 15 (n=43, 44)Change at Cycle 18 (n=32, 32)Change at Cycle 21 (n=29, 24)Change at Cycle 24 (n= 26, 23)Change at Cycle 27 (n=20, 22)Change at Cycle 30 (n=18, 24)Change at Cycle 33 (n=14, 17)Change at Cycle 36 (n=15, 13)Change at Cycle 39 (n=6, 6)Change at Cycle 42 (n=4, 0)Change at Cycle 45 (n=1, 0)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion76.7-1.96-0.971.440.402.724.583.221.194.913.965.751.26-3.68-0.171.00
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion78.5-2.570.47-0.420.510.090.51-0.23-1.030.55-0.261.762.747.33NANA

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Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1

PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 was reported. (NCT01565083)
Timeframe: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion67.9
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion61.7

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Percentage of Participants With Disease Progression as Assessed by Investigator According to RECIST v1.1 or Death From Any Cause

PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Percentage of participants with radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause was reported. (NCT01565083)
Timeframe: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)

Interventionpercentage of participants (Number)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion69.8
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion67.3

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Progression-free Survival (PFS) as Assessed by Investigator According to RECIST v 1.1

PFS was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PFS events were censored at the time of the last evaluable tumor assessment. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 or died due to any cause were considered as having an event. The median PFS was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. (NCT01565083)
Timeframe: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)

Interventionmonths (Median)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion14.3
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion11.5

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Time to Progression (TTP) as Assessed by Investigator According to RECIST v 1.1

TTP was defined as the time from first intake of any study medication until the first radio-graphically documented PD as assessed by investigator according to RECIST v1.1. Participants who did not have a radio-graphically documented PD and had died due to reason other than PD were censored on the last available tumor assessment prior to the death date. Participants with no baseline or no tumor assessment after the baseline visit were censored on the date of first study treatment. PD was defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. Participants who had radio-graphically documented PD as assessed by investigator according to RECIST v1.1 were considered as having an event. The median TTP was estimated using Kaplan-Meier method. The 95% CI was computed using log-log transformation. (NCT01565083)
Timeframe: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)

Interventionmonths (Median)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion14.9
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion12.8

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Time to Response as Assessed by Investigator According to RECIST v 1.1

For participants with a BOR of CR or PR, time to response = (Date of first confirmed CR/PR - Date of first study treatment) + 1. For participants without a CR or PR, time to response = (Date of adequate last tumor assessment - Date of first study treatment) + 1. For participant with no tumor assessment (or if all assessments were progressive disease [PD]) the censoring day was set to date of first study treatment +1. CR: the disappearance of all TLs and SA reduction to <10 mm for nodal TLs/ non-TLs. PR: >/=30% decrease in SD of TLs, taking as reference the baseline SD. Confirmation of response at 2 consecutive tumor assessments >/=4 weeks apart was required. PD: >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. The 95% CI was computed using log-log transformation. (NCT01565083)
Timeframe: Baseline, every 3 cycles up to 36 months, and every 6 cycles thereafter if progression free after 36 months, 28 days after end of treatment, every 3 months thereafter (maximum up to approximately 3.5 years)

Interventionmonths (Median)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion2.1
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion2.2

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Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire Visual Analogue Scale (VAS) Score

EQ-5D VAS: participant rated questionnaire to assess health-related quality of life (QoL) in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. (NCT01565083)
Timeframe: Baseline, thereafter every 3 cycles from Cycle 3 to Cycle 45 (each cycle = 21 days)

,
Interventionunits on a scale (Mean)
Baseline (n = 102, 102)Change at Cycle 3 (n = 83, 90)Change at Cycle 6 (n=68, 82)Change at Cycle 9 (n=67, 68)Change at Cycle 12 (n=53, 59)Change at Cycle 15 (n=43, 43)Change at Cycle 18 (n=32, 28)Change at Cycle 21 (n=30, 27)Change at Cycle 24 (n=25, 26)Change at Cycle 27 (n=21, 24)Change at Cycle 30 (n=18, 19)Change at Cycle 33 (n=15, 15)Change at Cycle 36 (n=14, 7)Change at Cycle 39 (n=6, 1)Change at Cycle 42 (n=2, 0)Change at Cycle 45 (n=1, 0)
Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion69.70.91.02.2-1.46.35.73.23.15.95.42.94.815.8-5.05.0
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion68.61.74.36.66.88.16.51.32.81.19.513.47.350.0NANA

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Survival at 12 Months

Evaluate the proportion of patients who are alive at 12 months following randomization (NCT02117024)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
Viagenpumatucel-L Plus Metronomic Cyclophosphamide8
Chemotherapy Alone11

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Time to Progression (TTP)

Evaluate immune-related TTP (irTTP) and also TTP (Time to Progression) by RECIST (NCT02117024)
Timeframe: Up to 3 years

,
InterventionDays (Median)
immune-related TTP (irTTP)Time to Progression (TTP)
Chemotherapy Alone71.073.5
Viagenpumatucel-L Plus Metronomic Cyclophosphamide67.067.5

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Survival at 6 Months

Evaluate the proportion of patients who are alive at 6 months following randomization (NCT02117024)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Viagenpumatucel-L Plus Metronomic Cyclophosphamide21
Chemotherapy Alone17

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Frequency of Adverse Events: Number of Participants With Treatment-Emergent Adverse Events (TEAE)

Evaluate the safety of the combination of viagenpumatucel-L and low-dose cyclophosphamide by frequency of Treatment-Emergent Adverse Events (NCT02117024)
Timeframe: Up to 3 years

,
InterventionParticipants (Count of Participants)
At least one TEAEAt least one severe TEAEAt least one treatment-related TEAEAt least one SAEFatal TEAEAt least one TEAE Leading to Tx DiscontinuationAt least one TEAE Leading to a Dose Reduction
Chemotherapy Alone2011158022
Viagenpumatucel-L Plus Metronomic Cyclophosphamide41253217770

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Progression-Free Survival (PFS)

Evaluate immune-related PFS (irPFS) and PFS by RECIST (Response Evaluation Criteria for Solid Tumors) (NCT02117024)
Timeframe: Up to 3 years

,
InterventionDays (Median)
immune-related PFS (irPFS)Progression Free Survival (PFS)
Chemotherapy Alone190.0190.0
Viagenpumatucel-L Plus Metronomic Cyclophosphamide76.070.0

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Overall Survival (OS)

"Overall survival (OS) calculated as the duration of survival from the date of randomization to the date of death from any cause, or was censored on the date the patient was last known to be alive.~Survival time was calculated from the randomization date up to the date of death,or censored on the date that the patient was last known to be alive (last available visit date) utilizing Kaplan-Meier Estimate of Overall Survival Ending Events" (NCT02117024)
Timeframe: Up to 3 years

InterventionDays (Median)
Viagenpumatucel-L Plus Metronomic Cyclophosphamide176
Chemotherapy Alone372

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Percentage of Participants Alive at 12 Months (OS12)

The OS12 was defined as the percentage of participants who were alive at 12 months after randomisation per Kaplan-Meier estimate of OS at 12 months. (NCT02352948)
Timeframe: From randomization (Day 1) up to 12 months

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab49.3
Sub-study A: SoC31.3
Sub-study B: Durvalumab+Tremelimumab49.5
Sub-study B: SoC38.8
Sub-study B: Durvalumab43.6
Sub-study B: Tremelimumab41.2

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PFS, Contribution of the Components Analysis of Sub-study B

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study B: Durvalumab+Tremelimumab3.5
Sub-study B: Durvalumab3.1
Sub-study B: Tremelimumab2.1

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Time From Randomisation to Second Progression (PFS2) of Sub-study B

The PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to that used for the PFS endpoint or death and determined by local standard clinical practice and have included any of the following: objective radiological, symptomatic progression, or death. PFS2 was reported for sub-study B only. (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until first progression. Disease then assessed per local practice until 2nd progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study B: Durvalumab+Tremelimumab9.1
Sub-study B: SoC6.7
Sub-study B: Durvalumab8.0
Sub-study B: Tremelimumab5.7

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Percentage of Participants Alive and Progression Free at 6 Months (APF6)

The APF6 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 6 months after randomization per Kaplan-Meier estimate of PFS at 6 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 6 months

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab35.5
Sub-study A: SoC24.1
Sub-study B: Durvalumab+Tremelimumab31.5
Sub-study B: SoC27.6
Sub-study B: Durvalumab27.2
Sub-study B: Tremelimumab14.5

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Progression-Free Survival (PFS)

The PFS was defined as the time from the date of randomization until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy prior to progression. The PFS was determined by Investigator assessments according to response evaluation criteria in solid tumours (RECIST) version 1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study A: Durvalumab3.8
Sub-study A: SoC2.2
Sub-study B: Durvalumab+Tremelimumab3.5
Sub-study B: SoC3.5

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Duration of Response (DoR)

The DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression. The DoR was determined by Investigator assessments according to RECIST v1.1. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionmonths (Median)
Sub-study A: Durvalumab9.5
Sub-study A: SoC4.8
Sub-study B: Durvalumab+Tremelimumab12.2
Sub-study B: SoC10.8
Sub-study B: Durvalumab10.0
Sub-study B: Tremelimumab4.7

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Objective Response Rate (ORR)

The ORR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) among ITT participants who had measurable disease at baseline. CR was defined as disappearance of all target lesions (any pathological lymph nodes selected as target lesions must have a reduction in short axis to <10 mm) and PR was defined as at least a 30% decrease in the sum of diameters of target lesions (taking as reference the baseline sum of diameters as long as criteria for PD are not met). The ORR was measured using Investigator assessments according to RECIST v1.1. (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~12 weeks thereafter until confirmed disease progression. Assessed up to a maximum of approximately 3 years.

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab35.5
Sub-study A: SoC12.5
Sub-study B: Durvalumab+Tremelimumab14.9
Sub-study B: SoC6.8
Sub-study B: Durvalumab15.4
Sub-study B: Tremelimumab6.7

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OS, Contribution of the Components Analysis of Sub-study B

The OS was defined as the time from the date of randomization until death due to any cause. (NCT02352948)
Timeframe: From randomization (Day 1) until death due to any cause, approximately 36 months

Interventionmonths (Median)
Sub-study B: Durvalumab+Tremelimumab11.5
Sub-study B: Durvalumab10.0
Sub-study B: Tremelimumab6.9

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Overall Survival (OS)

The OS was defined as the time from the date of randomization until death due to any cause. (NCT02352948)
Timeframe: From randomization (Day 1) until death due to any cause, approximately 36 months

Interventionmonths (Median)
Sub-study A: Durvalumab11.7
Sub-study A: SoC6.8
Sub-study B: Durvalumab+Tremelimumab11.5
Sub-study B: SoC8.7

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Percentage of Participants Alive and Progression Free at 12 Months (APF12)

The APF12 was defined as the percentage of participants who were alive and progression free per RECIST v1.1 at 12 months after randomization per Kaplan-Meier estimate of PFS at 12 months. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 millimeter (mm) or progression of non-target lesions or the appearance of a new lesion (NCT02352948)
Timeframe: Tumour scans performed at baseline then every ~8 weeks up to 12 months.

Interventionpercentage of participants (Number)
Sub-study A: Durvalumab19.4
Sub-study A: SoC9.9
Sub-study B: Durvalumab+Tremelimumab20.6
Sub-study B: SoC8.0
Sub-study B: Durvalumab15.0
Sub-study B: Tremelimumab7.3

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Overall Survival in Participants With Programmed Cell Death Ligand 1 (PD-L1) With Combined Positive Score (CPS) ≥10

Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab12.7
Chemotherapy11.6

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Overall Survival in Participants With PD-L1 CPS ≥1

Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab10.7
Chemotherapy10.2

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Overall Survival in All Participants

Overall survival (OS) was defined as the time from randomization to death due to any cause. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab9.9
Chemotherapy10.8

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Overall Response Rate Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants With PD-L1 CPS ≥10

Overall Response Rate (ORR), based on a Blinded Independent Central Review (BICR) assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab17.7
Chemotherapy9.2

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Duration of Response Per RECIST 1.1 in All Participants Who Had a Confirmed Response

For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab12.2
ChemotherapyNA

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Overall Response Rate Per RECIST 1.1 in All Participants

Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab9.6
Chemotherapy10.6

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Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥1 Who Had a Confirmed Response

For participants with PD-L1 CPS ≥1 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab12.2
ChemotherapyNA

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Duration of Response Per RECIST 1.1 in Participants With PD-L1 CPS ≥10 Who Had a Confirmed Response

For participants with PD-L1 CPS ≥10 who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, Duration of Response (DOR) was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on BICR. (NCT02555657)
Timeframe: Up to approximately 36 months (from time of first documented evidence of CR or PR through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
PembrolizumabNA
Chemotherapy7.1

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Number of Participants Who Discontinued Study Treatment Due to an Adverse Event

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT02555657)
Timeframe: Up to approximately 60 months

InterventionParticipants (Count of Participants)
Pembrolizumab14
Chemotherapy16

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Number of Participants Who Experienced One or More Adverse Events

An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT02555657)
Timeframe: Up to approximately 60 months

InterventionParticipants (Count of Participants)
Pembrolizumab285
Chemotherapy281

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Disease Control Rate Per RECIST 1.1 in All Participants

Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab12.2
Chemotherapy18.7

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Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab14.3
Chemotherapy15.8

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Disease Control Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥10

Disease Control Rate (DCR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) or Stable Disease for at least 24 weeks (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease [PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered PD.]) (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab19.8
Chemotherapy17.3

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Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥10

Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab2.1
Chemotherapy3.4

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Progression-Free Survival Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab2.1
Chemotherapy3.1

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Progression-Free Survival Per RECIST 1.1 in All Participants

Progression-Free Survival (PFS), based on BICR assessment per RECIST 1.1, was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionMonths (Median)
Pembrolizumab2.1
Chemotherapy3.3

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Overall Response Rate Per RECIST 1.1 in Participants With PD-L1 CPS ≥1

Overall Response Rate (ORR), based on BICR assessment per RECIST 1.1, was defined as the percentage of participants who had a confirmed Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions). (NCT02555657)
Timeframe: Up to approximately 36 months (through Final Analysis database cutoff date of 11-April-2019)

InterventionPercentage of participants (Number)
Pembrolizumab12.3
Chemotherapy9.4

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Overall Survival (OS) in ITT Population

Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

Interventionmonths (Median)
Sacituzumab Govitecan11.8
Treatment of Physician's Choice (TPC)6.9

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Overall Survival (OS) in BM-ve Population

Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From the randomization to death from any cause (maximum follow-up duration: 30.8 months)

Interventionmonths (Median)
Sacituzumab Govitecan12.1
Treatment of Physician's Choice (TPC)6.7

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Percentage of Participants Experiencing Any Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation of Study Drug

"Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:~Fatal~Life-threatening~Disabling/incapacitating~Results in hospitalization or prolongs a hospital stay~A congenital abnormality~Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above" (NCT02574455)
Timeframe: First dose date up to last follow-up (maximum up to 30.8 months)

,
Interventionpercentage of participants (Number)
Any TEAEsSAEsTEAEs Leading to Discontinuation of Study Drug
Sacituzumab Govitecan99.626.74.7
Treatment of Physician's Choice (TPC)97.828.65.4

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Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population

ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

,
Interventionpercentage of participants (Number)
ORR by IRC AssessmentORR by Investigator Assessment
Sacituzumab Govitecan34.933.2
Treatment of Physician's Choice (TPC)4.76.4

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Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population

DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. (NCT02574455)
Timeframe: From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

,
Interventionmonths (Median)
IRC AssessmentInvestigator Assessment
Sacituzumab Govitecan6.36.9
Treatment of Physician's Choice (TPC)3.63.0

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Clinical Benefit Rate (CBR) by IRC and Investigator Assessment in BM-ve Population

CBR was defined as the percentage of participants with best response as either CR, PR, or stable disease (SD) with a duration of ≥6 months. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started; and Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD: ≥20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. (NCT02574455)
Timeframe: From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

,
Interventionpercentage of participants (Number)
IRC AssessmentInvestigator Assessment
Sacituzumab Govitecan44.745.5
Treatment of Physician's Choice (TPC)8.610.3

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Change From Baseline in European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (EORTC QLQ-C30) Score

The EORTC QLQ-C30 is a questionnaire to assess quality of life (QoL), it is composed of 30 questions (items) resulting in 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, pain), and 6 single items (dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Higher score for the functioning scales and global health status indicate a better quality of life; a positive change from baseline indicates improvement. Lower scores on the symptom and single-item scales indicate a better quality of life; a negative change from baseline indicates improvement. (NCT02574455)
Timeframe: Baseline; End of Treatment (EOT) (up to 29.6 months)

,
Interventionscore on a scale (Mean)
Global Health Status/QoL: BaselineGlobal Health Status/QoL: Change From Baseline at EOTPhysical Functioning: BaselinePhysical Functioning: Change From Baseline at EOTRole Functioning: BaselineRole Functioning: Change From Baseline at EOTEmotional Functioning: BaselineEmotional Functioning: Change From Baseline at EOTCognitive Functioning: BaselineCognitive Functioning: Change From Baseline at EOTSocial Functioning: BaselineSocial Functioning: Change From Baseline at EOTFatigue: BaselineFatigue: Change From Baseline at EOTNausea and Vomiting: BaselineNausea and Vomiting: Change From Baseline at EOTPain: BaselinePain: Change From Baseline at EOTDyspnoea: BaselineDyspnoea: Change From Baseline at EOTInsomnia: BaselineInsomnia: Change From Baseline at EOTAppetite Loss: BaselineAppetite Loss: Change From Baseline at EOTConstipation: BaselineConstipation: Change From Baseline at EOTDiarrhoea: BaselineDiarrhoea: Change From Baseline at EOTFinancial Difficulties: BaselineFinancial Difficulties: Change From Baseline at EOT
Sacituzumab Govitecan61.9-5.873.2-4.668.1-8.471.9-3.881.7-7.569.1-5.939.45.18.35.237.92.825.40.733.24.420.83.117.73.37.211.427.60.4
Treatment of Physician's Choice (TPC)56.4-9.471.2-13.565.1-18.868.9-3.579.5-6.169.6-10.342.114.010.37.342.56.825.05.935.6-4.325.810.019.07.06.53.622.41.1

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Time to Progression (TTP) by IRC Assessment in BM-ve Population

Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. (NCT02574455)
Timeframe: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan5.8
Treatment of Physician's Choice (TPC)2.1

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Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population

PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to [≥] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan5.6
Treatment of Physician's Choice (TPC)1.7

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Time to Progression (TTP) by Investigator Assessment in BM-ve Population

Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. (NCT02574455)
Timeframe: From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan5.7
Treatment of Physician's Choice (TPC)1.8

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Time to Objective Response by the Investigator Assessment in BM-ve Population

Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Mean)
Sacituzumab Govitecan2.14
Treatment of Physician's Choice (TPC)2.72

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Progression-Free Survival (PFS) by IRC Assessment in the ITT Population

PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. (NCT02574455)
Timeframe: From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Median)
Sacituzumab Govitecan4.8
Treatment of Physician's Choice (TPC)1.7

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Percentage of Participants Experiencing the Worst Laboratory Abnormalities Grade 3 or 4 Post-Baseline

Blood samples were collected for hematology, serum chemistry and the laboratory abnormalities were assessed. The most severe graded abnormality observed post-baseline for each graded test was counted for each participant. Safety as assessed by grading of laboratory values and AEs according to the National Cancer Institutes' Common Terminology Criteria for Adverse Events (NCI CTCAE) covering grades 0-5 (0=Normal, 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death). The percentage of participants with worst postbaseline grades 3 or 4 are reported. (NCT02574455)
Timeframe: First dose date up to last follow-up (maximum up to 30.8 months)

,
Interventionpercentage of participants (Number)
AnemiaLymphocyte Count DecreasedNeutrophil Count DecreasedPlatelet Count DecreasedWhite Blood Cell DecreasedAlanine Aminotransferase IncreasedAlkaline Phosphatase IncreasedAspartate Aminotransferase IncreasedBlood Bilirubin IncreasedCreatinine IncreasedHypercalcemiaHyperglycemiaHyperkalemiaHypermagnesemiaHypernatremiaHypoalbumenemiaHypocalcemiaHypoglycemiaHypokalemiaHypomagnesemiaHyponatremiaHypophosphatemia
Sacituzumab Govitecan8.933.348.81.241.11.23.13.51.90.403.10.80.400.81.60.44.30.83.98.1
Treatment of Physician's Choice (TPC)5.425.035.32.725.42.23.62.22.700.43.100.401.31.300.903.63.6

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Time to Objective Response by the IRC Assessment in BM-ve Population

Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. (NCT02574455)
Timeframe: From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months)

Interventionmonths (Mean)
Sacituzumab Govitecan2.67
Treatment of Physician's Choice (TPC)1.86

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Percentage of Participants With Confirmed Improvement of Pain

"Improvement rate of pain was defined as the number of patients with confirmed improvement of pain (based on the pain at its worst item of MDASI-MPM), divided by the number of patients evaluable for improvement of pain." (NCT02610140)
Timeframe: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.

Interventionpercentage of participants (Number)
Anetumab Ravtansine40.4
Vinorelbine32.7

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Percentage of Participant With Treatment-emergent Adverse Events (TEAEs)

TEAEs were defined as all AEs starting or worsening within the treatment period. (NCT02610140)
Timeframe: Up to approx. 55 months (data cut-off: 02-Jul-2019) - Time from randomization until 30 days after last treatment (general AEs), or further until death from any cause (selected AEs).

,
InterventionPercentage of participants (Number)
Any TEAEAny study drug-related TEAETreatment-emergent serious adverse events (TESAEs)
Anetumab Ravtansine99.488.334.4
Vinorelbine98.690.334.7

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Objective Response Rate (ORR)

A patient is a responder if the patient has a confirmed best tumor response on-study of CR (Complete response) or PR (Partial response), as determined by the central radiological reviewer per mRECIST criteria. ORR in each treatment arm was defined as the number of responders divided by the number of randomized patients. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria. (NCT02610140)
Timeframe: up to approx. 30 months (data cut-off: 31-May-2017) - Time from randomization until death from any cause.

Interventionpercentage of participants (Number)
Anetumab Ravtansine8.4
Vinorelbine6.1

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Number of Deaths

TEAE(s) associated with a fatal outcome (CTCAE Grade 5) at the time of the data cut-off 06-Apr-2018. (NCT02610140)
Timeframe: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.

InterventionNumber of Deaths (Number)
Anetumab Ravtansine10
Vinorelbine1

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Duration of Response (DOR)

DOR was defined in responders as the time from central documentation of tumor response date of first response in the confirmation sequence) to the earlier of disease progression as determined by the central radiological reviewer, or death without centrally documented progression. A responder was a patient who had a confirmed best tumor response on-study of CR or PR, as determined by the central radiological reviewer per mRECIST criteria. (NCT02610140)
Timeframe: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.

Interventionmonths (Median)
Anetumab Ravtansine7.4
Vinorelbine6.7

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Durable Response Rate (DRR)

A durable responder was a responder (i.e. confirmed best tumor response on study of CR or PR) with duration of response of 180 days or more. (NCT02610140)
Timeframe: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.

Interventionpercentage of participants (Number)
Anetumab Ravtansine7.2
Vinorelbine4.9

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Disease Control Rate (DCR)

A patient has disease control if the patient has a best tumor response on-study of CR, PR, or SD (Stable disease). DCR was defined as a percentage of patients achieving CR, PR, or SD per mRECIST criteria, as determined by the central radiological reviewer. DCR was calculated in each treatment arm as the number of patients with disease control (a best tumor response on-study of CR, PR, or SD) divided by the number of randomized patients. (NCT02610140)
Timeframe: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause.

Interventionpercentage of participants (Number)
Anetumab Ravtansine73.5
Vinorelbine68.3

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Overall Survival (OS), [95% CI]

Overall survival (OS) was defined as time from randomization until death from any cause. (NCT02610140)
Timeframe: Up to approx. 40 months (data cut-off: 06-Apr-2018) - Time from randomization until death from any cause; one-sided log-rank test stratified by time to progression (TTP) on first line treatment.

Interventionmonths (Median)
Anetumab Ravtansine9.5
Vinorelbine11.6

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Overall Survival (OS) - Addendum

Overall survival (OS) was defined as time from randomization until death from any cause; Only descriptive analyses of OS were repeated in with the data as of the 02 JUL 2019. (NCT02610140)
Timeframe: Up to approx. 55 month (data cut-off: 02-JUL-2019) - Time from randomization until death from any cause

Interventionmonths (Mean)
Anetumab Ravtansine9.5
Vinorelbine11.6

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Percentage of Participants With Confirmed Improvement of Symptoms Characteristic of Mesothelioma

Improvement rate of symptoms characteristic of mesothelioma was defined as the number of patients with confirmed improvement of symptoms characteristic of mesothelioma (based on the MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma, MDASI-MPM), divided by the number of patients evaluable for improvement of symptoms characteristic of mesothelioma. (NCT02610140)
Timeframe: up to approx. 30 months (data cut-off: 31-May-2017)

Interventionpercentage of participants (Number)
Anetumab Ravtansine22.5
Vinorelbine17.9

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Progression-free Survival (PFS), [95% CI]

Progression-free survival (PFS), defined as time from randomization until disease progression according to mRECIST (Modified Response Evaluation Criteria in Solid Tumors) for Malignant pleural mesothelioma (MPM) per blinded central radiology review, or death. Only descriptive analysis of OS was repeated in the follow-up period. (NCT02610140)
Timeframe: From randomization till approximately 117 PFS events observed, up to approx. 30 months (data cut-off: 31-May-2017)

Interventionmonths (Median)
Anetumab Ravtansine4.3
Vinorelbine4.5

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Time to Worsening of Pain

Time to worsening of pain (TTWP) was defined in patients evaluable for assessing worsening of pain, as time from randomization until the first worsening of pain. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of pain were censored at the date of their last MDASI-MPM assessment with a non-missing pain score. (NCT02610140)
Timeframe: up to approx. 30 months (data cut-off: 31-May-2017)

Interventiondays (Median)
Anetumab Ravtansine210
VinorelbineNA

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Time to Worsening of Symptoms Characteristic of Mesothelioma

Time to worsening of symptoms characteristic of mesothelioma (TTWS) was defined in patients evaluable for assessing worsening of symptoms, as the time from randomization until the first worsening of symptoms characteristic of mesothelioma. Patients who died, were lost to follow-up, or ended (MD Anderson Symptom Inventory-Malignant Pleural Mesothelioma) MDASI-MPM assessments without confirmed worsening of symptoms were censored at the date of their last MDASI-MPM assessment with a non-missing (Composite Symptom Score) CSS. (NCT02610140)
Timeframe: up to approx. 30 months (data cut-off: 31-May-2017)

Interventiondays (Median)
Anetumab RavtansineNA
VinorelbineNA

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Phase 1 - Rate of Participants Experiencing Adverse Events

Rate of participants experiencing adverse events including dose-limiting toxicities (DLTs) and serious adverse events (SAEs). (NCT02658084)
Timeframe: 18 months

Interventionparticipants (Number)
Dose-limiting toxicities (DLTs)Adverse events (AEs)
Phase 1: T-DM1 + Vinorelbine22

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Progression-Free Survival in Brain Metastasis (PFS-BM)

Progression-Free Survival in Brain Metastasis (PFS-BM) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) per Response Assessment in Neuro-Oncology-Brain Metastases (RANO-BM) in brain metastases or death from any cause. The PD will also be determined by the investigator's assessments. Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1023.9
Treatment of Physician's Choice (TPC)3.3

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Clinical Benefit Rate (CBR)

Clinical Benefit Rate will be defined as the proportion of patients having a Complete Response (CR), Partial Response (PR), or Stable Disease (SD) for at least 4 months (≥ 120 days). CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT02915744)
Timeframe: For at least 4 months, with an expected average of 1 year

,
Interventionparticipants (Number)
# of Patients who achieved Complete Response# of Patients who achieved Partial Response# of Patients who have Stable Disease >= 120 days# of Patients who achieved Clinical Benefit Rate (CBR)
NKTR-102061723
Treatment of Physician's Choice (TPC)06511

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Duration of Response (DoR)

Duration of response (DoR) outside the CNS will be defined as the time from first documented CR or PR until the earliest evidence of disease progression per RECIST v1.1 or death from any cause. CR is defined as disappearance of all target lesions for at least 4 weeks with no new lesions, not use of corticosteroids, and patient was stable or improved clinically. PR is defined as at least a 30% decrease in the sum of longest diameters sustained for at least 4 weeks, no new lesions; stable to decreased corticosteroid dose; stable or improved clinically. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study). Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1027.4
Treatment of Physician's Choice (TPC)3.5

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Magnitude of Clinical Benefit Assessed by ESMO-MCBS Derived From Overall Survival

The magnitude of clinical benefit of NKTR-102 is assessed by the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (v1.0). The scale is graded 5, 4, 3, 2, 1, where grades 5 and 4 represent a high level of proven clinical benefit, and grade 1 represents no clinical benefit. To determine the magnitude of clinical benefit when the median OS with the standard of treatment is ≤ 1 year, the score is derived from the Hazard Ratio (HR) of Overall Survival, overall survival gain, and QoL improvement between two treatment arms. Values reported in the data table are Overall Survival values. (NCT02915744)
Timeframe: Through study completion, within 3 years from study start

Interventionmonths (Median)
NKTR-1027.8
Treatment of Physician's Choice (TPC)7.5

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Number of Participants With Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3

The number of participants with adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.3 (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

InterventionParticipants (Count of Participants)
NKTR-10290
Treatment of Physician's Choice (TPC)76

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Overall Survival (OS) of Patients

To compare Overall Survival (OS) of patients who receive 145 mg/m2 NKTR-102 given once every 21 days (q21d) with OS of patients who receive Treatment of Physician's Choice (TPC). Overall survival is defined as the time from the date of randomization to the date of death from any cause. Patients will be followed until their date of death or until final database closure. Patients who are lost-to-follow-up or are alive at the time of analysis will be censored at the time they were last known to be alive or at the date of event cut-off for OS analysis. (NCT02915744)
Timeframe: Within 3 years from study start

Interventionmonths (Median)
NKTR-1027.8
Treatment of Physician's Choice (TPC)7.5

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Progression-Free Survival (Outside the Central Nervous System)

Progression-Free Survival (PFS) is defined as the time from the date of randomization to the earliest evidence of documented Progressive Disease (PD) or of death from any cause. The date of global deterioration or symptomatic deterioration will not be used as the date of PD. The assessment of PFS outside the CNS will utilize RECIST criteria v1.1. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1022.8
Treatment of Physician's Choice (TPC)1.9

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Progression-Free Survival (Overall)

Progression-free survival (CNS and peripheral) is defined as the time from the date of randomization to the earliest evidence of documented PD in either the CNS or peripheral (using RANO-BM) or death from any cause. The PD will be determined by both the investigator's and the central imaging facility assessments. The same statistical methods that were used for PFS and PFS-BM will be used for PFS (Overall). Progressive Disease (PD) is defined as at least a 20% increase in the sum of longest diameters of CNS target lesions, taking as reference the smallest sum on study. This included the baseline sum if that was the smallest on study. In addition to the relative increase of 20%, at least 1 lesion had to increase by an absolute value of 5 mm or more to be considered progression. (NCT02915744)
Timeframe: Through study completion, an expected average of 1 year

Interventionmonths (Median)
NKTR-1022.1
Treatment of Physician's Choice (TPC)1.9

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Time to Treatment Failure.

Time from from randomisation to discontinuation of treatment for any reason, including progression of disease, treatment toxicity, refusal and death, by Kaplan Meier method. Censoring will occur at the last follow-up date. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm2.8
Standard Chemotherapy Arm2.3

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Objective Response Rate by Independent Radiological Review

Defined as the best overall response (complete or partial response) across all assessment time-points from randomisation to end of trial treatment, determined by RECIST 1.1 criteria. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionpercentage of participants (Number)
Pembrolizumab Arm21.9
Standard Chemotherapy Arm5.6

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Progression Free Survival (PFS) Assessed by Investigator

Investigator assessed PFS, from the date of randomisation until documented progression or death, if progression is not documented. Censoring occurs at the last tumor assessment. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm3.5
Standard Chemotherapy Arm3.7

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Progression Free Survival (PFS) as Assessed by Independent Radiological Review

To investigate whether treatment with pembrolizumab improves PFS, compared to standard, institutional choice chemotherapy, assessed according to RECIST 1.1 criteria based on independent radiological review; using Kaplan-Meier method and compared between the two treatment arms by a stratified log rank test. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

Interventionmonths (Median)
Pembrolizumab Arm2.5
Standard Chemotherapy Arm3.4

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Overall Survival.

Defined as time from the date of randomisation until death from any cause. Censoring will occur at the last follow-up date. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the OS analysis (Sep 2017 - Aug 2019; approximately 2 years).

Interventionmonths (Median)
Pembrolizumab Arm10.7
Standard Chemotherapy Arm12.4

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Percentage of Patients Experienced AEs/SAEs

The safety and tolerability of pembrolizumab treatment will be assessed through analysis of the worst grade of toxicity/adverse events according to CTCAE v4.0 criteria observed over the whole treatment period. Adverse events are collected from study treatment initiation to 30 days after treatment is ceased for any reason. Serious adverse events and events of clinical interest are collected within 90 days after last dose of trial treatment. (NCT02991482)
Timeframe: Time from randomization of the first patient until database cutoff date for the primary PFS analysis (Sep 2017 - Feb 2019; approximately 1.5 years).

,
InterventionParticipants (Count of Participants)
Experienced any adverse eventExperienced treatment related adverse eventExperienced treatment related adverse event of grade 3-5Experienced treatment related adverse event leading to deathExperienced treatment related adverse event leading to treatment discontinuation
Pembrolizumab Arm70501415
Standard Chemotherapy Arm65521815

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Time to Death or Distant Metastases (TTDM)

TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment. (NCT02998528)
Timeframe: From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)

InterventionMonths (Median)
Arm B: Platinum Doublet Chemo26.71
Arm C: Nivo 360 mg + Platinum Doublet ChemoNA

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Major Pathologic Response (MPR) Rate

Major pathologic response (MPR) rate is defined as number of randomized participants with NCT02998528)
Timeframe: From randomization up to a median of 30 months after randomization.

InterventionParticipants (Count of Participants)
Arm B: Platinum Doublet Chemo16
Arm C: Nivo 360 mg + Platinum Doublet Chemo66

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Event-Free Survival (EFS)

Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). (NCT02998528)
Timeframe: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)

InterventionMonths (Median)
Arm B: Platinum Doublet Chemo20.80
Arm C: Nivo 360 mg + Platinum Doublet Chemo31.57

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Pathologic Complete Response (pCR) Rate

Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). (NCT02998528)
Timeframe: From randomization up to a median of 30 months after randomization.

InterventionParticipants (Count of Participants)
Arm B: Platinum Doublet Chemo4
Arm C: Nivo 360 mg + Platinum Doublet Chemo43

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Duration of Response (DOR), as Determined by the Investigator Using RECIST v1.1

DOR is defined as the time from the first tumor assessment that supports the participants' objective response (CR or PR, whichever is first reported) to documented disease progression as determined by the investigator according to RECIST v1.1 or death from any cause, whichever occurs first, among patients who have a best overall response as CR or PR. (NCT03191786)
Timeframe: Time from the first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab14.0
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)7.8

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Overall Survival (OS)

Overall survival is defined as the time between the date of randomization and the date of death due to any cause. (NCT03191786)
Timeframe: From randomization up to death from any cause (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab10.3
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)9.2

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Overall Survival in Participants With PD-L1 Positive Status

Overall survival will be assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay. (NCT03191786)
Timeframe: From randomization up to death from any cause (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab9.4
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)10.3

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Percentage of Participants With At Lease One Adverse Event

Percentage of participants with at least one adverse event. (NCT03191786)
Timeframe: From randomization up to approximately 55 months

InterventionPercentage of participants (Number)
Atezolizumab91.7
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)97.3

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Percentage of Participants With Objective Response Rate, as Determined by the Investigator Using Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 (v1.1)

Objective response rate (ORR) is defined as a Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR), as determined by the investigator with use of RECIST v1.1. A minimum interval of 6 weeks (42 days) will be considered for Stable Disease (SD) to be assigned as best overall response, i.e. in the case the single response is SD, PR or CR, this single response must have been assessed no less than 6 weeks (at least 42 days) after start date of study treatment. (NCT03191786)
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionPercentage of participants (Number)
Atezolizumab16.9
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)7.9

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Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1

PFS is defined as the time from randomization to the first documented disease progression as determined by the investigator with the use of RECIST v1.1 or death from any cause, whichever occurs first. (NCT03191786)
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab4.2
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)4.0

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Progression-Free Survival (PFS), as Determined by the Investigator Using RECIST v1.1 in Participants With PD-L1 Positive Status

Investigator-assessed PFS according to RECIST v1.1 assessed in participants whose tumors express PD-L1 protein as measured by PD-L1 SP263 IHC assay. (NCT03191786)
Timeframe: From randomization to the first occurence of disease progression or death from any cause, whichever occurs first (up to approximately 55 months)

InterventionMonths (Median)
Atezolizumab4.2
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)3.0

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Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score

The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
Dyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Safety Follow-Up VisitCoughing, BaselineCoughing, Week 6Coughing, Week 12Coughing, Week 18Coughing, Week 24Coughing, Week 30Coughing, Week 36Coughing, Week 42Coughing, Week 48Coughing, Week 57Coughing, Week 66Coughing, Week 75Coughing, Week 84Coughing, Week 93Coughing, Week 102Coughing, Safety Follow-Up VisitHaemoptysis, BaselineHaemoptysis, Week 6Haemoptysis, Week 12Haemoptysis, Week 18Haemoptysis, Week 24Haemoptysis, Week 30Haemoptysis, Week 36Haemoptysis, Week 42Haemoptysis, Week 48Haemoptysis, Week 57Haemoptysis, Week 66Haemoptysis, Week 75Haemoptysis, Week 84Haemoptysis, Week 93Haemoptysis, Week 102Haemoptysis, Safety Follow-Up VisitSore Mouth, BaselineSore Mouth, Week 6Sore Mouth, Week 12Sore Mouth, Week 18Sore Mouth, Week 24Sore Mouth, Week 30Sore Mouth, Week 36Sore Mouth, Week 42Sore Mouth, Week 48Sore Mouth, Week 57Sore Mouth, Week 66Sore Mouth, Week 75Sore Mouth, Week 84Sore Mouth, Week 93Sore Mouth, Week 102Sore Mouth, Safety Follow-Up VisitDysphagia, BaselineDysphagia, Week 6Dysphagia, Week 12Dysphagia, Week 18Dysphagia, Week 24Dysphagia, Week 30Dysphagia, Week 36Dysphagia, Week 42Dysphagia, Week 48Dysphagia, Week 57Dysphagia, Week 66Dysphagia, Week 75Dysphagia, Week 84Dysphagia, Week 93Dysphagia, Week 102Dysphagia, Safety Follow-Up VisitPeripheral Neuropathy, BaselinePeripheral Neuropathy, Week 6Peripheral Neuropathy, Week 12Peripheral Neuropathy, Week 18Peripheral Neuropathy, Week 24Peripheral Neuropathy, Week 30Peripheral Neuropathy, Week 36Peripheral Neuropathy, Week 42Peripheral Neuropathy, Week 48Peripheral Neuropathy, Week 57Peripheral Neuropathy, Week 66Peripheral Neuropathy, Week 75Peripheral Neuropathy, Week 84Peripheral Neuropathy, Week 93Peripheral Neuropathy, Week 102Peripheral Neuropathy, Safety Follow-Up VisitAlopecia, BaselineAlopecia, Week 6Alopecia, Week 12Alopecia, Week 18Alopecia, Week 24Alopecia, Week 30Alopecia, Week 36Alopecia, Week 42Alopecia, Week 48Alopecia, Week 57Alopecia, Week 66Alopecia, Week 75Alopecia, Week 84Alopecia, Week 93Alopecia, Week 102Alopecia, Safety Follow-Up VisitPain in Chest, BaselinePain in Chest, Week 6Pain in Chest, Week 12Pain in Chest, Week 18Pain in Chest, Week 24Pain in Chest, Week 30Pain in Chest, Week 36Pain in Chest, Week 42Pain in Chest, Week 48Pain in Chest, Week 57Pain in Chest, Week 66Pain in Chest, Week 75Pain in Chest, Week 84Pain in Chest, Week 93Pain in Chest, Safety Follow-Up VisitPain in Arm or Shoulder, BaselinePain in Arm or Shoulder, Week 6Pain in Arm or Shoulder, Week 12Pain in Arm or Shoulder, Week 18Pain in Arm or Shoulder, Week 24Pain in Arm or Shoulder, Week 30Pain in Arm or Shoulder, Week 36Pain in Arm or Shoulder, Week 42Pain in Arm or Shoulder, Week 48Pain in Arm or Shoulder, Week 57Pain in Arm or Shoulder, Week 66Pain in Arm or Shoulder, Week 75Pain in Arm or Shoulder, Week 84Pain in Arm or Shoulder, Week 93Pain in Arm or Shoulder, Safety Follow-Up VisitPain in other parts, BaselinePain in other parts, Week 6Pain in other parts, Week 12Pain in other parts, Week 18Pain in other parts, Week 24Pain in other parts, Week 30Pain in other parts, Week 36Pain in other parts, Week 42Pain in other parts, Week 48Pain in other parts, Week 57Pain in other parts, Week 66Pain in other parts, Week 75Pain in other parts, Week 84Pain in other parts, Week 93Pain in other parts, Safety Follow-Up Visit
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)36.670.92-2.870.902.681.525.56-6.841.854.170.00-2.783.705.560.006.4846.26-5.46-9.38-3.423.330.000.00-2.380.004.17-13.33-8.3311.1116.670.00-17.957.76-4.64-3.17-1.71-1.11-2.90-6.25-2.38-5.56-8.330.000.000.000.000.00-2.565.020.000.002.562.300.00-2.084.76-2.780.006.6716.6711.110.000.000.008.682.90-1.04-0.851.112.906.254.760.004.170.0016.670.000.000.000.0014.841.452.085.137.78-1.4512.509.528.3320.8313.338.330.000.000.00-2.784.836.097.9412.8214.2910.1410.427.1413.8929.176.678.3311.1116.6733.3312.8219.91-4.09-5.29-5.26-2.30-9.092.38-2.563.03-4.76-16.67-22.22-16.670.0012.8219.08-0.58-4.23-2.630.004.55-2.22-5.13-6.06-9.52-33.33-33.33-16.670.007.6927.551.18-0.5411.11-4.76-7.582.22-12.82-15.15-9.52-16.670.000.000.000.00

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Change From Baseline in EORTC QLQ Supplementary Lung Cancer Module 13 (EORTC QLQ-LC13) Score

The EORTC QLQ-LC13 module incorporates one multiple item scale to assess dyspnea and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. The EORTC QLQ-LC13 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however, a high score for a symptom scale or item represents a high level of symptomatology or problems. A≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
Dyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Week 111Dyspnoea, Week 120Dyspnoea, Week 129Dyspnoea, Week 138Dyspnoea, Week 147Dyspnoea, Week 156Dyspnoea, Week 165Dyspnoea, Week 174Dyspnoea, Week 183Dyspnoea, Week 192Dyspnoea, Week 201Dyspnoea, Week 210Dyspnoea, Safety Follow-Up VisitCoughing, BaselineCoughing, Week 6Coughing, Week 12Coughing, Week 18Coughing, Week 24Coughing, Week 30Coughing, Week 36Coughing, Week 42Coughing, Week 48Coughing, Week 57Coughing, Week 66Coughing, Week 75Coughing, Week 84Coughing, Week 93Coughing, Week 102Coughing, Week 111Coughing, Week 120Coughing, Week 129Coughing, Week 138Coughing, Week 147Coughing, Week 156Coughing, Week 165Coughing, Week 174Coughing, Week 183Coughing, Week 192Coughing, Week 201Coughing, Week 210Coughing, Safety Follow-Up VisitHaemoptysis, BaselineHaemoptysis, Week 6Haemoptysis, Week 12Haemoptysis, Week 18Haemoptysis, Week 24Haemoptysis, Week 30Haemoptysis, Week 36Haemoptysis, Week 42Haemoptysis, Week 48Haemoptysis, Week 57Haemoptysis, Week 66Haemoptysis, Week 75Haemoptysis, Week 84Haemoptysis, Week 93Haemoptysis, Week 102Haemoptysis, Week 111Haemoptysis, Week 120Haemoptysis, Week 129Haemoptysis, Week 138Haemoptysis, Week 147Haemoptysis, Week 156Haemoptysis, Week 165Haemoptysis, Week 174Haemoptysis, Week 183Haemoptysis, Week 192Haemoptysis, Week 201Haemoptysis, Week 210Haemoptysis, Safety Follow-Up VisitSore Mouth, BaselineSore Mouth, Week 6Sore Mouth, Week 12Sore Mouth, Week 18Sore Mouth, Week 24Sore Mouth, Week 30Sore Mouth, Week 36Sore Mouth, Week 42Sore Mouth, Week 48Sore Mouth, Week 57Sore Mouth, Week 66Sore Mouth, Week 75Sore Mouth, Week 84Sore Mouth, Week 93Sore Mouth, Week 102Sore Mouth, Week 111Sore Mouth, Week 120Sore Mouth, Week 129Sore Mouth, Week 138Sore Mouth, Week 147Sore Mouth, Week 156Sore Mouth, Week 165Sore Mouth, Week 174Sore Mouth, Week 183Sore Mouth, Week 192Sore Mouth, Week 201Sore Mouth, Week 210Sore Mouth, Safety Follow-Up VisitDysphagia, BaselineDysphagia, Week 6Dysphagia, Week 12Dysphagia, Week 18Dysphagia, Week 24Dysphagia, Week 30Dysphagia, Week 36Dysphagia, Week 42Dysphagia, Week 48Dysphagia, Week 57Dysphagia, Week 66Dysphagia, Week 75Dysphagia, Week 84Dysphagia, Week 93Dysphagia, Week 102Dysphagia, Week 111Dysphagia, Week 120Dysphagia, Week 129Dysphagia, Week 138Dysphagia, Week 147Dysphagia, Week 156Dysphagia, Week 165Dysphagia, Week 174Dysphagia, Week 183Dysphagia, Week 192Dysphagia, Week 201Dysphagia, Week 210Dysphagia, Safety Follow-Up VisitPeripheral Neuropathy, BaselinePeripheral Neuropathy, Week 6Peripheral Neuropathy, Week 12Peripheral Neuropathy, Week 18Peripheral Neuropathy, Week 24Peripheral Neuropathy, Week 30Peripheral Neuropathy, Week 36Peripheral Neuropathy, Week 42Peripheral Neuropathy, Week 48Peripheral Neuropathy, Week 57Peripheral Neuropathy, Week 66Peripheral Neuropathy, Week 75Peripheral Neuropathy, Week 84Peripheral Neuropathy, Week 93Peripheral Neuropathy, Week 102Peripheral Neuropathy, Week 111Peripheral Neuropathy, Week 120Peripheral Neuropathy, Week 129Peripheral Neuropathy, Week 138Peripheral Neuropathy, Week 147Peripheral Neuropathy, Week 156Peripheral Neuropathy, Week 165Peripheral Neuropathy, Week 174Peripheral Neuropathy, Week 183Peripheral Neuropathy, Week 192Peripheral Neuropathy, Week 201Peripheral Neuropathy, Week 210Peripheral Neuropathy, Safety Follow-Up VisitAlopecia, BaselineAlopecia, Week 6Alopecia, Week 12Alopecia, Week 18Alopecia, Week 24Alopecia, Week 30Alopecia, Week 36Alopecia, Week 42Alopecia, Week 48Alopecia, Week 57Alopecia, Week 66Alopecia, Week 75Alopecia, Week 84Alopecia, Week 93Alopecia, Week 102Alopecia, Week 111Alopecia, Week 120Alopecia, Week 129Alopecia, Week 138Alopecia, Week 147Alopecia, Week 156Alopecia, Week 165Alopecia, Week 174Alopecia, Week 183Alopecia, Week 192Alopecia, Week 201Alopecia, Week 210Alopecia, Safety Follow-Up VisitPain in Chest, BaselinePain in Chest, Week 6Pain in Chest, Week 12Pain in Chest, Week 18Pain in Chest, Week 24Pain in Chest, Week 30Pain in Chest, Week 36Pain in Chest, Week 42Pain in Chest, Week 48Pain in Chest, Week 57Pain in Chest, Week 66Pain in Chest, Week 75Pain in Chest, Week 84Pain in Chest, Week 93Pain in Chest, Week 102Pain in Chest, Week 111Pain in Chest, Week 120Pain in Chest, Week 129Pain in Chest, Week 138Pain in Chest, Week 147Pain in Chest, Week 156Pain in Chest, Week 165Pain in Chest, Week 174Pain in Chest, Week 183Pain in Chest, Week 192Pain in Chest, Week 201Pain in Chest, Week 210Pain in Chest, Safety Follow-Up VisitPain in Arm or Shoulder, BaselinePain in Arm or Shoulder, Week 6Pain in Arm or Shoulder, Week 12Pain in Arm or Shoulder, Week 18Pain in Arm or Shoulder, Week 24Pain in Arm or Shoulder, Week 30Pain in Arm or Shoulder, Week 36Pain in Arm or Shoulder, Week 42Pain in Arm or Shoulder, Week 48Pain in Arm or Shoulder, Week 57Pain in Arm or Shoulder, Week 66Pain in Arm or Shoulder, Week 75Pain in Arm or Shoulder, Week 84Pain in Arm or Shoulder, Week 93Pain in Arm or Shoulder, Week 102Pain in Arm or Shoulder, Week 111Pain in Arm or Shoulder, Week 120Pain in Arm or Shoulder, Week 129Pain in Arm or Shoulder, Week 138Pain in Arm or Shoulder, Week 147Pain in Arm or Shoulder, Week 156Pain in Arm or Shoulder, Week 165Pain in Arm or Shoulder, Week 174Pain in Arm or Shoulder, Week 183Pain in Arm or Shoulder, Week 192Pain in Arm or Shoulder, Week 201Pain in Arm or Shoulder, Week 210Pain in Arm or Shoulder, Safety Follow-Up VisitPain in other parts, BaselinePain in other parts, Week 6Pain in other parts, Week 12Pain in other parts, Week 18Pain in other parts, Week 24Pain in other parts, Week 30Pain in other parts, Week 36Pain in other parts, Week 42Pain in other parts, Week 48Pain in other parts, Week 57Pain in other parts, Week 66Pain in other parts, Week 75Pain in other parts, Week 84Pain in other parts, Week 93Pain in other parts, Week 102Pain in other parts, Week 111Pain in other parts, Week 120Pain in other parts, Week 129Pain in other parts, Week 138Pain in other parts, Week 147Pain in other parts, Week 156Pain in other parts, Week 165Pain in other parts, Week 174Pain in other parts, Week 183Pain in other parts, Week 192Pain in other parts, Week 201Pain in other parts, Week 210Pain in other parts, Safety Follow-Up Visit
Atezolizumab34.301.13-0.23-4.78-5.05-5.34-3.90-11.11-4.84-7.89-6.58-4.55-8.50-2.34-2.96-2.56-4.273.700.00-0.851.59-1.851.595.565.560.000.0012.1241.36-1.80-7.61-9.64-11.01-9.24-7.10-10.06-15.91-14.29-11.46-9.33-19.30-21.67-14.58-11.90-11.90-14.29-16.67-21.43-23.81-16.67-19.050.00-16.670.000.003.035.860.75-1.80-1.64-2.52-3.97-1.67-1.26-3.79-2.78-2.15-1.33-3.51-1.67-2.08-2.38-2.38-2.38-2.38-2.380.000.000.000.000.000.000.003.034.171.64-0.22-0.82-1.90-3.57-2.730.00-5.30-5.56-4.17-5.33-1.75-1.672.080.002.38-4.762.380.000.004.170.000.000.000.000.0027.2711.15-1.20-0.44-2.19-4.72-3.57-6.11-7.55-5.30-3.70-6.45-4.00-8.770.000.00-4.762.38-2.384.76-4.760.00-8.330.000.000.0016.670.0012.1211.263.291.991.103.774.827.788.186.827.416.255.338.776.676.252.382.382.380.002.38-4.760.00-4.76-8.3316.670.000.0021.217.91-1.06-2.01-1.93-1.27-1.205.563.853.107.626.675.561.755.004.172.384.762.387.142.380.000.000.000.008.3316.670.000.0020.29-2.45-4.03-9.37-7.62-7.23-11.67-11.54-17.83-18.10-15.05-13.89-22.81-23.33-20.83-26.19-26.19-21.43-26.19-19.05-23.81-25.00-23.81-16.67-16.67-33.33-66.670.0019.16-0.450.67-1.65-3.21-0.40-4.44-1.89-1.527.411.08-1.393.516.678.332.384.762.382.382.389.524.170.0025.000.000.000.0012.1225.32-1.85-0.91-1.74-3.53-2.88-5.08-2.67-4.65-1.963.458.33-1.75-3.33-4.17-5.130.00-7.14-7.140.00-14.29-16.67-9.528.33-8.33-33.33-66.679.09

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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score

EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
GHS/HRQoL Scale Score, BaselineGHS/HRQoL Scale Score, Week 6GHS/HRQoL Scale Score, Week 12GHS/HRQoL Scale Score, Week 18GHS/HRQoL Scale Score, Week 24GHS/HRQoL Scale Score, Week 30GHS/HRQoL Scale Score, Week 36GHS/HRQoL Scale Score, Week 42GHS/HRQoL Scale Score, Week 48GHS/HRQoL Scale Score, Week 57GHS/HRQoL Scale Score, Week 66GHS/HRQoL Scale Score, Week 75GHS/HRQoL Scale Score, Week 84GHS/HRQoL Scale Score, Week 93GHS/HRQoL Scale Score, Week 102GHS/HRQoL Scale Score, Safety Follow-Up VisitPhysical Functioning, BaselinePhysical Functioning, Week 6Physical Functioning, Week 12Physical Functioning, Week 18Physical Functioning, Week 24Physical Functioning, Week 30Physical Functioning, Week 36Physical Functioning, Week 42Physical Functioning, Week 48Physical Functioning, Week 57Physical Functioning, Week 66Physical Functioning, Week 75Physical Functioning, Week 84Physical Functioning, Week 93Physical Functioning, Week 102Physical Functioning, Safety Follow-Up VisitRole Functioning, BaselineRole Functioning, Week 6Role Functioning, Week 12Role Functioning, Week 18Role Functioning, Week 24Role Functioning, Week 30Role Functioning, Week 36Role Functioning, Week 42Role Functioning, Week 48Role Functioning, Week 57Role Functioning, Week 66Role Functioning, Week 75Role Functioning, Week 84Role Functioning, Week 93Role Functioning, Week 102Role Functioning, Safety Follow-Up VisitEmotional Functioning, BaselineEmotional Functioning, Week 6Emotional Functioning, Week 12Emotional Functioning, Week 18Emotional Functioning, Week 24Emotional Functioning, Week 30Emotional Functioning, Week 36Emotional Functioning, Week 42Emotional Functioning, Week 48Emotional Functioning, Week 57Emotional Functioning, Week 66Emotional Functioning, Week 75Emotional Functioning, Week 84Emotional Functioning, Week 93Emotional Functioning, Week 102Emotional Functioning, Safety Follow-Up VisitCognitive Functioning, BaselineCognitive Functioning, Week 6Cognitive Functioning, Week 12Cognitive Functioning, Week 18Cognitive Functioning, Week 24Cognitive Functioning, Week 30Cognitive Functioning, Week 36Cognitive Functioning, Week 42Cognitive Functioning, Week 48Cognitive Functioning, Week 57Cognitive Functioning, Week 66Cognitive Functioning, Week 75Cognitive Functioning, Week 84Cognitive Functioning, Week 93Cognitive Functioning, Week 102Cognitive Functioning, Safety Follow-Up VisitSocial Functioning, BaselineSocial Functioning, Week 6Social Functioning, Week 12Social Functioning, Week 18Social Functioning, Week 24Social Functioning, Week 30Social Functioning, Week 36Social Functioning, Week 42Social Functioning, Week 48Social Functioning, Week 57Social Functioning, Week 66Social Functioning, Week 75Social Functioning, Week 84Social Functioning, Week 93Social Functioning, Week 102Social Functioning, Safety Follow-Up VisitFatigue, BaselineFatigue, Week 6Fatigue, Week 12Fatigue, Week 18Fatigue, Week 24Fatigue, Week 30Fatigue, Week 36Fatigue, Week 42Fatigue, Week 48Fatigue, Week 57Fatigue, Week 66Fatigue, Week 75Fatigue, Week 84Fatigue, Week 93Fatigue, Week 102Fatigue, Safety Follow-Up VisitNausea and Vomiting, BaselineNausea and Vomiting, Week 6Nausea and Vomiting, Week 12Nausea and Vomiting, Week 18Nausea and Vomiting, Week 24Nausea and Vomiting, Week 30Nausea and Vomiting, Week 36Nausea and Vomiting, Week 42Nausea and Vomiting, Week 48Nausea and Vomiting, Week 57Nausea and Vomiting, Week 66Nausea and Vomiting, Week 75Nausea and Vomiting, Week 84Nausea and Vomiting, Week 93Nausea and Vomiting, Week 102Nausea and Vomiting, Safety Follow-Up VisitPain, BaselinePain, Week 6Pain, Week 12Pain, Week 18Pain, Week 24Pain, Week 30Pain, Week 36Pain, Week 42Pain, Week 48Pain, Week 57Pain, Week 66Pain, Week 75Pain, Week 84Pain, Week 93Pain, Week 102Pain, Safety Follow-Up VisitDyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Safety Follow-Up VisitInsomnia, BaselineInsomnia, Week 6Insomnia, Week 12Insomnia, Week 18Insomnia, Week 24Insomnia, Week 30Insomnia, Week 36Insomnia, Week 42Insomnia, Week 48Insomnia, Week 57Insomnia, Week 66Insomnia, Week 75Insomnia, Week 84Insomnia, Week 93Insomnia, Week 102Insomnia, Safety Follow-Up VisitAppetite Loss, BaselineAppetite Loss, Week 6Appetite Loss, Week 12Appetite Loss, Week 18Appetite Loss, Week 24Appetite Loss, Week 30Appetite Loss, Week 36Appetite Loss, Week 42Appetite Loss, Week 48Appetite Loss, Week 57Appetite Loss, Week 66Appetite Loss, Week 75Appetite Loss, Week 84Appetite Loss, Week 93Appetite Loss, Week 102Appetite Loss, Safety Follow-Up VisitConstipation, BaselineConstipation, Week 6Constipation, Week 12Constipation, Week 18Constipation, Week 24Constipation, Week 30Constipation, Week 36Constipation, Week 42Constipation, Week 48Constipation, Week 57Constipation, Week 66Constipation, Week 75Constipation, Week 84Constipation, Week 93Constipation, Week 102Constipation, Safety Follow-Up VisitDiarrhoea, BaselineDiarrhoea, Week 6Diarrhoea, Week 12Diarrhoea, Week 18Diarrhoea, Week 24Diarrhoea, Week 30Diarrhoea, Week 36Diarrhoea, Week 42Diarrhoea, Week 48Diarrhoea, Week 57Diarrhoea, Week 66Diarrhoea, Week 75Diarrhoea, Week 84Diarrhoea, Week 93Diarrhoea, Week 102Diarrhoea, Safety Follow-Up VisitFinancial Difficulties, BaselineFinancial Difficulties, Week 6Financial Difficulties, Week 12Financial Difficulties, Week 18Financial Difficulties, Week 24Financial Difficulties, Week 30Financial Difficulties, Week 36Financial Difficulties, Week 42Financial Difficulties, Week 48Financial Difficulties, Week 57Financial Difficulties, Week 66Financial Difficulties, Week 75Financial Difficulties, Week 84Financial Difficulties, Week 93Financial Difficulties, Week 102Financial Difficulties, Safety Follow-Up Visit
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)55.250.291.85-0.42-1.722.65-0.521.194.868.335.002.08-2.78-12.50-25.003.8561.97-1.071.46-1.58-5.50-1.23-4.900.952.22-3.332.67-1.67-8.89-26.67-40.00-6.6761.72-3.51-1.591.71-5.00-7.25-14.58-4.76-2.78-4.17-6.678.33-11.11-25.00-33.33-1.2873.380.464.210.284.072.17-5.38-7.14-3.473.136.6712.500.00-4.17-16.67-5.7782.65-5.94-2.60-7.92-10.00-8.70-11.46-7.14-11.11-2.08-3.33-4.175.560.000.005.1374.43-4.49-4.17-14.17-11.11-5.80-14.58-7.14-5.562.083.334.1722.228.3316.67-12.8242.622.08-1.562.222.96-3.384.863.171.851.39-6.67-8.3322.2222.2233.331.717.991.013.653.333.333.623.133.570.002.08-3.33-4.170.00-8.330.000.0032.99-1.01-5.733.753.89-9.423.13-4.76-11.11-6.25-20.000.00-11.11-16.67-33.33-7.6939.31-0.58-4.69-3.33-4.44-8.700.00-7.69-3.03-12.50-20.00-16.670.00-16.670.00-2.7831.05-1.16-3.65-2.50-5.56-15.94-18.75-9.522.784.17-6.67-16.67-22.220.000.00-5.1331.050.007.2913.3310.007.256.252.385.568.3313.330.0022.2250.0066.67-7.6921.921.45-0.520.831.115.806.250.00-6.06-8.330.0016.6711.1133.3333.337.695.713.481.065.835.564.352.082.388.334.176.670.000.000.000.000.0020.320.001.564.172.22-1.454.442.38-5.56-4.17-6.678.33-22.22-16.67-33.330.00

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Change From Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC-QLQ-C30) Score

EORTC QLQ-C30 is a validated and reliable self-report measure that consists of 30 questions that assess five aspects of patient functioning (physical, emotional, role, cognitive, and social), three symptom scales (fatigue, nausea and vomiting, pain), global health/quality of life, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). EORTC QLQ-C30 is scored according to the EORTC scoring manual (Fayers et al. 2001). All EORTC scales and single-item measures are linearly transformed so that each score has a range of 0-100. A high score for a functional/global health status scale represents a high or healthy level of functioning/HRQoL (Health-Related Quality of Life); however a high score for a symptom scale or item represents a high level of symptomatology or problems. A ≥10-point change in the symptoms subscale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: Baseline, Day 1 of each treatment cycle up to 30 days after last dose (up to approximately 55 months) (Cycle length = 21 days)

Interventionunits of a scale (Mean)
GHS/HRQoL Scale Score, BaselineGHS/HRQoL Scale Score, Week 6GHS/HRQoL Scale Score, Week 12GHS/HRQoL Scale Score, Week 18GHS/HRQoL Scale Score, Week 24GHS/HRQoL Scale Score, Week 30GHS/HRQoL Scale Score, Week 36GHS/HRQoL Scale Score, Week 42GHS/HRQoL Scale Score, Week 48GHS/HRQoL Scale Score, Week 57GHS/HRQoL Scale Score, Week 66GHS/HRQoL Scale Score, Week 75GHS/HRQoL Scale Score, Week 84GHS/HRQoL Scale Score, Week 93GHS/HRQoL Scale Score, Week 102GHS/HRQoL Scale Score, Week 111GHS/HRQoL Scale Score, Week 120GHS/HRQoL Scale Score, Week 129GHS/HRQoL Scale Score, Week 138GHS/HRQoL Scale Score, Week 147GHS/HRQoL Scale Score, Week 156GHS/HRQoL Scale Score, Week 165GHS/HRQoL Scale Score, Week 174GHS/HRQoL Scale Score, Week 183GHS/HRQoL Scale Score, Week 192GHS/HRQoL Scale Score, Week 201GHS/HRQoL Scale Score, Week 210GHS/HRQoL Scale Score, Safety Follow-Up VisitPhysical Functioning, BaselinePhysical Functioning, Week 6Physical Functioning, Week 12Physical Functioning, Week 18Physical Functioning, Week 24Physical Functioning, Week 30Physical Functioning, Week 36Physical Functioning, Week 42Physical Functioning, Week 48Physical Functioning, Week 57Physical Functioning, Week 66Physical Functioning, Week 75Physical Functioning, Week 84Physical Functioning, Week 93Physical Functioning, Week 102Physical Functioning, Week 111Physical Functioning, Week 120Physical Functioning, Week 129Physical Functioning, Week 138Physical Functioning, Week 147Physical Functioning, Week 156Physical Functioning, Week 165Physical Functioning, Week 174Physical Functioning, Week 183Physical Functioning, Week 192Physical Functioning, Week 201Physical Functioning, Week 210Physical Functioning, Safety Follow-Up VisitRole Functioning, BaselineRole Functioning, Week 6Role Functioning, Week 12Role Functioning, Week 18Role Functioning, Week 24Role Functioning, Week 30Role Functioning, Week 36Role Functioning, Week 42Role Functioning, Week 48Role Functioning, Week 57Role Functioning, Week 66Role Functioning, Week 75Role Functioning, Week 84Role Functioning, Week 93Role Functioning, Week 102Role Functioning, Week 111Role Functioning, Week 120Role Functioning, Week 129Role Functioning, Week 138Role Functioning, Week 147Role Functioning, Week 156Role Functioning, Week 165Role Functioning, Week 174Role Functioning, Week 183Role Functioning, Week 192Role Functioning, Week 201Role Functioning, Week 210Role Functioning, Safety Follow-Up VisitEmotional Functioning, BaselineEmotional Functioning, Week 6Emotional Functioning, Week 12Emotional Functioning, Week 18Emotional Functioning, Week 24Emotional Functioning, Week 30Emotional Functioning, Week 36Emotional Functioning, Week 42Emotional Functioning, Week 48Emotional Functioning, Week 57Emotional Functioning, Week 66Emotional Functioning, Week 75Emotional Functioning, Week 84Emotional Functioning, Week 93Emotional Functioning, Week 102Emotional Functioning, Week 111Emotional Functioning, Week 120Emotional Functioning, Week 129Emotional Functioning, Week 138Emotional Functioning, Week 147Emotional Functioning, Week 156Emotional Functioning, Week 165Emotional Functioning, Week 174Emotional Functioning, Week 183Emotional Functioning, Week 192Emotional Functioning, Week 201Emotional Functioning, Week 210Emotional Functioning, Safety Follow-Up VisitCognitive Functioning, BaselineCognitive Functioning, Week 6Cognitive Functioning, Week 12Cognitive Functioning, Week 18Cognitive Functioning, Week 24Cognitive Functioning, Week 30Cognitive Functioning, Week 36Cognitive Functioning, Week 42Cognitive Functioning, Week 48Cognitive Functioning, Week 57Cognitive Functioning, Week 66Cognitive Functioning, Week 75Cognitive Functioning, Week 84Cognitive Functioning, Week 93Cognitive Functioning, Week 102Cognitive Functioning, Week 111Cognitive Functioning, Week 120Cognitive Functioning, Week 129Cognitive Functioning, Week 138Cognitive Functioning, Week 147Cognitive Functioning, Week 156Cognitive Functioning, Week 165Cognitive Functioning, Week 174Cognitive Functioning, Week 183Cognitive Functioning, Week 192Cognitive Functioning, Week 201Cognitive Functioning, Week 210Cognitive Functioning, Safety Follow-Up VisitSocial Functioning, BaselineSocial Functioning, Week 6Social Functioning, Week 12Social Functioning, Week 18Social Functioning, Week 24Social Functioning, Week 30Social Functioning, Week 36Social Functioning, Week 42Social Functioning, Week 48Social Functioning, Week 57Social Functioning, Week 66Social Functioning, Week 75Social Functioning, Week 84Social Functioning, Week 93Social Functioning, Week 102Social Functioning, Week 111Social Functioning, Week 120Social Functioning, Week 129Social Functioning, Week 138Social Functioning, Week 147Social Functioning, Week 156Social Functioning, Week 165Social Functioning, Week 174Social Functioning, Week 183Social Functioning, Week 192Social Functioning, Week 201Social Functioning, Week 210Social Functioning, Safety Follow-Up VisitFatigue, BaselineFatigue, Week 6Fatigue, Week 12Fatigue, Week 18Fatigue, Week 24Fatigue, Week 30Fatigue, Week 36Fatigue, Week 42Fatigue, Week 48Fatigue, Week 57Fatigue, Week 66Fatigue, Week 75Fatigue, Week 84Fatigue, Week 93Fatigue, Week 102Fatigue, Week 111Fatigue, Week 120Fatigue, Week 129Fatigue, Week 138Fatigue, Week 147Fatigue, Week 156Fatigue, Week 165Fatigue, Week 174Fatigue, Week 183Fatigue, Week 192Fatigue, Week 201Fatigue, Week 210Fatigue, Safety Follow-Up VisitNausea and Vomiting, BaselineNausea and Vomiting, Week 6Nausea and Vomiting, Week 12Nausea and Vomiting, Week 18Nausea and Vomiting, Week 24Nausea and Vomiting, Week 30Nausea and Vomiting, Week 36Nausea and Vomiting, Week 42Nausea and Vomiting, Week 48Nausea and Vomiting, Week 57Nausea and Vomiting, Week 66Nausea and Vomiting, Week 75Nausea and Vomiting, Week 84Nausea and Vomiting, Week 93Nausea and Vomiting, Week 102Nausea and Vomiting, Week 111Nausea and Vomiting, Week 120Nausea and Vomiting, Week 129Nausea and Vomiting, Week 138Nausea and Vomiting, Week 147Nausea and Vomiting, Week 156Nausea and Vomiting, Week 165Nausea and Vomiting, Week 174Nausea and Vomiting, Week 183Nausea and Vomiting, Week 192Nausea and Vomiting, Week 201Nausea and Vomiting, Week 210Nausea and Vomiting, Safety Follow-Up VisitPain, BaselinePain, Week 6Pain, Week 12Pain, Week 18Pain, Week 24Pain, Week 30Pain, Week 36Pain, Week 42Pain, Week 48Pain, Week 57Pain, Week 66Pain, Week 75Pain, Week 84Pain, Week 93Pain, Week 102Pain, Week 111Pain, Week 120Pain, Week 129Pain, Week 138Pain, Week 147Pain, Week 156Pain, Week 165Pain, Week 174Pain, Week 183Pain, Week 192Pain, Week 201Pain, Week 210Pain, Safety Follow-Up VisitDyspnoea, BaselineDyspnoea, Week 6Dyspnoea, Week 12Dyspnoea, Week 18Dyspnoea, Week 24Dyspnoea, Week 30Dyspnoea, Week 36Dyspnoea, Week 42Dyspnoea, Week 48Dyspnoea, Week 57Dyspnoea, Week 66Dyspnoea, Week 75Dyspnoea, Week 84Dyspnoea, Week 93Dyspnoea, Week 102Dyspnoea, Week 111Dyspnoea, Week 120Dyspnoea, Week 129Dyspnoea, Week 138Dyspnoea, Week 147Dyspnoea, Week 156Dyspnoea, Week 165Dyspnoea, Week 174Dyspnoea, Week 183Dyspnoea, Week 192Dyspnoea, Week 201Dyspnoea, Week 210Dyspnoea, Safety Follow-Up VisitInsomnia, BaselineInsomnia, Week 6Insomnia, Week 12Insomnia, Week 18Insomnia, Week 24Insomnia, Week 30Insomnia, Week 36Insomnia, Week 42Insomnia, Week 48Insomnia, Week 57Insomnia, Week 66Insomnia, Week 75Insomnia, Week 84Insomnia, Week 93Insomnia, Week 102Insomnia, Week 111Insomnia, Week 120Insomnia, Week 129Insomnia, Week 138Insomnia, Week 147Insomnia, Week 156Insomnia, Week 165Insomnia, Week 174Insomnia, Week 183Insomnia, Week 192Insomnia, Week 201Insomnia, Week 210Insomnia, Safety Follow-Up VisitAppetite Loss, BaselineAppetite Loss, Week 6Appetite Loss, Week 12Appetite Loss, Week 18Appetite Loss, Week 24Appetite Loss, Week 30Appetite Loss, Week 36Appetite Loss, Week 42Appetite Loss, Week 48Appetite Loss, Week 57Appetite Loss, Week 66Appetite Loss, Week 75Appetite Loss, Week 84Appetite Loss, Week 93Appetite Loss, Week 102Appetite Loss, Week 111Appetite Loss, Week 120Appetite Loss, Week 129Appetite Loss, Week 138Appetite Loss, Week 147Appetite Loss, Week 156Appetite Loss, Week 165Appetite Loss, Week 174Appetite Loss, Week 183Appetite Loss, Week 192Appetite Loss, Week 201Appetite Loss, Week 210Appetite Loss, Safety Follow-Up VisitConstipation, BaselineConstipation, Week 6Constipation, Week 12Constipation, Week 18Constipation, Week 24Constipation, Week 30Constipation, Week 36Constipation, Week 42Constipation, Week 48Constipation, Week 57Constipation, Week 66Constipation, Week 75Constipation, Week 84Constipation, Week 93Constipation, Week 102Constipation, Week 111Constipation, Week 120Constipation, Week 129Constipation, Week 138Constipation, Week 147Constipation, Week 156Constipation, Week 165Constipation, Week 174Constipation, Week 183Constipation, Week 192Constipation, Week 201Constipation, Week 210Constipation, Safety Follow-Up VisitDiarrhoea, BaselineDiarrhoea, Week 6Diarrhoea, Week 12Diarrhoea, Week 18Diarrhoea, Week 24Diarrhoea, Week 30Diarrhoea, Week 36Diarrhoea, Week 42Diarrhoea, Week 48Diarrhoea, Week 57Diarrhoea, Week 66Diarrhoea, Week 75Diarrhoea, Week 84Diarrhoea, Week 93Diarrhoea, Week 102Diarrhoea, Week 111Diarrhoea, Week 120Diarrhoea, Week 129Diarrhoea, Week 138Diarrhoea, Week 147Diarrhoea, Week 156Diarrhoea, Week 165Diarrhoea, Week 174Diarrhoea, Week 183Diarrhoea, Week 192Diarrhoea, Week 201Diarrhoea, Week 210Diarrhoea, Safety Follow-Up VisitFinancial Difficulties, BaselineFinancial Difficulties, Week 6Financial Difficulties, Week 12Financial Difficulties, Week 18Financial Difficulties, Week 24Financial Difficulties, Week 30Financial Difficulties, Week 36Financial Difficulties, Week 42Financial Difficulties, Week 48Financial Difficulties, Week 57Financial Difficulties, Week 66Financial Difficulties, Week 75Financial Difficulties, Week 84Financial Difficulties, Week 93Financial Difficulties, Week 102Financial Difficulties, Week 111Financial Difficulties, Week 120Financial Difficulties, Week 129Financial Difficulties, Week 138Financial Difficulties, Week 147Financial Difficulties, Week 156Financial Difficulties, Week 165Financial Difficulties, Week 174Financial Difficulties, Week 183Financial Difficulties, Week 192Financial Difficulties, Week 201Financial Difficulties, Week 210Financial Difficulties, Safety Follow-Up Visit
Atezolizumab54.702.092.764.204.924.328.206.176.448.566.823.8511.402.084.691.792.38-2.981.194.17-2.38-3.13-2.38-6.67-4.170.00-16.67-9.8561.34-2.930.173.023.494.256.983.587.447.594.654.873.701.672.402.383.33-1.03-0.48-0.48-4.76-3.61-1.902.67-3.33-3.33-20.00-9.7062.53-2.63-1.78-0.961.25-0.202.151.544.923.150.51-0.643.70-1.672.08-3.57-1.19-1.19-2.38-3.57-2.38-10.42-7.14-10.00-16.670.000.00-22.7374.202.121.243.824.133.152.022.015.045.784.290.326.582.924.693.571.792.984.175.362.38-1.042.38-1.67-2.08-4.17-16.676.8281.39-1.67-1.792.620.48-2.01-0.54-4.94-1.89-3.15-4.04-5.13-3.513.334.174.760.000.00-2.381.194.766.250.003.330.000.000.00-16.6771.321.301.585.605.084.823.01-0.311.893.605.565.772.638.339.382.387.14-2.382.387.144.76-6.257.146.67-4.17-25.00-50.001.5241.623.370.53-1.79-3.14-2.88-4.06-2.67-6.72-3.30-2.53-4.70-6.79-5.56-5.56-0.79-2.38-2.78-1.59-3.17-1.591.39-4.764.445.56-5.56-11.110.008.280.901.12-0.41-1.87-2.382.121.54-1.552.25-1.012.560.88-1.67-2.084.76-1.190.00-2.38-2.38-2.38-2.08-2.38-3.330.000.000.0013.6431.52-0.98-3.58-5.51-6.70-5.36-7.41-5.25-9.85-7.21-13.13-5.77-15.79-7.50-17.71-14.29-15.48-10.71-15.48-13.10-14.29-10.42-11.90-13.33-12.50-25.00-16.679.0936.17-1.360.45-1.91-5.03-4.37-6.99-8.64-7.58-9.01-3.03-5.13-9.260.004.17-7.690.002.38-2.38-4.760.00-4.174.766.670.000.000.0024.2430.50-1.95-1.78-4.37-6.23-3.17-3.17-3.09-6.20-9.91-8.08-8.97-7.41-8.33-10.42-9.52-11.90-9.52-16.67-14.29-4.760.00-9.52-13.33-8.33-33.33-33.3312.1231.631.06-4.22-7.38-9.43-12.30-11.11-7.41-10.85-6.31-9.09-10.26-17.54-10.00-10.42-7.14-9.52-7.14-9.52-16.670.000.00-9.52-13.338.3316.670.00-9.0921.20-0.45-2.46-6.01-5.61-6.75-7.94-4.94-10.61-15.32-13.13-5.13-3.51-8.33-10.42-7.14-4.76-7.14-9.52-11.90-14.29-8.33-14.29-13.330.0016.670.003.035.63-0.611.80-0.830.002.010.00-3.09-0.760.00-4.04-5.131.751.670.007.144.762.38-4.76-4.76-4.760.00-9.52-13.330.000.000.006.0622.22-3.20-4.95-4.41-4.76-3.21-2.69-1.85-0.76-4.500.001.283.510.002.082.38-2.38-2.382.38-2.38-9.524.17-9.520.000.0016.670.00-3.03

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OS Rates at the 6, 12, 18, 24-Months Timepoints

OS rate at 6, 12, 18 and 24 months were estimated for each treatment arm. (NCT03191786)
Timeframe: 6, 12, 18 and 24 months

,
InterventionPercentage (Number)
6 Months12 Months18 Months24 Months
Atezolizumab64.043.731.424.3
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)57.538.624.012.4

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Time to Deterioration (TTD) in Patient-Reported Lung Cancer Symptoms as Assessed by EORTC QLQ-C30 Score

TTD with use of the EORTC is defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score is perceived by participants as clinically significant (Osoba et al. 1998). (NCT03191786)
Timeframe: From baseline up to approximately 55 months

,
InterventionMonths (Median)
DyspnoeaFatigue
AtezolizumabNA13.5
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)NA8.4

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Time to Deterioration in Patient-Reported Lung Cancer Symptoms As Assessed by EORTC QLQ-LC13 Score

TTD with use of the EORTC is defined as the time from randomization to the first confirmed clinically meaningful deterioration in EORTC symptom scores. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a = 10-point increase above baseline in a symptom score that must be held for at least two consecutive assessments or an initial = 10-point increase above baseline followed by either (a) death within 6 weeks from the last assessment through Week 48 or (b) death within 9 weeks from the last assessment from Week 48 thereafter. A = 10-point change in the EORTC scale score is perceived by participants as clinically significant. (NCT03191786)
Timeframe: From baseline up to approximately 55 months

,
InterventionMonths (Median)
CoughChest PainDyspnoeaArm and/or Shoulder PainComposite of Cough, Dyspnea and Chest Pain
AtezolizumabNANA17.321.38.3
Single Agent Chemotherapy (Vinorelbine or Gemcitabine)21.4NA8.313.94.2

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Overall Survival

Overall survival is defined as the time from date of randomization to death due to any cause. (NCT03262935)
Timeframe: baseline until final Overall Survival analysis data cut-off date of 30June2022

Interventionmonths (Median)
(Vic-)Trastuzumab Duocarmazine21.0
Physician's Choice19.5

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Objective Response Rate

Objective Response Rate is defined as the proportion of patients with a centrally assessed best overall response of complete response or partial response according to RECIST v1.1. (NCT03262935)
Timeframe: baseline until primary analysis data cut-off date of 31March2021

Interventionpercentage of patients (Number)
(Vic-)Trastuzumab Duocarmazine27.8
Physician's Choice29.5

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Investigator Assessed Progression Free Survival

Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by investigator assessment according to RECIST v1.1 or death due to any cause, whichever occurred earlier. (NCT03262935)
Timeframe: baseline until primary analysis data cut-off date of 31March2021

Interventionmonths (Median)
(Vic-)Trastuzumab Duocarmazine6.9
Physician's Choice4.6

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Progression Free Survival

Progression-free survival is defined as the time from the date of randomization to the date of first documented disease progression by central assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurred earlier. (NCT03262935)
Timeframe: baseline until primary analysis data cut-off date of 31March2021

Interventionmonths (Median)
(Vic-)Trastuzumab Duocarmazine7.0
Physician's Choice4.9

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Percentage of Participants With Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

ORR was defined as the percentage of participants with observed tumor response of complete response (CR), or partial response (PR) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The percentages of participants are rounded off to the nearest single decimal point. (NCT03386721)
Timeframe: Baseline up to disease progression or study treatment discontinuation (up to 38 months)

Interventionpercentage of participants (Number)
NSCLC: Part I Cohort A (QW/Q2W)19.2
NSCLC: Part I Cohort B (QW/Q2W)6.3
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)0
NSCLC: Part I Cohort D, Arm 2 (Q3W)0
NSCLC: Part I Cohort F (Q3W)4.8
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)66.7
NSCLC: Part II Cohort E, Arm 2 (Q3W)50.0
SCCHN: Part III Cohort G (Q3W)18.2
SCCHN: Part III Cohort H (Q3W)3.6
ESCC: Part III Cohort I (Q3W)21.9
CSCC: Part III Cohort J (Q3W)27.3
SCCHN: Part III Cohort K (QW/Q2W)4.0
ESCC: Part III Cohort M (QW/Q2W)0
CSCC: Part III Cohort N (QW/Q2W)0

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Percentage of Participants With Disease Control Rate (DCR) Determined According to RECIST Version 1.1

DCR was defined as the percentage of participants with observed tumor response of CR, PR or stable disease (SD) determined according to RECIST version 1.1. CR was defined as the disappearance of all target lesions with reduction in target/non-target pathological lymph nodes to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline (nadir). The percentages of participants are rounded off to the nearest single decimal point. (NCT03386721)
Timeframe: Baseline up to disease progression or study treatment discontinuation (up to 38 months)

Interventionpercentage of participants (Number)
NSCLC: Part I Cohort A (QW/Q2W)53.8
NSCLC: Part I Cohort B (QW/Q2W)62.5
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)0
NSCLC: Part I Cohort D, Arm 2 (Q3W)20.0
NSCLC: Part I Cohort F (Q3W)57.1
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)66.7
NSCLC: Part II Cohort E, Arm 2 (Q3W)50.0
SCCHN: Part III Cohort G (Q3W)50.0
SCCHN: Part III Cohort H (Q3W)14.3
ESCC: Part III Cohort I (Q3W)43.8
CSCC: Part III Cohort J (Q3W)68.2
SCCHN: Part III Cohort K (QW/Q2W)36.0
ESCC: Part III Cohort M (QW/Q2W)50.0
CSCC: Part III Cohort N (QW/Q2W)0

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Percentage of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. (NCT03386721)
Timeframe: Baseline up to end of the study (up to approximately 47 months)

Interventionpercentage of participants (Number)
NSCLC: Part I Cohort A (QW/Q2W)100
NSCLC: Part I Cohort B (QW/Q2W)100
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)100
NSCLC: Part I Cohort D, Arm 2 (Q3W)100
NSCLC: Part I Cohort D, Arm 3 (Q3W)100
NSCLC: Part I Cohort F (Q3W)100
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)100
NSCLC: Part II Cohort E, Arm 2 (Q3W)100
SCCHN: Part III Cohort G (Q3W)100
SCCHN: Part III Cohort H (Q3W)100
ESCC: Part III Cohort I (Q3W)100
CSCC: Part III Cohort J (Q3W)100
SCCHN: Part III Cohort K (QW/Q2W)100
ESCC: Part III Cohort M (QW/Q2W)100
CSCC: Part III Cohort N (QW/Q2W)100

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Overall Survival (OS)

OS was defined as the time from the first dose of study treatment to the time of death from any cause on study. Participants who were still alive at the time of analysis were censored at the last date known alive. (NCT03386721)
Timeframe: From first dose of study treatment up to death due to any cause (up to approximately 47 months)

Interventionmonths (Median)
NSCLC: Part I Cohort A (QW/Q2W)NA
NSCLC: Part I Cohort B (QW/Q2W)NA
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)NA
NSCLC: Part I Cohort D, Arm 2 (Q3W)NA
NSCLC: Part I Cohort F (Q3W)NA
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)NA
NSCLC: Part II Cohort E, Arm 2 (Q3W)NA
SCCHN: Part III Cohort G (Q3W)NA
SCCHN: Part III Cohort H (Q3W)NA
ESCC: Part III Cohort I (Q3W)NA
CSCC: Part III Cohort J (Q3W)NA
SCCHN: Part III Cohort K (QW/Q2W)NA
ESCC: Part III Cohort M (QW/Q2W)NA
CSCC: Part III Cohort N (QW/Q2W)NA

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Progression-Free Survival (PFS) According to RECIST Version 1.1

PFS was defined as the time from study treatment initiation (Cycle 1 Day 1 [1 cycle=14 days for QW/Q2W cohorts; 1 cycle=21 days for Q3W cohorts]) to the first occurrence of documented disease progression (based on Investigator's assessment) or death from any cause during treatment, whichever occurs first. Participants that did not have documented progressive disease or death during the study were censored at the day of the last tumor assessment. (NCT03386721)
Timeframe: Study treatment initiation up to disease progression or study treatment discontinuation (up to 38 months)

Interventionmonths (Median)
NSCLC: Part I Cohort A (QW/Q2W)3.5
NSCLC: Part I Cohort B (QW/Q2W)3.7
NSCLC: Part I Cohort D, Arm 1 (QW/Q2W)2.0
NSCLC: Part I Cohort D, Arm 2 (Q3W)2.0
NSCLC: Part I Cohort F (Q3W)3.5
NSCLC: Part II Cohort E, Arm 1 (QW/Q2W)NA
NSCLC: Part II Cohort E, Arm 2 (Q3W)10.5
SCCHN: Part III Cohort G (Q3W)2.5
SCCHN: Part III Cohort H (Q3W)1.9
ESCC: Part III Cohort I (Q3W)1.9
CSCC: Part III Cohort J (Q3W)3.7
SCCHN: Part III Cohort K (QW/Q2W)1.9
ESCC: Part III Cohort M (QW/Q2W)2.6
CSCC: Part III Cohort N (QW/Q2W)1.9

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