Page last updated: 2024-11-06

gallium nitrate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

gallium nitrate: RN given refers to parent cpd [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID61635
MeSH IDM0088700

Synonyms (23)

Synonym
13494-90-1
gallium nitrate
nitric acid, gallium salt
gallium nitrate anhydrous
einecs 236-815-5
ccris 4493
nitric acid, gallium(3+) salt
nitric acid, gallium salt, anhydrate
DB05260
gallium nitrate (anhydrous)
nitric acid, gallium salt (3:1)
unii-y2v2r4w9tq
y2v2r4w9tq ,
AKOS015902357
gallium nitrate [who-dd]
gallium nitrate [mi]
gallium nitrate (ga(no3)3)
DTXSID0043923
CHPZKNULDCNCBW-UHFFFAOYSA-N
mfcd00011016
sr-01000944456
SR-01000944456-1
galliumnitrate

Research Excerpts

Overview

Gallium nitrate is a metal compound that is presently approved for the treatment of hypercalcaemia associated with malignancy. Gallium Nitrate (GN) is an inhibitor of bone resorption and thereby may result in a change in coupled bone formation.

ExcerptReferenceRelevance
"Gallium nitrate is a metal compound that is presently approved for the treatment of hypercalcaemia associated with malignancy."( Gallium nitrate for the treatment of non-Hodgkin's lymphoma.
Chitambar, CR, 2004
)
2.49
"Gallium nitrate is an approved therapy for symptomatic, cancer-related hypercalcemia unresponsive to adequate hydration, the most common life-threatening metabolic disorder of cancer. "( Treating cancer-related hypercalcemia with gallium nitrate.
Leyland-Jones, B,
)
1.84
"Gallium nitrate is a metallodrug with clinical efficacy in non-Hodgkin's lymphoma. "( Gallium-induced cell death in lymphoma: role of transferrin receptor cycling, involvement of Bax and the mitochondria, and effects of proteasome inhibition.
Chitambar, CR; Matsuyama, S; Wereley, JP, 2006
)
1.78
"Gallium nitrate is a new antineoplastic agent that has shown activity in a number of in vitro tumor systems. "( Pharmacokinetics of gallium nitrate in man.
Alcock, N; Brown, J; Kelsen, DP; Yeh, S; Young, C, 1980
)
2.03
"Gallium nitrate is a potent antiresorptive drug that has been extensively tested in patients with accelerated bone turnover. "( A multicenter trial of low dose gallium nitrate in patients with advanced Paget's disease of bone.
Bitton, R; Bockman, RS; Bosco, BJ; Chausmer, A; Eyre, DR; Kotler, J; Levenson, D; Singer, F; Siris, E; Wilhelm, F, 1995
)
2.02
"Gallium nitrate (GN) is an inhibitor of bone resorption and thereby may result in a change in coupled bone formation. "( Effect of gallium nitrate in vitro and in normal rats.
Baran, DT; Jenis, LG; Lian, JB; Stein, GS; Waud, CE, 1993
)
2.13
"Gallium nitrate is a group IIIa metal that was found to be active in animal species. "( Phase II trial of gallium nitrate in previously treated patients with small cell lung cancer.
Baselga, J; Heelan, RT; Kris, MG; Phillips, M; Scher, HI, 1993
)
2.06
"Gallium nitrate is an antihypercalcemic agent with established actions on bone. "( Ga3+ inhibits parathyroid hormone release without interacting with the Ca2+ receptor of the parathyroid cell.
Akerström, G; Gylfe, E; Hellman, P; Ljunggren, O; Ljunghall, S; Rastad, J; Ridefelt, P, 1992
)
1.73
"Gallium nitrate is an effective antihypercalcemic and antiresorptive agent. "( Effects of gallium nitrate on calcium transients in UMR-106 rat osteoblastic osteosarcoma cells.
Lakatos, P; Stern, PH; Tatrai, A, 1992
)
2.12
"Gallium nitrate is a heavy metal anticancer agent that has demonstrated widespread activity in a number of phase I studies. "( Gallium nitrate in advanced bladder carcinoma: Southwest Oncology Group study.
Baker, LH; Bukowski, RM; Costanzi, JH; Crawford, ED; Saiers, JH, 1991
)
3.17
"Gallium nitrate (GN) is an agent used in the treatment of hypercalcemia. "( Gallium nitrate inhibits bone resorption and collagen synthesis in neonatal mouse calvariae.
Lakatos, P; Mong, S; Stern, PH, 1991
)
3.17
"Gallium nitrate is a clinically effective agent for the treatment of cancer related hypercalcemia. "( Bone particles from gallium-treated rats are resistant to resorption in vivo.
Bockman, RS; Boskey, AL; Donnelly, R; Doty, SB, 1991
)
1.72
"Gallium nitrate is a new drug which both inhibits bone resorption and increases calcium content of bone."( Gallium nitrate for acute treatment of cancer-related hypercalcemia: clinicopharmacological and dose response analysis.
Alcock, NW; Bockman, RS; Skelos, A; Warrell, RP, 1986
)
2.44

Effects

Gallium nitrate has been shown to be an effective treatment for patients with cancer-related hypercalcemia. It has modest activity in previously treated patients with epithelial ovarian cancer. Gallium Nitrate has substantial single-agent activity in the treatment of advanced lymphoma.

ExcerptReferenceRelevance
"Gallium nitrate has been reported to reserve immunosuppressive activities."( Gallium nitrate ameliorates type II collagen-induced arthritis in mice.
Cho, KR; Choi, IW; Choi, JH; Kim, MH; Kim, YJ; Lee, JH; Lee, WJ; Lim, JG; Park, SG; Roh, KH; Seo, SK, 2014
)
2.57
"Gallium nitrate has substantial single-agent activity in the treatment of advanced lymphoma, particularly diffuse large cell lymphoma, small lymphocytic lymphoma, and follicular lymphoma."( Gallium nitrate revisited.
Chitambar, CR, 2003
)
2.48
"Gallium nitrate has been shown to be an effective treatment for patients with cancer-related hypercalcemia. "( The effects of gallium nitrate on bone resorption.
Bockman, R, 2003
)
2.11
"Gallium nitrate has significant activity as a single agent in the treatment of advanced bladder cancer, including activity in heavily pretreated patients and patients previously treated with MVAC or single-agent cisplatin."( Gallium nitrate in the treatment of bladder cancer.
Einhorn, L, 2003
)
2.48
"Gallium nitrate has substantial single-agent activity in the treatment of patients with advanced lymphoma and has also shown activity when used in combination with other agents."( Gallium nitrate in the treatment of lymphoma.
Straus, DJ, 2003
)
2.48
"Gallium nitrate has recently become commercially available, thus reopening the door for clinical trials evaluating it as an antineoplastic agent."( Gallium compounds as antineoplastic agents.
Chitambar, CR, 2004
)
1.04
"Gallium nitrate has demonstrated activity against lymphoma and bladder cancer, which is likely the result of selective targeting of these malignancies. "( Gallium compounds as antineoplastic agents.
Chitambar, CR, 2004
)
1.77
"Gallium nitrate has activity in lymphomas and should be combined with more active drugs for patients who have undergone less intensive prior therapy."( Gallium nitrate in malignant lymphoma: a Southwest Oncology Group study.
Baker, LH; Jones, SE; Stephens, RL; Weick, JK, 1983
)
2.43
"Gallium nitrate has demonstrated significant antineoplastic activity toward human medulloblastoma in vitro and in vivo and may prove to be an optimal chemotherapeutic agent in treating medulloblastoma microscopic disease."( Gallium nitrate delays the progression of microscopic disease in a human medulloblastoma murine model.
Bajic, DM; Chitambar, CR; Flores, RE; McAuliffe, TL; Schmidt, MH; Whelan, HT; Williams, MB, 1994
)
2.45
"Gallium nitrate has modest activity in patients with nonsquamous cell carcinoma of the cervix."( A phase II trial of gallium nitrate (NSC #15200) in nonsquamous cell carcinoma of the cervix. A Gynecologic Oncology Group study.
Blessing, JA; Homesley, HD; Malfetano, JH, 1995
)
1.34
"Gallium nitrate has been used systemically for some malignancies in clinical trials. "( Cytotoxicity of gallium nitrate in vitro using bladder cancer cells.
Aoyagi, T; Bander, NH, 1995
)
2.08
"Gallium nitrate has been reported to target tumor tissue in vitro and some preliminary data suggests activity in patients with prostate cancer."( In vitro effect of gallium nitrate when combined with ketoconazole in the prostate cancer cell line PC-3.
Dixon, SC; Figg, WD; Giordano, C; Lush, RM; Reed, E; Venzon, D; Zalles, A, 1997
)
1.35
"Gallium nitrate (GN) has been shown to inhibit T cell-mediated inflammatory disease. "( Effect of gallium nitrate on experimental autoimmune uveitis.
Chan, CC; Gerber, N; Gery, I; Kozhich, AT; Lobanoff, MC; Mullet, DI; Whitcup, SM, 1997
)
2.14
"Gallium nitrate has modest activity in previously treated patients with epithelial ovarian cancer."( A phase II trial of gallium nitrate (NSC #15200) in previously treated ovarian carcinoma. A Gynecologic Oncology Group Study.
Adelson, MD; Blessing, JA; Malfetano, JH, 1991
)
1.33
"Gallium nitrate has minimal activity in patients with previously untreated squamous cell carcinoma of the cervix."( A phase II trial of gallium nitrate (NSC #15200) in advanced or recurrent squamous cell carcinoma of the cervix. A Gynecologic Oncology Group study.
Blessing, JA; Hanjani, P; Homesley, HD; Malfetano, JH, 1991
)
1.33

Actions

Gallium nitrate did not inhibit CD45, a PTPase found in the membranes of hemopoietic lineage cells such as Jurkat cells. It also inhibited the type II collagen-specific IgG2a-isotype autoantibodies.

ExcerptReferenceRelevance
"Gallium nitrate inhibited the increase of CD4(+) T cell populations (p<0.05) and also inhibited the type II collagen-specific IgG2a-isotype autoantibodies (p<0.05)."( Gallium nitrate ameliorates type II collagen-induced arthritis in mice.
Cho, KR; Choi, IW; Choi, JH; Kim, MH; Kim, YJ; Lee, JH; Lee, WJ; Lim, JG; Park, SG; Roh, KH; Seo, SK, 2014
)
2.57
"Gallium nitrate did not inhibit CD45, a PTPase found in the membranes of hemopoietic lineage cells such as Jurkat cells."( Inhibition of protein tyrosine phosphatase by the antitumor agent gallium nitrate.
Abraham, RT; Berggren, MM; Burns, LA; Powis, G, 1993
)
1.24

Treatment

Gallium nitrate treatment could not block acute rejection of skin allografts, but interfered with sensitization for self-restricted, but not allorestricted, DTH responses in these recipients. Treatment with gallium Nitrate (100 mg/m2 daily for 5 days) significantly reduced serum calcium, serum phosphate, urinary calcium, and the ratio of maximum tubular reabsorption of phosphate to glomerular filtration rate in each patient.

ExcerptReferenceRelevance
"Gallium nitrate-treated tumor-bearing mice had a significant decrease in serum calcium as compared with tumor-bearing controls."( Effects of humoral hypercalcemia of malignancy and gallium nitrate on thyroid C cells in nude mice: immunohistochemical and ultrastructural investigations.
Capen, CC; Merryman, JI; Okada, H; Rosol, TJ, 1994
)
1.26
"Gallium nitrate treatment could not block acute rejection of skin allografts, but interfered with sensitization for self-restricted, but not allorestricted, DTH responses in these recipients."( Alloreactive delayed-type hypersensitivity in graft recipients: complexity of responses and divergence from acute rejection.
Orosz, CG; Sirak, J; VanBuskirk, AM; Wakely, E, 1997
)
1.02
"Gallium nitrate treatment reduced overall tumor growth rate and reduced actual tumor size."( Antineoplastic effects of gallium nitrate on human medulloblastoma in vivo.
Anderson, GS; Chan, BK; Chitambar, CR; Hunter, K; Kubacki, D; Schmidt, MH; Segura, AD; Whelan, HT,
)
1.15
"Treatment with gallium nitrate (100 mg/m2 daily for 5 days, intravenously in 5% glucose) significantly reduced serum calcium, serum phosphate, urinary calcium, and the ratio of maximum tubular reabsorption of phosphate to glomerular filtration rate in each patient."( Use of gallium to treat Paget's disease of bone: a pilot study.
Apseloff, G; Gerber, N; Matkovic, V; Shepard, DR, 1990
)
0.62
"Treatment with gallium nitrate for five to seven days caused a median reduction in 24-hour urinary calcium excretion of 66% relative to baseline measurements (P less than .01)."( Gallium nitrate inhibits accelerated bone turnover in patients with bone metastases.
Alcock, NW; Bockman, RS; Warrell, RP, 1987
)
2.06

Toxicity

ExcerptReferenceRelevance
" Since there are very limited published animal toxicity data available, this study was conducted to investigate the potential adverse developmental effects of this drug."( Developmental toxicity evaluation of gallium nitrate in mice.
Corbella, J; Domingo, JL; Gómez, M; Sánchez, DJ, 1992
)
0.56
" The addition of ferric citrate greatly reduced the toxic effect of the gallium salt."( Tumor cell toxicity of stable gallium nitrate: enhancement by transferrin and protection by iron.
Larson, SM; Nelson, NJ; Rasey, JS, 1982
)
0.55
"The use of mercury in dental amalgam restorations has become the subject of political controversy despite its long history of safe clinical use, and alternative materials based on gallium and indium rather than mercury have been developed."( Cytotoxicity of gallium and indium ions compared with mercuric ion.
Chandler, JE; Ellender, G; Messer, HH, 1994
)
0.29

Dosage Studied

Pamidronate offers a more convenient dosing regimen, is less frequently associated with nephrotoxicity, and is less expensive. Changes in the dosage of M-VAC; 5-fluorouracil, alpha-interferon, and cisplatin; and gallium nitrate show promise.

ExcerptRelevanceReference
" Changes in the dosage of M-VAC; 5-fluorouracil, alpha-interferon, and cisplatin; and gallium nitrate show promise."( Treatment of chemotherapy-refractory metastatic urothelial tumors.
Logothetis, C, 1992
)
0.51
" A dose-response study showed that with 24 h preincubation, 5, 3, and 1 microgram/ml of GN inhibited 81, 62, and 0% of PTH-induced calcium release."( Gallium nitrate inhibits bone resorption and collagen synthesis in neonatal mouse calvariae.
Lakatos, P; Mong, S; Stern, PH, 1991
)
1.72
" A dose-response relationship was suggested because no responses were observed in 17 patients who received less than 350 mg/m2/d."( Continuous infusion gallium nitrate for patients with advanced refractory urothelial tract tumors.
Bajorin, DF; Bosl, GJ; Dershaw, DD; Heinemann, MH; Scher, HI; Seidman, AD; Silverberg, M; Sternberg, CN, 1991
)
0.6
" Compared with gallium nitrate, pamidronate offers a more convenient dosing regimen, is less frequently associated with nephrotoxicity, and is less expensive."( Update on the medical treatment of hypercalcemia of malignancy.
Hall, TG; Schaiff, RA, 1993
)
0.64
"Eight patients were enrolled: 4 patients at the 200 mg/m(2)/day dose level and 4 patients at the lower dosage (150 mg/m(2)/day)."( A phase II trial of gallium nitrate in patients with androgen-metastatic prostate cancer.
Abornathy, T; Figg, WD; Headlee, D; Horti, J; Lush, RM; Reed, E; Reid, R; Sausville, EA; Senderowicz, AM, 1999
)
0.63
" At a dosage of 300 mg/m(2) daily by continuous infusion for 5 to 7 days every 3 weeks, toxicity has been acceptable in the treatment of patients with refractory disease."( Gallium nitrate in the treatment of bladder cancer.
Einhorn, L, 2003
)
1.76
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (249)

TimeframeStudies, This Drug (%)All Drugs %
pre-199034 (13.65)18.7374
1990's111 (44.58)18.2507
2000's45 (18.07)29.6817
2010's47 (18.88)24.3611
2020's12 (4.82)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 48.82

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 strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index48.82 (24.57)
Research Supply Index5.69 (2.92)
Research Growth Index4.82 (4.65)
Search Engine Demand Index76.42 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (48.82)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials29 (10.90%)5.53%
Reviews54 (20.30%)6.00%
Case Studies8 (3.01%)4.05%
Observational0 (0.00%)0.25%
Other175 (65.79%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study) [NCT04294043]Phase 140 participants (Anticipated)Interventional2021-06-17Recruiting
A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients [NCT01093521]Phase 120 participants (Actual)Interventional2010-04-30Completed
A Phase II Multicenter Study of Gallium Nitrate in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma [NCT00054808]Phase 240 participants Interventional2002-06-30Completed
A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study) [NCT02354859]Phase 2119 participants (Actual)Interventional2016-03-31Completed
Phase II Evaluation of Gallium Nitrate (NSC 15200) in Non-Hodgkin's Lymphoma in Patients With Acquired Immunodeficiency Syndrome [NCT00002578]Phase 235 participants (Anticipated)Interventional1994-08-31Completed
GALLIUM NITRATE FOR THE TREATMENT OF MALIGNANT TUMORS, A PHASE I STUDY [NCT00002543]Phase 13 participants (Anticipated)Interventional1995-02-28Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT01093521 (11) [back to overview]Change in Lung Function From Baseline to Day 15
NCT01093521 (11) [back to overview]Change in P. Aeruginosa Density From Baseline to Day 56
NCT01093521 (11) [back to overview]Change in P. Aeruginosa Density From Baseline to Day 8
NCT01093521 (11) [back to overview]Change in Spirometry as Measured by FVC From Baseline to Day 8
NCT01093521 (11) [back to overview]Change in Spirometry From Baseline to Day 28
NCT01093521 (11) [back to overview]Change in Spirometry From Baseline to Day 56
NCT01093521 (11) [back to overview]Change in Spirometry From Baseline to Day 8
NCT01093521 (11) [back to overview]Change in Sputum P. Aeruginosa Density From Baseline to Day 15
NCT01093521 (11) [back to overview]Number of Events When Study Drug Infusion Was Stopped Early
NCT01093521 (11) [back to overview]Number of Serious Adverse Events
NCT01093521 (11) [back to overview]Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)
NCT02354859 (6) [back to overview]Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56
NCT02354859 (6) [back to overview]Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), From Baseline to Day 56
NCT02354859 (6) [back to overview]Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28
NCT02354859 (6) [back to overview]Relative Change in FEV1 (Liters) From Baseline to Day 56
NCT02354859 (6) [back to overview]Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
NCT02354859 (6) [back to overview]Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Change in Lung Function From Baseline to Day 15

Change in FEV1 in liters from baseline to day 15 (NCT01093521)
Timeframe: 15 days from starting dose

Interventionliters (Mean)
IV Gallium (Ganite®) Infusion0.13

[back to top]

Change in P. Aeruginosa Density From Baseline to Day 56

Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 56 (NCT01093521)
Timeframe: 56 days from starting dose

Interventioncolony counts in millions per gm sputum (Mean)
IV Gallium (Ganite®) Infusion-76.0

[back to top]

Change in P. Aeruginosa Density From Baseline to Day 8

Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 8 (NCT01093521)
Timeframe: 8 days from starting dose

Interventioncolony counts in millions per gm sputum (Mean)
IV Gallium (Ganite®) Infusion21.1

[back to top]

Change in Spirometry as Measured by FVC From Baseline to Day 8

Change from baseline in lung function assessed by FVC in liters after treatment with IV Ga at day 8 (NCT01093521)
Timeframe: 8 days from starting dose

Interventionliters (Mean)
IV Gallium (Ganite®) Infusion0.16

[back to top]

Change in Spirometry From Baseline to Day 28

Change in lung function as measured by FEV1 in liters from baseline to day 28 (NCT01093521)
Timeframe: 28 days from starting dose

Interventionliters (Mean)
IV Gallium (Ganite®) Infusion0.10

[back to top]

Change in Spirometry From Baseline to Day 56

Change in lung function as measured by FEV1 in liters from baseline to day 56 (NCT01093521)
Timeframe: 56 days from starting dose

Interventionliters (Mean)
IV Gallium (Ganite®) Infusion0.12

[back to top]

Change in Spirometry From Baseline to Day 8

Change in spirometry as measured by FEV1 in liters from baseline to day 8 (NCT01093521)
Timeframe: 8 days

Interventionliters (Mean)
IV Gallium (Ganite®) Infusion0.13

[back to top]

Change in Sputum P. Aeruginosa Density From Baseline to Day 15

Change in sputum microbiology (specifically P. aeruginosa density based on quantitative cultures) from baseline to day 15 (NCT01093521)
Timeframe: 15 days from starting dose

Interventioncolony counts in millions per gm sputum (Mean)
IV Gallium (Ganite®) Infusion-5.5

[back to top]

Number of Events When Study Drug Infusion Was Stopped Early

Tolerability as measured by adverse events of a 5 day continuous infusion of IV Gallium as assessed by stopping study drug infusion (NCT01093521)
Timeframe: 6 days from starting dose

InterventionNumber of times study drug interupted (Number)
IV Gallium (Ganite®) Infusion0

[back to top]

Number of Serious Adverse Events

Safety as measured by serous adverse events (NCT01093521)
Timeframe: 56 days from starting dose

InterventionSerious Adverse Events (Number)
IV Gallium (Ganite®) Infusion0

[back to top]

Pharmacokinetic Assessment of a 5 Day Infusion of Gallium Nitrate (IV Ganite®)

"To assess the summed area under the curves of a 5 day infusion of IV Ga from day 1 to day 28 at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~To assess the safety of a 5 day infusion of IV Ga at two doses: 100 mg/m2/day in adult subjects with CF; 200 mg/m2/day in adult subjects with CF.~Safety and tolerability of 5 days of treatment with IV administered gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day." (NCT01093521)
Timeframe: Day 1 at t=1, 2 and 6 hours, Day 3, Day 6 at t= 1, 2, 8, and 12, Day 14 and Day 28

Interventionug*hr/mL (Mean)
IV Gallium (Ganite®) Infusion 100 mg/m2/Day503
IV Gallium (Ganite®) Infusion 200 mg/m2/Day537

[back to top]

Absolute Change in P. Aeruginosa Sputum Density (log10 (CFU)) From Baseline to Day 56

Difference between treatment groups in the absolute change in P. aeruginosa sputum density (log10 (CFU)) from Baseline to Day 56 based on quantitative cultures. (NCT02354859)
Timeframe: Day 1 to Day 56

Interventionlog10 (CFU) (Mean)
Gallium-1.06
Placebo-0.33

[back to top]

Absolute Change in Respiratory Symptoms, as Measured by the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), From Baseline to Day 56

Difference between treatment groups in the absolute change in respiratory symptoms, as measured by the the CF Respiratory Symptoms Diary-Chronic Respiratory Infection Symptom Severity Score (CFRSD-CRISS), from Baseline to Day 56. The Cystic Fibrosis Respiratory Symptoms Daily Diary asks a participant to state the extent of their 8 respiratory symptoms : difficulty breathing, feverishness, tiredness, chills or sweats, coughing, coughing up mucus, tightness in the chest and wheezing. Each respiratory symptom is assigned a score from 0-4 based on the response, with zero corresponding to the absence of the symptom and four corresponding to symptom being present 'a great deal' or 'extremely'. A summed score (range from 0-24) is calculated for each participant and converted to a final score with a range of 0 to 100, where the lowest scores indicate improvement of symptoms. (NCT02354859)
Timeframe: Day 1 to Day 56

Interventionscore on a scale (Mean)
Gallium3.03
Placebo-0.98

[back to top]

Number of Participants With 5% or Greater Relative Change in FEV1 (Liters) From Baseline to Day 28

Difference between treatment groups in the proportion of subjects with 5% or greater relative change in FEV1 (liters) from baseline to Day 28. (NCT02354859)
Timeframe: Baseline to Day 28

InterventionParticipants (Count of Participants)
Gallium22
Placebo17

[back to top]

Relative Change in FEV1 (Liters) From Baseline to Day 56

Difference between treatment groups in the relative change in FEV1 (liters) from Baseline to Day 56 (NCT02354859)
Timeframe: Day 1 to Day 56

Interventionpercentage change (Mean)
Gallium1.89
Placebo-0.05

[back to top]

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Incidence is defined as the number and percentage of participants with at least one event over the 56 day follow-up period. (NCT02354859)
Timeframe: Day 1 to Day 56

,
InterventionParticipants (Count of Participants)
Incidence of AEsIncidence of SAEs
Gallium5711
Placebo579

[back to top]

Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Rate is defined as the number of events per participant follow-up week. (NCT02354859)
Timeframe: Day 1 to Day 56

,
Interventionevents per participant-week (Number)
Number of AEs per participant weekNumber of SAEs per participant week
Gallium0.840.02
Placebo1.030.03

[back to top]