pasireotide profile

pasireotide : A six-membered homodetic cyclic peptide composed from L-phenylglycyl, D-tryptophyl, L-lysyl, O-benzyl-L-tyrosyl, L-phenylalanyl and modified L-hydroxyproline residues joined in sequence. A somatostatin analogue with pharmacologic properties mimicking those of the natural hormone somatostatin; used (as its diaspartate salt) for treatment of Cushing's disease. [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]

ID Source	ID
PubMed CID	9941444
CHEMBL ID	3349607
CHEBI ID	72312
SCHEMBL ID	12462108
MeSH ID	M0507457

Synonym
gtpl2018
som 320
[(3s,6s,9s,12r,15s,18s,20r)-9-(4-aminobutyl)-12-(1h-indol-3-ylmethyl)-2,5,8,11,14,17-hexaoxo-15-phenyl-6-[[4-(phenylmethoxy)phenyl]methyl]-3-(phenylmethyl)-1,4,7,10,13,16-hexazabicyclo[16.3.0]henicosan-20-yl] n-(2-aminoethyl)carbamate
som-230
som 230
pasireotide
cyclo((4r)-4-(2-aminoethylcarbamoyloxy)-l-prolyl-l-phenylglycyl-d-tryptophyl-l-lysyl-4-o-benzyl-l-tyrosyl-l-phenylalanyl-)
pasireotide [usan:inn]
98h1t17066 ,
unii-98h1t17066
CHEBI:72312 ,
cyclo((4r)-4-(2-aminoethylcarbamoyloxy)-l-prolyl-l-phenylglycyl-d-tryptophyl-l-lysyl-4-o-benzyl-l-tyrosyl-l- phenylalanyl-)
pasireotida
pasireotidum
cyclo[(2s)-2-phenylglycyl-d-tryptophyl-l-lysyl-o-benzyl-l-tyrosyl-l-phenylalanyl-(4r)-4-{[(2-aminoethyl)carbamoyl]oxy}-l-prolyl]
SCHEMBL12462108
pasireotide [vandf]
pasireotide [mi]
pasireotide [who-dd]
DB06663
pasireotide [inn]
pasireotide [usan]
pasireotide [mart.]
HY-16381
CHEMBL3349607 ,
AKOS030526804
bdbm50474236
Q3896970
396091-73-9 (free base)
pasireotide free base
(3s,6r,9s,12s,15s,19r,20as)-6-((1h-indol-3-yl)methyl)-9-(4-aminobutyl)-15-benzyl-12-(4-(benzyloxy)benzyl)-1,4,7,10,13,16-hexaoxo-3-phenylicosahydropyrrolo[1,2-a][1,4,7,10,13,16]hexaazacyclooctadecin-19-yl (2-aminoethyl)carbamate
[(3s,6s,9s,12r,15s,18s,20r)-9-(4-aminobutyl)-3-benzyl-12-(1h-indol-3-ylmethyl)-2,5,8,11,14,17-hexaoxo-15-phenyl-6-[(4-phenylmethoxyphenyl)methyl]-1,4,7,10,13,16-hexazabicyclo[16.3.0]henicosan-20-yl] n-(2-aminoethyl)carbamate
NCGC00378682-03
(3s,6r,9s,12s,15s,19r,20as)-9-(4-aminobutyl)-15-benzyl-12-{[4-(benzyloxy)phenyl]methyl}-6-[(1h-indol-3-yl)methyl]-1,4,7,10,13,16-hexaoxo-3-phenyl-icosahydropyrrolo[1,2-a]1,4,7,10,13,16-hexaazacyclooctadecan-19-yl n-(2-aminoethyl)carbamate
EN300-23849528
h01cb05
pasireotide (mart.)
cyclo((2s)-2-phenylglycyl-d-tryptophyl-l-lysyl-o-benzyl-l-tyrosyl-l-phenylalanyl-(4r)-4-(((2-aminoethyl)carbamoyl)oxy)-l-prolyl)

Excerpt	Reference	Relevance
"Pasireotide is an effective and well-tolerated therapy in the treatment of refractory hypoglycemia in metastatic insulinoma."	( Pasireotide for Refractory Hypoglycemia in Malignant Insulinoma- Case Report and Review of the Literature. Chanez, B; Ewald, J; Maniry-Quellier, J; Niccoli, P; Oziel-Taieb, S; Poizat, F, 2022)	2.89
"Pasireotide (PAS) is a novel somatostatin receptor ligands (SRL), used in controlling hormonal hypersecretion in both acromegaly and Cushing's Disease (CD). "	( Pasireotide-Induced Shrinkage in GH and ACTH Secreting Pituitary Adenoma: A Systematic Review and Meta-Analysis. Barbot, M; Ceccato, F; Denaro, L; Ferrari, M; Manara, R; Mondin, A; Scaroni, C; Tizianel, I; Voltan, G, 2022)	3.61
"Pasireotide treatment is an alternative treatment in CD, remission is obtained in the first months of treatment, and continues for an extended period. "	( Pasireotide treatment in Cushing's disease: A single tertiary center's experience. Durcan, E; Kadıoğlu, P; Karimova, G; Özcan, ŞG; Özkaya, HM; Şahin, S, 2022)	3.61
"Pasireotide (PAS) is an effective treatment for Cushing's disease (CD) but its use is burdened by an associated high incidence of diabetes mellitus (DM). "	( Is pasireotide-induced diabetes mellitus predictable? A pilot study on the effect of a single dose of pasireotide on glucose homeostasis. Arnaldi, G; Barbot, M; Ceccato, F; Lizzul, L; Mondin, A; Plebani, M; Regazzo, D; Scaroni, C; Zaninotto, M; Zilio, M, 2020)	2.62
"Pasireotide LAR is an effective therapeutic option in patients with acromegaly refractory to first-generation SRLs. "	( The Effect of 6 Months' Treatment With Pasireotide LAR on Glucose Metabolism in Patients With Resistant Acromegaly in Real-World Clinical Settings. Bolanowski, M; Jawiarczyk-Przybyłowska, A; Kałużny, M; Szamotulska, K; Witek, P; Wojciechowska-Luźniak, A, 2021)	2.33
"Pasireotide is an effective treatment for acromegaly and Cushing's disease, although treatment-emergent hyperglycemia can occur. "	( Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study. Bolanowski, M; Feldt-Rasmussen, U; Gu, F; Jabbour, N; Kalra, P; Paul, M; Pedroncelli, AM; Pultar, P; Samson, SL; Witek, P; Yu, Y; Zhang, S, 2021)	2.48
"Pasireotide is a newer generation somatostatin analogue that led to a significant reduction in pancreatic fistula after pancreatectomy in a single-center randomized controlled trial. "	( Prospective Evaluation of Pasireotide in Patients Undergoing Pancreaticoduodenectomy: The Washington University Experience. Chapman, WC; Dominguez-Rosado, I; Doyle, MB; Fields, RC; Hammill, CW; Hawkins, WG; Horwedel, TA; Rose, JB; Sanford, DE; Strasberg, SM; Williams, G; Woolsey, CA, 2018)	2.22
"Pasireotide is a somatostatin analogue with an affinity for somatostatin receptors 1, 2, 3, and 5."	( Phase 1b study of pasireotide, everolimus, and selective internal radioembolization therapy for unresectable neuroendocrine tumors with hepatic metastases. Alese, OB; Brutcher, E; Chen, Z; El-Rayes, BF; Kim, HS; Nagaraju, GP; Renfroe, M; Shaib, WL; Wu, C; Zhang, C, 2018)	1.54
"Pasireotide (SOM230) is a multi-receptor ligand somatostatin analogue (SSA) developed as the successor of the first-generation SSAs. "	( Pasireotide - Mechanism of Action and Clinical Applications. Owecki, M; Ruchala, M; Sawicka-Gutaj, N, 2018)	3.37
"Pasireotide is a novel multireceptor-targeted somatostatin analog with high affinity for SSTR1, 2, 3, and 5."	( Pasireotide in the treatment of neuroendocrine tumors: a review of the literature. Colao, A; Di Molfetta, S; Dicitore, A; Faggiano, A; Rubino, M; Sciammarella, C; Vitale, G, 2018)	2.64
"Pasireotide is a new-generation somatostatin analog that acts through binding to multiple somatostatin receptor subtypes. "	( Pasireotide treatment does not modify hyperglycemic and corticosterone acute restraint stress responses in rats. Amaral, PHS; Bizzi, MF; Espirito-Santo, DTA; Ribeiro-Oliveira, A; Schmid, HA; Schweizer, JROL; Silveira, WCD; Soares, BS; Yuen, KCJ; Zille, G, 2018)	3.37
"Pasireotide is a second-generation somatostatin (SRIF) receptor ligand (SRL), approved for medical treatment of acromegaly and Cushing's disease (CD). "	( Cell specific interaction of pasireotide: review of preclinical studies in somatotroph and corticotroph pituitary cells. Amarù, J; Arvigo, M; Boschetti, M; Bruzzone, E; Campana, C; Cocchiara, F; Ferone, D; Gatto, F; Giusti, M; Graziani, G, 2019)	2.25
"Pasireotide is a sst multireceptor ligand with affinity for sst1, sst2, sst3 and sst5 and this broader binding profile may translate into a higher efficacy with respect to suppression of hormone production and cell growth in certain tumors."	( Pasireotide, a multi-somatostatin receptor ligand with potential efficacy for treatment of pituitary and neuroendocrine tumors. de Herder, WW; Feelders, RA; Hofland, LJ; Neggers, SJ; van der Lely, AJ, 2013)	2.55
"Pasireotide (Signifor(®)) is a new subcutaneous somatostatin analogue that acts via somatostatin receptors to inhibit the secretion of corticotropin from the pituitary adenoma in patients with Cushing's disease. "	( Pasireotide: a review of its use in Cushing's disease. McKeage, K, 2013)	3.28
"Pasireotide (SOM230) is a multireceptor-targeted somatostatin analog designed to have a broader somatostatin receptor binding profile than other currently available somatostatin analogs. "	( Assessment of the absorption, metabolism and excretion of [¹⁴C]pasireotide in healthy volunteers using accelerator mass spectrometry. Flarakos, J; He, H; Hu, K; Lin, TH; Mangold, JB; Sharr-McMahon, M; Wang, Y, 2013)	2.07
"Pasireotide (SOM230) is a somatostatin analog with affinity for somatostatin receptor subtypes sst₁₋₃ and sst₅. "	( Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. Armstrong, D; Burke, P; Ciaraldi, TP; Henry, RR; Ligueros-Saylan, M; Mudaliar, S, 2013)	2.12
"Pasireotide is a multi-receptor-targeted somatostatin analogue approved in the EU and in the US for the treatment of adults with Cushing's disease (CD). "	( Up-to 5-year efficacy of pasireotide in a patient with Cushing's disease and pre-existing diabetes: literature review and clinical practice considerations. Arnaldi, G; Boscaro, M; Cardinaletti, M; Concettoni, C; Marcelli, G; Trementino, L, 2015)	2.16
"Pasireotide is a multireceptor-targeted somatostatin analog effective in the treatment of Cushing's disease (CD). "	( The role of an acute pasireotide suppression test in predicting response to treatment in patients with Cushing's disease: findings from a pilot study. Arnaldi, G; Barbot, M; Boscaro, M; Ceccato, F; Marcelli, G; Michetti, G; Scaroni, C; Trementino, L; Zilio, M, 2015)	2.18
"Pasireotide LAR is a long-acting somatostatin analog that may inhibit meningioma growth. "	( Phase II study of monthly pasireotide LAR (SOM230C) for recurrent or progressive meningioma. Batchelor, TT; Beroukhim, R; Doherty, L; Drappatz, J; Gaffey, SC; Gerard, M; Haidar, S; Hammond, SN; Kaley, TJ; Lafrankie, D; Lee, EQ; Lesser, GJ; Ligon, KL; McCluskey, C; Muzikansky, A; Norden, AD; Phuphanich, S; Plotkin, SR; Raizer, JJ; Reardon, DA; Smith, KH; Wen, PY; Wong, ET, 2015)	2.16
"Pasireotide (SOM230) is a multireceptor-targeted somatostatin analogue with a 39-, 30- and 5-fold higher binding affinity for sstr5, sstr1 and sstr3, respectively, and a slightly lower (0.4-fold) affinity for sstr2 compared with octreotide."	( Pasireotide (SOM230) prevents sulfonylurea-induced hypoglycemia in rats. Schmid, HA, 2015)	2.58
"Pasireotide is a novel multireceptor ligand somatostatin analog that improves biochemical control of humans with HST."	( Pasireotide for the Medical Management of Feline Hypersomatotropism. Church, D; Forcada, Y; Gostelow, R; Niessen, SJ; Schmid, HA; Scudder, CJ, )	2.3
"Pasireotide (SOM230) is a somatostatin analog with high binding affinity for somatostatin receptors including sst1, 2, 3 and 5 and inhibit insulin like growth factor-1. "	( Phase I trial of combination of FOLFIRI and pasireotide, a somatostatin analogue, in advanced gastrointestinal malignancies. Almhanna, K; Fulp, W; Kim, R; Mahipal, A; Shibata, D; Siegel, E; Springett, G; Williams-Elson, I, 2015)	2.12
"Pasireotide is a multi-receptor targeted somatostatin-analog with improved affinity for SSTR5."	( Pasireotide for malignant insulinoma. Elnekave, E; Nir, K; Ravkin, Y; Saeger, W; Shimon, I; Solomonov, E; Stemmer, SM; Talmor, Y; Tirosh, A, 2016)	2.6
"Pasireotide LAR is a long-acting somatostatin multireceptor ligand."	( Pasireotide: a novel treatment for patients with acromegaly. Cuevas-Ramos, D; Fleseriu, M, 2016)	2.6
"Pasireotide LAR is a promising treatment option for patients with acromegaly inadequately controlled with the first-generation somatostatin analogue octreotide LAR."	( Switching patients with acromegaly from octreotide to pasireotide improves biochemical control: crossover extension to a randomized, double-blind, Phase III study. Bronstein, MD; Chen, Y; Colao, A; Farrall, AJ; Fleseriu, M; Freda, P; Gadelha, M; Gu, F; Hermosillo Reséndiz, K; Neggers, S; Ruffin, M; Shen, CC; Sheppard, M, 2016)	2.13
"Pasireotide is a new-generation, multireceptor-targeted somatostatin receptor ligand approved for CD (subcutaneous [SC] injection formulation) and acromegaly (long-acting release [LAR] formulation)."	( Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly. Silverstein, JM, 2016)	1.46
"Pasireotide is a novel multireceptor ligand somatostatin analogue, which has been demonstrated to reduce the incidence of PF following pancreas resection; however, the drug cost is significant."	( Pasireotide for the Prevention of Pancreatic Fistula Following Pancreaticoduodenectomy: A Cost-effectiveness Analysis. Behman, R; Coburn, NG; Eeson, G; Goyert, N; Hallet, J; Kagedan, DJ; Karanicolas, PJ; Law, C; Lemke, M; Mittmann, N, 2017)	2.62
"Pasireotide appears to be a cost-saving treatment following PD across a wide variation of clinical and cost scenarios."	( Pasireotide for the Prevention of Pancreatic Fistula Following Pancreaticoduodenectomy: A Cost-effectiveness Analysis. Behman, R; Coburn, NG; Eeson, G; Goyert, N; Hallet, J; Kagedan, DJ; Karanicolas, PJ; Law, C; Lemke, M; Mittmann, N, 2017)	3.34
"Pasireotide is a next-generation SRL with a broader pattern of interaction with sst."	( Somatostatin receptor ligands in the treatment of acromegaly. Bronstein, MD; Ferone, D; Gadelha, MR; Gatto, F; Wildemberg, LE, 2017)	1.18
"Pasireotide (SOM230) is a novel multireceptor ligand somatostatin analog with affinity for somatostatin receptor subtypes sst(1-3) and sst(5). "	( Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial. Abs, R; Barkan, A; Biller, BM; Buchelt, A; Colao, A; Farrall, AJ; Ho, YY; Hu, K; Melmed, S; Mohideen, P; Petersenn, S; Schopohl, J, 2010)	3.25
"Pasireotide is a promising treatment for acromegaly. "	( Pasireotide (SOM230) demonstrates efficacy and safety in patients with acromegaly: a randomized, multicenter, phase II trial. Abs, R; Barkan, A; Biller, BM; Buchelt, A; Colao, A; Farrall, AJ; Ho, YY; Hu, K; Melmed, S; Mohideen, P; Petersenn, S; Schopohl, J, 2010)	3.25
"Pasireotide is a novel multi-receptor-targeted somatostatin analogue with high affinity for sst(1,2,3) and sst(5)."	( Medical treatment of Cushing's disease: somatostatin analogues and pasireotide. Pedroncelli, AM, 2010)	1.32
"Pasireotide is a novel multireceptor-targeted somatostatin analogue that has shown efficacy in patients with acromegaly and Cushing's disease when administered by subcutaneous (SC) injection. "	( Pasireotide (SOM230), a novel multireceptor-targeted somatostatin analogue, is well tolerated when administered as a continuous 7-day subcutaneous infusion in healthy male volunteers. Bouillaud, E; Hu, K; Mann, K; Petersenn, S; Reséndiz, KH; Unger, N; Wang, Y; Weisshaar, B; Zhang, Y, 2012)	3.26
"Pasireotide (SOM230) is a multireceptor-targeted somatostatin analog with high binding affinity for sstr(1,2,3) and sstr(5). "	( Effects of somatostatin analogs on glucose homeostasis in rats. Brueggen, J; Schmid, HA, 2012)	1.82
"Pasireotide is a novel, multireceptor-targeted somatostatin analogue with high affinity for sst(1,2,3) and sst(5) under clinical evaluation in tumors of neuroendocrine origin, including Cushing's disease, acromegaly, and neuroendocrine tumors. "	( Effect of hepatic impairment on the pharmacokinetics of pasireotide (SOM230): results from a multicenter phase I study. Botha, FP; Bouillaud, E; Heuman, DM; Horsmans, Y; Hu, K; Mazur, D; Ruffin, M; Song, D; Wang, Y, 2012)	2.07
"Pasireotide (SOM230) is a multireceptor-targeted somatostatin analog with high binding affinity for four of the five somatostatin receptor subtypes (sst(1,2,3) and sst(5)), and potential clinical activity in several neuroendocrine and oncologic conditions, including acromegaly, Cushing's disease, and neuroendocrine tumors (NET). "	( A first-in-man study to evaluate the safety, tolerability, and pharmacokinetics of pasireotide (SOM230), a multireceptor-targeted somatostatin analog, in healthy volunteers. Bouillaud, E; Buchelt, A; Golor, G; Hu, K; Maldonado, M; Ruffin, M; Wang, Y, 2012)	2.05
"Pasireotide is a multireceptor-targeted somatostatin analogue that has high affinity for 4 of the 5 somatostatin receptor subtypes (sst1,2,3 and sst5) and has therapeutic potential in conditions with tumors of neuroendocrine origin, such as Cushing disease, acromegaly, and neuroendocrine tumors. "	( An open-label dose-escalation study of once-daily and twice-daily pasireotide in healthy volunteers: safety, tolerability, and effects on glucose, insulin, and glucagon levels. Bouillaud, E; Hu, K; Hudson, M; Maldonado, M; Nesheiwat, D; Shenouda, M; Wang, Y, )	1.81
"Pasireotide is a somatostatin analog with binding affinity to a broader range of somatostatin receptor subtypes than octreotide."	( Phase I study of pasireotide (SOM 230) and everolimus (RAD001) in advanced neuroendocrine tumors. Abrams, TA; Chan, JA; Fuchs, CS; Kulke, MH; Malinowski, P; Regan, EM; Ryan, DP; Wolpin, BM; Zhu, AX, 2012)	1.44
"Pasireotide (SOM230) is a novel multireceptor-targeted somatostatin (sst) analog with high binding affinity for sst receptor subtype 1, 2, 3 (sst(1,2,3)) and sst(5). "	( Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a phase II study. Anthony, L; Arnold, R; de Herder, WW; Hu, K; Hughes, G; Kvols, LK; Mohideen, P; O'Dorisio, TM; Oberg, KE; Wiedenmann, B; Zhang, Y, 2012)	3.26
"Pasireotide is a multireceptor-targeted somatostatin analogue and is the only approved medical therapy for Cushing's disease that treats the underlying cause of the disorder."	( Pituitary-directed medical therapy with pasireotide for a corticotroph macroadenoma: pituitary volume reduction and literature review. Inbar, E; Rot, L; Shimon, I, 2012)	1.37
"Pasireotide (SOM230) is a multi-receptor ligand somatostatin analogue with high binding affinity for somatostatin receptor subtypes sst(1,2,3) and sst(5). "	( Pasireotide (SOM230): development, mechanism of action and potential applications. Schmid, HA, 2008)	3.23
"Pasireotide (SOM-230) is a small somatostatin (SST) analog that is being developed by Novartis Pharma AG for the potential treatment of acromegaly, Cushing's disease and neuroendocrine tumors; the compound is currently in phase III clinical trials for Cushing's disease. "	( Pasireotide--a somatostatin analog for the potential treatment of acromegaly, neuroendocrine tumors and Cushing's disease. Ben-Shlomo, A; Melmed, S, 2007)	3.23

Excerpt	Reference	Relevance
"Pasireotide, which has a high affinity for somatostatin receptor (SSTR) 5, has attracted attention as a new treatment for refractory Cushing's disease. "	( Pasireotide-resistant Refractory Cushing's Disease without Somatostatin Receptor 5 Expression. Fukuhara, N; Inoshita, N; Mizuno, T; Nishioka, H; Takeshita, A; Takeuchi, Y; Tatsushima, K; Yamada, S, 2022)	3.61
"Pasireotide has a high affinity for SSTR5, indicating that these tumours may be more sensitive to treatment."	( Improved pasireotide response in USP8 mutant corticotroph tumours in vitro. Albani, A; Buchfelder, M; Colón-Bolea, P; Flitsch, J; Herms, J; Lucia, KE; Perez-Rivas, LG; Reincke, M; Roeber, S; Rotermund, R; Schopohl, J; Simon, J; Stalla, G; Tang, S; Theodoropoulou, M; Thorsteinsdottir, J, 2022)	1.86
"Pasireotide has a high affinity for SSTR2 and SSTR5, and the addition of SSTR2- and SSTR5-specific antagonists leads to a loss of protection."	( Pasireotide protects mammalian cochlear hair cells from gentamicin ototoxicity by activating the PI3K-Akt pathway. Bodmer, D; Horvath, L; Kucharava, K; Petkovic, V; Sekulic-Jablanovic, M, 2019)	2.68
"Pasireotide has a broader somatostatin receptor binding profile than other somatostatin analogues. "	( Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-ended, multicenter, Phase II extension study. Barkan, A; Block, C; Caron, P; Colao, A; Cuneo, R; De Block, C; Farrall, AJ; Hermosillo Reséndiz, K; Hu, K; Hughes, G; Kleinberg, D; Melmed, S; Petersenn, S; Ruffin, M; Schopohl, J, 2014)	2.1
"Pasireotide has a receptor binding profile that is distinct from that of other somatostatin analogues, binding with high affinity to somatostatin receptor subtype 5, which is strongly over expressed in corticotroph adenoma cells."	( Pasireotide: a review of its use in Cushing's disease. McKeage, K, 2013)	2.55
"Pasireotide has a safety profile similar to other somatostatin analogues with the exception of hyperglycemia."	( Up-to 5-year efficacy of pasireotide in a patient with Cushing's disease and pre-existing diabetes: literature review and clinical practice considerations. Arnaldi, G; Boscaro, M; Cardinaletti, M; Concettoni, C; Marcelli, G; Trementino, L, 2015)	1.44
"Pasireotide has a unique binding profile, with high affinity for four of the five somatostatin receptors, especially SSTR(5), the receptor most prevalent in corticotroph tumors."	( Pasireotide for the treatment of Cushing's disease. Arnaldi, G; Boscaro, M, 2010)	2.52
"Pasireotide has been positioned mostly as a compound to be used in first-generation SRLs resistant patients and after surgical failure, but sufficient data are now available to indicate it is a first line therapy for patients with certain characteristics."	( Pasireotide in the Personalized Treatment of Acromegaly. Aller, J; Alvarez-Escolá, C; Bernabéu, I; Biagetti, B; Cámara, R; Gálvez, MA; Gil, J; Jordà, M; Lamas, C; Marazuela, M; Marques-Pamies, M; Picó, A; Puig-Domingo, M; Soldevila, B, 2021)	2.79
"Pasireotide has been associated with tumor shrinkage in patients with Cushing's disease subjected to long term treatment. "	( Somatostatin analogs regulate tumor corticotrophs growth by reducing ERK1/2 activity. Arosio, M; Catalano, R; Giardino, E; Locatelli, M; Mangili, F; Mantovani, G; Peverelli, E; Sala, E; Spada, A; Treppiedi, D; Vercesi, P, 2019)	1.96
"Pasireotide LAR has been shown to be more effective than other SRLs in providing biochemical control in patients with acromegaly."	( Management of Hyperglycemia in Patients With Acromegaly Treated With Pasireotide LAR. Samson, SL, 2016)	1.39

Excerpt	Reference	Relevance
"Pasireotide was able to activate sst(3) and sst(5) receptors but was only a partial agonist at the sst(2) receptor."	( A transplantable phosphorylation probe for direct assessment of G protein-coupled receptor activation. Kliewer, A; Mann, A; Petrich, A; Pöll, F; Schulz, S, 2012)	1.1

Excerpt	Reference	Relevance
"Pasireotide treatment is an alternative treatment in CD, remission is obtained in the first months of treatment, and continues for an extended period. "	( Pasireotide treatment in Cushing's disease: A single tertiary center's experience. Durcan, E; Kadıoğlu, P; Karimova, G; Özcan, ŞG; Özkaya, HM; Şahin, S, 2022)	3.61
"Pasireotide treatment resulted in significant decreases in insulin AUC0-180 min during both the hyperglycemic clamp test (-77.5%; P < .001 in both dose groups) and the OGTT (-61.9%; P < .001 in both dose groups). "	( Hyperglycemia associated with pasireotide: results from a mechanistic study in healthy volunteers. Armstrong, D; Burke, P; Ciaraldi, TP; Henry, RR; Ligueros-Saylan, M; Mudaliar, S, 2013)	2.12
"Pasireotide was the only treatment to be assessed in a randomized trial and was supported by a 'moderate' level of evidence."	( Efficacy of medical treatment in Cushing's disease: a systematic review. Gadelha, MR; Vieira Neto, L, 2014)	1.12
"Pasireotide treatment can result in a meaningful HRQOL improvement among those who complete a 12-month treatment period, most often among patients achieving biochemical control."	( Treatment effectiveness of pasireotide on health-related quality of life in patients with Cushing's disease. Badia, X; de Block, C; Forsythe, A; Gadelha, M; Maldonado, M; McLeod, L; Nelson, LM; Portocarrero-Ortiz, L; Signorovitch, JE; Ware, JE; Webb, SM; Yang, M; Zgliczynski, W, 2014)	2.14
"Pasireotide treatment was associated with a normalization of 24-h urinary-free cortisol at last follow-up in about 68 % of patients."	( The role of an acute pasireotide suppression test in predicting response to treatment in patients with Cushing's disease: findings from a pilot study. Arnaldi, G; Barbot, M; Boscaro, M; Ceccato, F; Marcelli, G; Michetti, G; Scaroni, C; Trementino, L; Zilio, M, 2015)	1.46
"Pasireotide treatment induced full disease control in 37.5 % and partial disease control in 37.5 % after 6 months, whereas full and partial disease control after 12 months was obtained in 28.6 % and in 57.1 % of patients, respectively."	( The treatment with pasireotide in Cushing's disease: effects of long-term treatment on tumor mass in the experience of a single center. Auriemma, RS; Cirillo, S; Colao, A; Cozzolino, A; De Leo, M; De Martino, MC; Iacuaniello, D; Mainolfi, CG; Pivonello, C; Pivonello, R; Rossi, R; Simeoli, C; Tortora, F, 2015)	1.47
"Pasireotide-treated Men1(+/-) mice had increased survival (pasireotide, 80.9% vs PBS, 65.2%; P < .05), with fewer mice developing pancreatic NETs (pasireotide, 86.9% vs PBS, 96.9%; P < .05) and smaller increases in pituitary NET volumes (pre-treated vs post-treated, 0.803 ± 0.058 mm(3) vs 2.872 ± 0.728 mm(3) [pasireotide] compared with 0.844 ± 0.066 mm(3) vs 8.847 ±1.948 mm(3) [PBS]; P < .01)."	( Pasireotide Therapy of Multiple Endocrine Neoplasia Type 1-Associated Neuroendocrine Tumors in Female Mice Deleted for an Men1 Allele Improves Survival and Reduces Tumor Progression. Grossman, AB; Lines, KE; Schmid, HA; Soukup, BS; Stevenson, M; Thakker, RV; Walls, GV, 2016)	2.6
"Pasireotide treatment was associated with sustained biochemical and clinical benefit in about 60% of CD patients."	( A Single-Center 10-Year Experience with Pasireotide in Cushing's Disease: Patients' Characteristics and Outcome. Angeletti, A; Arnaldi, G; Boscaro, M; Cardinaletti, C; Concettoni, C; Marcelli, G; Michetti, G; Polenta, B; Trementino, L, 2016)	1.42
"Co-treatment with pasireotide, a somatostatin analog that blocks GH secretion and IGF-I action in the mammary gland, prevented hormone-induced hyperplasia."	( Pasireotide, an IGF-I action inhibitor, prevents growth hormone and estradiol-induced mammary hyperplasia. Ameri, P; Kleinberg, DL; Singh, B, 2011)	2.14

Excerpt	Reference	Relevance
" Assessments included adverse events (AEs), PKs, and glucose, insulin, glucagon, and HbA1c levels."	( Safety, tolerability, and pharmacokinetics of a single dose of pasireotide long-acting release in healthy volunteers: a single-center Phase I study. Bouillaud, E; Dietrich, H; Hasskarl, J; Hu, K; Ruffin, M; Song, D; Wang, Y, 2012)	0.62
" Pasireotide was well tolerated with no serious adverse events observed at any dose."	( A first-in-man study to evaluate the safety, tolerability, and pharmacokinetics of pasireotide (SOM230), a multireceptor-targeted somatostatin analog, in healthy volunteers. Bouillaud, E; Buchelt, A; Golor, G; Hu, K; Maldonado, M; Ruffin, M; Wang, Y, 2012)	1.51
" Pasireotide was generally well tolerated at all doses; adverse events were predominantly mild-to-moderate gastrointestinal disorders."	( An open-label dose-escalation study of once-daily and twice-daily pasireotide in healthy volunteers: safety, tolerability, and effects on glucose, insulin, and glucagon levels. Bouillaud, E; Hu, K; Hudson, M; Maldonado, M; Nesheiwat, D; Shenouda, M; Wang, Y, )	1.28
" The most common adverse events were transient gastrointestinal disturbances; hyperglycemia-related events occurred in 14 patients."	( Long-term efficacy and safety of subcutaneous pasireotide in acromegaly: results from an open-ended, multicenter, Phase II extension study. Barkan, A; Block, C; Caron, P; Colao, A; Cuneo, R; De Block, C; Farrall, AJ; Hermosillo Reséndiz, K; Hu, K; Hughes, G; Kleinberg, D; Melmed, S; Petersenn, S; Ruffin, M; Schopohl, J, 2014)	0.66
" Adverse events were reported by 34 (81 %) patients, with the most frequently reported including diarrhea, fatigue, abdominal pain, and nausea."	( Safety, tolerability, pharmacokinetics, and pharmacodynamics of a long-acting release (LAR) formulation of pasireotide (SOM230) in patients with gastroenteropancreatic neuroendocrine tumors: results from a randomized, multicenter, open-label, phase I stud Bouillaud, E; Giannone, V; Hu, K; Hughes, G; Resendiz, KH; Wolin, EM, 2013)	0.6
" Adverse events were mostly gastrointestinal and mild/moderate."	( Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study. Arafat, AM; Beckers, A; Bollerslev, J; Giannone, V; Hu, K; Hughes, G; Katznelson, L; Lasher, J; Petersenn, S; Reséndiz, KH; Schopohl, J; Serri, O; Shen, G, 2014)	0.66
"Of the 45 randomized HVs, 42 completed the study per protocol, 1 withdrew his informed consent for personal reasons, and 2 prematurely discontinued the study because of adverse events (AEs)."	( Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: a phase I, single-center, open-label, randomized study. Chen, X; Darstein, C; Hu, K; Hu, P; Jiang, J; Lasher, J; Liu, H; Shen, G, 2014)	0.66
"The most commonly reported adverse events include injection-site discomfort and erythema, gastrointestinal (GI) disturbances such as diarrhea, abdominal pain, nausea and vomiting, biliary sludge or gallstones, and abnormal glucose metabolism."	( Adverse events associated with somatostatin analogs in acromegaly. Auriemma, RS; Colao, A; Grasso, LF; Pivonello, R, 2015)	0.42
" The primary outcome was the proportion of patients having a treatment-emergent grade ≥3 or serious adverse event."	( Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study. Fleseriu, M; Geer, EB; Rusch, E, 2017)	0.75
" Twenty-five grade ≥3 treatment-emergent adverse events were reported in 11 patients (25."	( Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study. Fleseriu, M; Geer, EB; Rusch, E, 2017)	0.75
"Grade ≥3 adverse events (primary outcome) were reported in 25."	( Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study. Fleseriu, M; Geer, EB; Rusch, E, 2017)	0.75
" Twenty-nine patients completed the 12-month core phase, 1 withdrew consent, and 3 discontinued treatment due to adverse events (AEs; diabetes mellitus, hyperglycemia, liver function abnormality, n=1 each)."	( Efficacy and safety of long-acting pasireotide in Japanese patients with acromegaly or pituitary gigantism: results from a multicenter, open-label, randomized, phase 2 study. Kaneko, T; Murakami, M; Shimatsu, A; Tahara, S, 2017)	0.73
" The most common adverse events were hyperglycaemia (36 [49%] in the 10 mg group and 36 [47%] in the 30 mg group), diarrhoea (26 [35%] and 33 [43%]), cholelithiasis (15 [20%] and 34 [45%]), diabetes mellitus (14 [19%] and 18 [24%]), and nausea (15 [20%] and 16 [21%])."	( Efficacy and safety of once-monthly pasireotide in Cushing's disease: a 12 month clinical trial. Biller, BMK; Boscaro, M; Gallardo, W; Gu, F; Lacroix, A; Newell-Price, J; Petersenn, S; Pivonello, R; Ravichandran, S; Roughton, M; Salvatori, R; Tauchmanova, L; Witek, P; Yamada, M; Yu, Y, 2018)	0.76
" The most common grade 1-2 adverse events with a suspected association with long-acting pasireotide monotherapy were diarrhoea (15 [37%] of 41), hyperglycaemia (17 [41%]), and weight loss (8 [20%]); those with a suspected association with everolimus monotherapy were stomatitis (26 [62%] of 42) and diarrhoea (16 [38%]); and those suspected to be associated with combination treatment were hyperglycaemia (27 [66%] of 41]), diarrhoea (19 [46%]), and asthenia (8 [20%])."	( Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial. Baudin, E; Berruti, A; Brizzi, MP; Buikhuisen, W; Damiano, V; De Castro, J; Do Cao, C; Ferolla, P; Gislimberti, G; Grohé, C; Grønbæk, H; Léna, H; Lombard-Bohas, C; Mansoor, W; Mazieres, J; Meyer, T; Minotti, V; Öberg, K; Reed, N; Singh, N; Stankovic, M; Tiseo, M, 2017)	0.95
" PAS-LAR was well tolerated, but hyperglycemia was the most frequent adverse event."	( Efficacy and Safety of Switching to Pasireotide in Patients With Acromegaly Controlled With Pegvisomant and First-Generation Somatostatin Analogues (PAPE Study). Dallenga, AHG; Delhanty, PJD; Haitsma, IK; Janssen, JAMJL; Muhammad, A; Neggers, SJCMM; van der Lely, AJ, 2018)	0.76
" Overall (month 0-12), the most frequent (>20% of patients) adverse events were headache (34."	( Safety and efficacy of pasireotide in dumping syndrome-results from a phase 2, multicentre study. Aberle, J; Arts, J; Bender, G; Bhoyrul, S; Laville, M; McLaughlin, T; O'Connell, P; Oppert, JM; Passos, VQ; Tack, J; Van Beek, AP; Vella, A; Yoshikawa, T; Zhou, J, 2018)	0.79
" In addition, the current study focused on safety issues encountered during the study, detailing the management of the different adverse events associated with the treatment with pasireotide in Naples center."	( The treatment with pasireotide in Cushing's disease: effect of long-term treatment on clinical picture and metabolic profile and management of adverse events in the experience of a single center. Angellotti, D; Colao, A; De Martino, MC; Ferrigno, R; Iacuaniello, D; Negri, M; Papa, F; Patalano, R; Pivonello, C; Pivonello, R; Simeoli, C, 2020)	1.08
" Deterioration of glucose metabolism represented the most common adverse event, occurring in 71."	( The treatment with pasireotide in Cushing's disease: effect of long-term treatment on clinical picture and metabolic profile and management of adverse events in the experience of a single center. Angellotti, D; Colao, A; De Martino, MC; Ferrigno, R; Iacuaniello, D; Negri, M; Papa, F; Patalano, R; Pivonello, C; Pivonello, R; Simeoli, C, 2020)	0.89
" Among 31 new-use and 92 prior-use patients with ≥ 1 safety assessment, respectively: 24 (77%) and 37 (40%) had drug-related adverse events (AEs); 7 (23%) and 10 (11%) had serious drug-related AEs."	( Long-term safety and efficacy of subcutaneous pasireotide in patients with Cushing's disease: interim results from a long-term real-world evidence study. Deutschbein, T; Giordano, C; Kriemler-Krahn, U; Maamari, R; Manetti, L; Roughton, M; Schopohl, J; Tauchmanova, L; Yuen, KCJ, 2019)	0.77
" This single center, longitudinal retrospective study evaluated the incidence and the predictors of biliary adverse events (BAE) in acromegaly during SRL therapy and their response to ursodeoxycholic acid (UDCA)."	( Biliary adverse events in acromegaly during somatostatin receptor ligands: predictors of onset and response to ursodeoxycholic acid treatment. Berton, AM; Bona, C; Cuboni, D; Fenoglio, LM; Gasco, V; Ghigo, E; Grottoli, S; Parasiliti-Caprino, M; Prencipe, N, 2021)	0.62
"Biliary stone disease is a frequent SRL adverse event, although it is often symptomless."	( Biliary adverse events in acromegaly during somatostatin receptor ligands: predictors of onset and response to ursodeoxycholic acid treatment. Berton, AM; Bona, C; Cuboni, D; Fenoglio, LM; Gasco, V; Ghigo, E; Grottoli, S; Parasiliti-Caprino, M; Prencipe, N, 2021)	0.62
" All adverse events that occurred in participants throughout the study period, including abnormalities in fasting levels of glucose, insulin, and glucagon, as well as laboratory measurements and electrocardiograms, were recorded."	( Pharmacokinetics and Safety of Long-Acting Release Formulations of Pasireotide (SOM230) in a Male Population Who Are Hyperendemic Hepatitis B/C and Chronic Kidney Disease: An Open-Label, Phase I Study. Huang, CJ; Lu, CH; Shih, KC, 2023)	1.15
"8%) were the most frequent adverse events."	( Long-term efficacy and safety of subcutaneous pasireotide alone or in combination with cabergoline in Cushing's disease. Bex, M; Biller, BMK; Boguszewski, CL; Chattopadhyay, A; Feelders, RA; Fleseriu, M; González-Devia, D; Kadioglu, P; Maamari, R; Patino, H; Pedroncelli, AM; Pivonello, R; Yavuz, DG, 2023)	1.17

Excerpt	Reference	Relevance
" SOM230, a novel somatostatin analog, was compared with octreotide with respect to pharmacokinetic (PK) profiles and inhibition of GH secretion in acromegalic patients."	( Pharmacokinetic-pharmacodynamic comparison of a novel multiligand somatostatin analog, SOM230, with octreotide in patients with acromegaly. Lamberts, SW; Ma, P; Nedelman, J; Schran, H; Tran, LL; van der Hoek, J; Wang, Y, 2005)	0.33
" The elimination half-life for SOM230 is about 5 times longer than that for octreotide (11."	( Pharmacokinetic-pharmacodynamic comparison of a novel multiligand somatostatin analog, SOM230, with octreotide in patients with acromegaly. Lamberts, SW; Ma, P; Nedelman, J; Schran, H; Tran, LL; van der Hoek, J; Wang, Y, 2005)	0.33
"SOM230 demonstrates a lower clearance and longer half-life than octreotide, which compensates for the lower potency in GH inhibition."	( Pharmacokinetic-pharmacodynamic comparison of a novel multiligand somatostatin analog, SOM230, with octreotide in patients with acromegaly. Lamberts, SW; Ma, P; Nedelman, J; Schran, H; Tran, LL; van der Hoek, J; Wang, Y, 2005)	0.33
"To evaluate the safety profile, tolerability, and pharmacokinetic profile of pasireotide in single- and divided-dose regimens in healthy volunteers."	( Tolerability and dose proportional pharmacokinetics of pasireotide administered as a single dose or two divided doses in healthy male volunteers: a single-center, open-label, ascending-dose study. Bouillaud, E; Hu, K; Lasher, J; Maldonado, M; Mann, K; Petersenn, S; Unger, N; Wang, Y; Zhang, Y, 2012)	0.86
" Mean total body clearance was 8 to 9 L/h across the dosage groups and dosing regimens, indicating a linear pharmacokinetic profile between doses."	( Tolerability and dose proportional pharmacokinetics of pasireotide administered as a single dose or two divided doses in healthy male volunteers: a single-center, open-label, ascending-dose study. Bouillaud, E; Hu, K; Lasher, J; Maldonado, M; Mann, K; Petersenn, S; Unger, N; Wang, Y; Zhang, Y, 2012)	0.63
" Its pharmacokinetic profile indicated rapid absorption, low clearance, high volume of distribution, and a long terminal half-life."	( Tolerability and dose proportional pharmacokinetics of pasireotide administered as a single dose or two divided doses in healthy male volunteers: a single-center, open-label, ascending-dose study. Bouillaud, E; Hu, K; Lasher, J; Maldonado, M; Mann, K; Petersenn, S; Unger, N; Wang, Y; Zhang, Y, 2012)	0.63
"5 hours), low clearance (CL/F: 8-13 L/hour), long effective elimination half-life (mean t(½,β): 7-11 hours), and a proportional dose-exposure relationship."	( A first-in-man study to evaluate the safety, tolerability, and pharmacokinetics of pasireotide (SOM230), a multireceptor-targeted somatostatin analog, in healthy volunteers. Bouillaud, E; Buchelt, A; Golor, G; Hu, K; Maldonado, M; Ruffin, M; Wang, Y, 2012)	0.6
" Pharmacokinetic sampling for pasireotide SC and verapamil was done during days 18 to 25 and days 15 to 21, respectively."	( Effect of verapamil on the pharmacokinetics of pasireotide in healthy volunteers. Hu, K; Kornberger, R; Nesheiwat, D; Passos, VQ; Rodrigues, H; Ting, LS; Tripathi, AP, 2014)	0.95
"The purpose of this study was to assess the pharmacokinetic (PK) properties and safety of single and multiple doses of subcutaneous (SC) pasireotide and a single-dose intramuscular (IM) long-acting release (LAR) formulation of pasireotide in Chinese healthy volunteers (HVs) versus the PK properties in Western HVs (pooled from previous PK studies)."	( Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: a phase I, single-center, open-label, randomized study. Chen, X; Darstein, C; Hu, K; Hu, P; Jiang, J; Lasher, J; Liu, H; Shen, G, 2014)	0.87
" After considering age and weight as covariates in the statistical model, the GMRs and 90% CIs for other PK parameters were within the predefined interval (Cmax in single-dose SC administration) or significantly decreased (Cmin,ss in multiple BID SC doses and first peak Cmax in the single-dose LAR formulation)."	( Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: a phase I, single-center, open-label, randomized study. Chen, X; Darstein, C; Hu, K; Hu, P; Jiang, J; Lasher, J; Liu, H; Shen, G, 2014)	0.66
" A three-compartment, linear structural pharmacokinetic model was used."	( Population Pharmacokinetics of Subcutaneous Pasireotide in Healthy Volunteers and Cushing's Disease Patients. Fisch, R; Hu, K; Nedelman, J; Paule, I; Zhou, J, 2018)	0.74
" Therefore, this open-label, phase I study aimed to evaluate the pharmacokinetic profiles and safety of subcutaneous (SC) and long-acting release (LAR) intramuscular injections of pasireotide in male Taiwanese volunteers who are hyperendemic hepatitis B/C and chronic kidney disease (CKD)."	( Pharmacokinetics and Safety of Long-Acting Release Formulations of Pasireotide (SOM230) in a Male Population Who Are Hyperendemic Hepatitis B/C and Chronic Kidney Disease: An Open-Label, Phase I Study. Huang, CJ; Lu, CH; Shih, KC, 2023)	1.34
" Pharmacokinetic parameters were assessed from both formulations."	( Pharmacokinetics and Safety of Long-Acting Release Formulations of Pasireotide (SOM230) in a Male Population Who Are Hyperendemic Hepatitis B/C and Chronic Kidney Disease: An Open-Label, Phase I Study. Huang, CJ; Lu, CH; Shih, KC, 2023)	1.15

Excerpt	Reference	Relevance
"A new non-cytotoxic therapy that SOM230 (pasireotide)，a somatostatin analogue (SSTA) combined with celecoxib, a selective cyclooxygenase-2 (COX-2) inhibitor was tested in nude mice bearing HepG2 xenografts."	( SOM230 combined with celecoxib prolongs the survival in nude mice with HepG-2 xenografts. Chen, S; Tang, CW; Wang, CH; Xie, Y, 2011)	0.64
" This trial will evaluate the effect of aspiration sclerotherapy combined with the somatostatin analogue pasireotide on cyst reduction."	( Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial. Drenth, JP; Gevers, TJ; Kool, LJ; Wijnands, TF, 2015)	0.9
"This single center, randomized, double-blind, placebo-controlled clinical trial evaluates the additional effect of pasireotide when combined with aspiration sclerotherapy in patients with a large (>5 cm) symptomatic hepatic cyst."	( Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial. Drenth, JP; Gevers, TJ; Kool, LJ; Wijnands, TF, 2015)	0.9
" The validated method was successfully implemented to support a toxicity study in monkeys administered with 5 and 30mg of SOM230 in a single intramuscular injection of a long acting release (LAR) formulation."	( Quantitative analysis of pasireotide (SOM230), a cyclic peptide, in monkey plasma using liquid chromatography in combination with tandem mass spectrometry. Flarakos, J; Fu, Y; Li, W; Tse, FLS, 2016)	0.74
" In this study, we aim at determining the antitumor efficacy of everolimus alone or in combination with the SSAs octreotide and pasireotide in primary cultures of pNETs."	( Anti-proliferative and anti-secretory effects of everolimus on human pancreatic neuroendocrine tumors primary cultures: is there any benefit from combination with somatostatin analogs? Albertelli, M; Barbieri, F; Barlier, A; Brue, T; Delpero, JR; Ferone, D; Florio, T; Garcia, S; Gerard, C; Mohamed, A; Moutardier, V; Niccoli, P; Poizat, F; Roche, C; Romano, D; Saveanu, A, 2017)	0.66
" Aim of this study was to evaluate pasireotide alone and in combination with everolimus in patients with MTC."	( The antiproliferative effect of pasireotide LAR alone and in combination with everolimus in patients with medullary thyroid cancer: a single-center, open-label, phase II, proof-of-concept study. Aria, M; Camera, L; Chiofalo, MG; Colao, A; Del Prete, M; Faggiano, A; Ferolla, P; Fonti, R; Modica, R; Pezzullo, L; Severino, R; Vitale, G, 2018)	1.04
"This study evaluated short- and long-term efficacy and safety of the second-generation somatostatin receptor ligand pasireotide alone or in combination with dopamine agonist cabergoline in patients with Cushing's disease (CD)."	( Long-term efficacy and safety of subcutaneous pasireotide alone or in combination with cabergoline in Cushing's disease. Bex, M; Biller, BMK; Boguszewski, CL; Chattopadhyay, A; Feelders, RA; Fleseriu, M; González-Devia, D; Kadioglu, P; Maamari, R; Patino, H; Pedroncelli, AM; Pivonello, R; Yavuz, DG, 2023)	1.38

Excerpt	Relevance	Reference
" Concentrations of SOM230, octreotide, and GH were determined at designated times after dosing and at baseline."	( Pharmacokinetic-pharmacodynamic comparison of a novel multiligand somatostatin analog, SOM230, with octreotide in patients with acromegaly. Lamberts, SW; Ma, P; Nedelman, J; Schran, H; Tran, LL; van der Hoek, J; Wang, Y, 2005)	0.33
" As a result of the lower interpatient variability for EC50 , SOM230 is expected to have a more uniform clinical GH inhibition than octreotide for acromegalic patients at a clinically effective dosing regimen."	( Pharmacokinetic-pharmacodynamic comparison of a novel multiligand somatostatin analog, SOM230, with octreotide in patients with acromegaly. Lamberts, SW; Ma, P; Nedelman, J; Schran, H; Tran, LL; van der Hoek, J; Wang, Y, 2005)	0.33
" Mean total body clearance was 8 to 9 L/h across the dosage groups and dosing regimens, indicating a linear pharmacokinetic profile between doses."	( Tolerability and dose proportional pharmacokinetics of pasireotide administered as a single dose or two divided doses in healthy male volunteers: a single-center, open-label, ascending-dose study. Bouillaud, E; Hu, K; Lasher, J; Maldonado, M; Mann, K; Petersenn, S; Unger, N; Wang, Y; Zhang, Y, 2012)	0.63
" PK steady state appeared to be achieved after 3 days of dosing and PK exposures had a moderate accumulation of 20-40 % across doses."	( Multiple once-daily subcutaneous doses of pasireotide were well tolerated in healthy male volunteers: a randomized, double-blind, placebo-controlled, cross-over, Phase I study. Beglinger, C; Bouillaud, E; Darstein, C; Hu, K; Mohideen, P; Wang, Y, 2012)	0.64
" Dose-response studies with 1 nM-1 μM SOM230 were performed on rat adrenals."	( Stimulatory effect of SOM230 on human and rat adrenal corticosteroid secretion in vitro. Cassarino, MF; Castelli, L; Cavagnini, F; Martucci, F; Montanari, E; Pagliardini, L; Pecori Giraldi, F; Schmid, HA; Sesta, A, 2012)	0.38
" In contrast, acute and chronic pasireotide dosing increased random and post-intraperitoneal glucose tolerance test blood glucose measures, compared to vehicle-treated controls."	( Effect of AP102, a subtype 2 and 5 specific somatostatin analog, on glucose metabolism in rats. Boyle, CN; Daly, AF; Eugster, PJ; Grouzmann, E; Harris, AG; Lutz, TA; Pfundstein, S; Seebeck, P; Tarasco, E, 2017)	0.74
" Continuous administration of everolimus at a low dose as opposed to high intermittent dosing schedule has greater antitumor efficacy against thyroid cancer xenografts in vivo."	( Evaluation of preclinical efficacy of everolimus and pasireotide in thyroid cancer cell lines and xenograft models. Chen, Z; Khuri, FR; Lallani, SB; Lonial, S; Marcus, A; Martinson, DE; Owonikoko, TK; Sun, SY; Zhang, G, 2019)	0.76
"Of 88 enrolled subjects, 52 and 82 participated in sc and LAR dosing phases, respectively."	( Combination of pasireotide and octreotide: effects on GH and IGF-I secretion and glucose metabolism in healthy volunteers. Breitschaft, A; Choudhury, S; Darstein, C; Drutinus, E; Gericke, G; Han, KT; Holder, G; Paul, M; Pedroncelli, AM; Schmid, HA; Tauchmanova, L, 2022)	1.07
"A total of 45 male volunteers were randomized to receive one of nine treatment sequences, involving a single subcutaneous injection of 300, 600, or 900 μg pasireotide, a multiple SC injection of the same dosage of pasireotide [300, 600, or 900 μg, twice daily (b."	( Pharmacokinetics and Safety of Long-Acting Release Formulations of Pasireotide (SOM230) in a Male Population Who Are Hyperendemic Hepatitis B/C and Chronic Kidney Disease: An Open-Label, Phase I Study. Huang, CJ; Lu, CH; Shih, KC, 2023)	1.34

Role	Description
antineoplastic agent	A substance that inhibits or prevents the proliferation of neoplasms.
[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]

Class	Description
homodetic cyclic peptide	A homodetic cyclic peptide is a cyclic peptide in which the ring consists solely of amino-acid residues in peptide linkages.
peptide hormone	Any peptide with hormonal activity in animals, whether endocrine, neuroendocrine, or paracrine.
[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	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
Somatostatin receptor type 1	Homo sapiens (human)	Ki	0.0063	0.0003	0.4123	2.3920	AID203390
Somatostatin receptor type 2	Homo sapiens (human)	Ki	0.0010	0.0000	0.4091	4.7200	AID203409
Somatostatin receptor type 4	Homo sapiens (human)	Ki	0.1000	0.0006	0.2733	3.2000	AID203570
Somatostatin receptor type 3	Homo sapiens (human)	Ki	0.0008	0.0001	0.0320	0.1290	AID203551
Somatostatin receptor type 5	Homo sapiens (human)	Ki	0.0001	0.0001	0.4479	4.0700	AID203709
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
interferon gamma precursor	Homo sapiens (human)	AC50	15.9000	0.1280	15.1730	38.6100	AID1259418
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger	Somatostatin receptor type 1	Homo sapiens (human)
glutamate receptor signaling pathway	Somatostatin receptor type 1	Homo sapiens (human)
spermatogenesis	Somatostatin receptor type 1	Homo sapiens (human)
negative regulation of cell population proliferation	Somatostatin receptor type 1	Homo sapiens (human)
cerebellum development	Somatostatin receptor type 1	Homo sapiens (human)
forebrain development	Somatostatin receptor type 1	Homo sapiens (human)
somatostatin signaling pathway	Somatostatin receptor type 1	Homo sapiens (human)
response to starvation	Somatostatin receptor type 1	Homo sapiens (human)
cellular response to leukemia inhibitory factor	Somatostatin receptor type 1	Homo sapiens (human)
cellular response to estradiol stimulus	Somatostatin receptor type 1	Homo sapiens (human)
neuropeptide signaling pathway	Somatostatin receptor type 1	Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger	Somatostatin receptor type 2	Homo sapiens (human)
adenylate cyclase-inhibiting G protein-coupled receptor signaling pathway	Somatostatin receptor type 2	Homo sapiens (human)
spermatogenesis	Somatostatin receptor type 2	Homo sapiens (human)
negative regulation of cell population proliferation	Somatostatin receptor type 2	Homo sapiens (human)
cerebellum development	Somatostatin receptor type 2	Homo sapiens (human)
peristalsis	Somatostatin receptor type 2	Homo sapiens (human)
forebrain development	Somatostatin receptor type 2	Homo sapiens (human)
somatostatin signaling pathway	Somatostatin receptor type 2	Homo sapiens (human)
response to starvation	Somatostatin receptor type 2	Homo sapiens (human)
cellular response to glucocorticoid stimulus	Somatostatin receptor type 2	Homo sapiens (human)
cellular response to estradiol stimulus	Somatostatin receptor type 2	Homo sapiens (human)
neuropeptide signaling pathway	Somatostatin receptor type 2	Homo sapiens (human)
G protein-coupled receptor signaling pathway	Somatostatin receptor type 4	Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger	Somatostatin receptor type 4	Homo sapiens (human)
negative regulation of cell population proliferation	Somatostatin receptor type 4	Homo sapiens (human)
cell migration	Somatostatin receptor type 4	Homo sapiens (human)
forebrain development	Somatostatin receptor type 4	Homo sapiens (human)
somatostatin signaling pathway	Somatostatin receptor type 4	Homo sapiens (human)
positive regulation of ERK1 and ERK2 cascade	Somatostatin receptor type 4	Homo sapiens (human)
positive regulation of arachidonic acid secretion	Somatostatin receptor type 4	Homo sapiens (human)
negative regulation of adenylate cyclase-activating G protein-coupled receptor signaling pathway	Somatostatin receptor type 4	Homo sapiens (human)
neuropeptide signaling pathway	Somatostatin receptor type 4	Homo sapiens (human)
cellular response to glucocorticoid stimulus	Somatostatin receptor type 4	Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger	Somatostatin receptor type 3	Homo sapiens (human)
cell-cell signaling	Somatostatin receptor type 3	Homo sapiens (human)
spermatogenesis	Somatostatin receptor type 3	Homo sapiens (human)
negative regulation of cell population proliferation	Somatostatin receptor type 3	Homo sapiens (human)
hormone-mediated apoptotic signaling pathway	Somatostatin receptor type 3	Homo sapiens (human)
cerebellum development	Somatostatin receptor type 3	Homo sapiens (human)
forebrain development	Somatostatin receptor type 3	Homo sapiens (human)
somatostatin signaling pathway	Somatostatin receptor type 3	Homo sapiens (human)
response to starvation	Somatostatin receptor type 3	Homo sapiens (human)
cellular response to glucocorticoid stimulus	Somatostatin receptor type 3	Homo sapiens (human)
cellular response to estradiol stimulus	Somatostatin receptor type 3	Homo sapiens (human)
neuropeptide signaling pathway	Somatostatin receptor type 3	Homo sapiens (human)
G protein-coupled receptor signaling pathway	Somatostatin receptor type 5	Homo sapiens (human)
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger	Somatostatin receptor type 5	Homo sapiens (human)
negative regulation of cell population proliferation	Somatostatin receptor type 5	Homo sapiens (human)
positive regulation of cytokinesis	Somatostatin receptor type 5	Homo sapiens (human)
somatostatin signaling pathway	Somatostatin receptor type 5	Homo sapiens (human)
cellular response to glucocorticoid stimulus	Somatostatin receptor type 5	Homo sapiens (human)
neuropeptide signaling pathway	Somatostatin receptor type 5	Homo sapiens (human)
regulation of insulin secretion	Somatostatin receptor type 5	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
somatostatin receptor activity	Somatostatin receptor type 1	Homo sapiens (human)
protein binding	Somatostatin receptor type 1	Homo sapiens (human)
neuropeptide binding	Somatostatin receptor type 1	Homo sapiens (human)
protein binding	Somatostatin receptor type 2	Homo sapiens (human)
PDZ domain binding	Somatostatin receptor type 2	Homo sapiens (human)
somatostatin receptor activity	Somatostatin receptor type 2	Homo sapiens (human)
neuropeptide binding	Somatostatin receptor type 2	Homo sapiens (human)
protein binding	Somatostatin receptor type 4	Homo sapiens (human)
somatostatin receptor activity	Somatostatin receptor type 4	Homo sapiens (human)
neuropeptide binding	Somatostatin receptor type 4	Homo sapiens (human)
somatostatin receptor activity	Somatostatin receptor type 3	Homo sapiens (human)
signaling receptor binding	Somatostatin receptor type 3	Homo sapiens (human)
protein binding	Somatostatin receptor type 3	Homo sapiens (human)
neuropeptide binding	Somatostatin receptor type 3	Homo sapiens (human)
G protein-coupled receptor activity	Somatostatin receptor type 3	Homo sapiens (human)
protein binding	Somatostatin receptor type 5	Homo sapiens (human)
neuropeptide binding	Somatostatin receptor type 5	Homo sapiens (human)
somatostatin receptor activity	Somatostatin receptor type 5	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
plasma membrane	Somatostatin receptor type 1	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 1	Homo sapiens (human)
neuron projection	Somatostatin receptor type 1	Homo sapiens (human)
cytosol	Somatostatin receptor type 2	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 2	Homo sapiens (human)
neuron projection	Somatostatin receptor type 2	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 2	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 4	Homo sapiens (human)
neuron projection	Somatostatin receptor type 4	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 4	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 3	Homo sapiens (human)
cilium	Somatostatin receptor type 3	Homo sapiens (human)
ciliary membrane	Somatostatin receptor type 3	Homo sapiens (human)
non-motile cilium	Somatostatin receptor type 3	Homo sapiens (human)
neuron projection	Somatostatin receptor type 3	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 3	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 5	Homo sapiens (human)
plasma membrane	Somatostatin receptor type 5	Homo sapiens (human)
neuron projection	Somatostatin receptor type 5	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Assay ID	Title	Year	Journal	Article
AID1346332	Human SST3 receptor (Somatostatin receptors)	2004	Neuroendocrinology, , Volume: 80 Suppl 1	Functional activity of the multiligand analog SOM230 at human recombinant somatostatin receptor subtypes supports its usefulness in neuroendocrine tumors.
AID1346384	Human SST1 receptor (Somatostatin receptors)	2004	Neuroendocrinology, , Volume: 80 Suppl 1	Functional activity of the multiligand analog SOM230 at human recombinant somatostatin receptor subtypes supports its usefulness in neuroendocrine tumors.
AID1346419	Rat SST2 receptor (Somatostatin receptors)	2011	Molecular endocrinology (Baltimore, Md.), Jun, Volume: 25, Issue:6	Ligand-dependent mechanisms of sst2A receptor trafficking: role of site-specific phosphorylation and receptor activation in the actions of biased somatostatin agonists.
AID1346419	Rat SST2 receptor (Somatostatin receptors)	2010	Molecular endocrinology (Baltimore, Md.), Jan, Volume: 24, Issue:1	Agonist-biased signaling at the sst2A receptor: the multi-somatostatin analogs KE108 and SOM230 activate and antagonize distinct signaling pathways.
AID1346413	Human SST5 receptor (Somatostatin receptors)	2004	Neuroendocrinology, , Volume: 80 Suppl 1	Functional activity of the multiligand analog SOM230 at human recombinant somatostatin receptor subtypes supports its usefulness in neuroendocrine tumors.
AID1346424	Human SST2 receptor (Somatostatin receptors)	2004	Neuroendocrinology, , Volume: 80 Suppl 1	Functional activity of the multiligand analog SOM230 at human recombinant somatostatin receptor subtypes supports its usefulness in neuroendocrine tumors.
AID203390	Binding affinity towards human Somatostatin receptor type 1 (sst1) using Tyr11-[125I]-SRIF as radioligand was determined in CHO cells	2003	Journal of medicinal chemistry, Jun-05, Volume: 46, Issue:12	A novel somatostatin mimic with broad somatotropin release inhibitory factor receptor binding and superior therapeutic potential.
AID203570	Binding affinity towards human Somatostatin receptor type 4 (sst4) using Tyr11-[125I]-SRIF as radioligand was determined in CHO cells	2003	Journal of medicinal chemistry, Jun-05, Volume: 46, Issue:12	A novel somatostatin mimic with broad somatotropin release inhibitory factor receptor binding and superior therapeutic potential.
AID203709	Binding affinity towards human Somatostatin receptor type 5 (sst5) using Tyr11-[125I]-SRIF as radioligand was determined in COS cell	2003	Journal of medicinal chemistry, Jun-05, Volume: 46, Issue:12	A novel somatostatin mimic with broad somatotropin release inhibitory factor receptor binding and superior therapeutic potential.
AID179248	In vitro inhibition of GHRH induced GH release in primary cultures of rat pituitary cells	2003	Journal of medicinal chemistry, Jun-05, Volume: 46, Issue:12	A novel somatostatin mimic with broad somatotropin release inhibitory factor receptor binding and superior therapeutic potential.
AID203409	Binding affinity towards human Somatostatin receptor type 2 (sst2) using Tyr11-[125I]-SRIF as radioligand was determined in CHO cells	2003	Journal of medicinal chemistry, Jun-05, Volume: 46, Issue:12	A novel somatostatin mimic with broad somatotropin release inhibitory factor receptor binding and superior therapeutic potential.
AID203551	Binding affinity towards human Somatostatin receptor type 3 (sst3) using Tyr11-[125I]-SRIF as radioligand was determined in CHO cells	2003	Journal of medicinal chemistry, Jun-05, Volume: 46, Issue:12	A novel somatostatin mimic with broad somatotropin release inhibitory factor receptor binding and superior therapeutic potential.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	60 (14.39)	29.6817
2010's	287 (68.82)	24.3611
2020's	70 (16.79)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	86 (20.24%)	5.53%
Reviews	110 (25.88%)	6.00%
Case Studies	39 (9.18%)	4.05%
Observational	2 (0.47%)	0.25%
Other	188 (44.24%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (79)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Evaluation of the Effect of Pasireotide LAR Administration in the Lymphocele Prevention After Axillary Node Dissection for Breast Cancer [NCT01356862]	Phase 2	91 participants (Actual)	Interventional	2010-09-30	Completed
Phase II Study of the IGF-1 Inhibitor Pasireotide Lar in Combination With the m-TOR Inhibitor Everolimus in Patients With Relapsed/Refractory Multiple Myeloma [NCT01234974]	Phase 2	0 participants (Actual)	Interventional	2010-12-31	Withdrawn(stopped due to Study never undertaken)
Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor: A Proof of Principle Trial [NCT01372644]	Phase 1	15 participants (Actual)	Interventional	2007-11-30	Completed
A Phase I, Multi-center, Open-label, Dose Escalation Study of Pasireotide (SOM230) LAR in Patients With Advanced Neuroendocrine Tumors (NETs) [NCT01364415]	Phase 1	29 participants (Actual)	Interventional	2011-08-31	Completed
Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor [NCT01372618]	Phase 1/Phase 2	9 participants (Actual)	Interventional	2011-06-30	Terminated(stopped due to PI has passed away. Requested by department to terminate study.)
Pasireotide for Prevention of Hypoglycemia in Patients With Hyperinsulinemic Hypoglycemia [NCT03053284]	Phase 2	0 participants (Actual)	Interventional	2017-04-30	Withdrawn(stopped due to Funding was withdrawn by Sponsor prior to start of study)
Assessing Efficacy of Combining Pasireotide With Aspiration Sclerotherapy to Improve Volume Reduction of Dominant Hepatic Cysts: a Randomized, Double-blind, Placebo-controlled Clinical Trial. [NCT02048319]	Phase 3	34 participants (Actual)	Interventional	2013-12-31	Completed
Phase 1 Study to Evaluate Safety, and Preliminary Efficacy of Pasireotide LAR in Castration Resistant Prostate Cancer [NCT01646684]	Phase 1	9 participants (Actual)	Interventional	2013-03-08	Completed
Phase II Study of SOM230 LAR in Combination With Bortezomib and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma [NCT01329289]	Phase 2	0 participants (Actual)	Interventional	2011-12-31	Withdrawn(stopped due to Clinical trial being transferred to Columbia University with the Investigator.)
Pasireotide in the Treatment of Hypoglycemia Following Gastric Bypass Surgery [NCT03514576]	Phase 4	5 participants (Anticipated)	Interventional	2018-06-01	Enrolling by invitation
Treatment of Hypoglycemia Following Gastric Bypass Surgery [NCT02527993]	Phase 4	11 participants (Actual)	Interventional	2015-10-31	Completed
A Three-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Subcutaneous Doses of HTL0030310 in Healthy Subjects [NCT03847207]	Phase 1	42 participants (Actual)	Interventional	2019-02-13	Completed
Reduction by Pasireotide of the Effluent Volume in High-output Enterostomy in Patients Refractory to Usual Medical Treatment : Phase II Multicentric Randomized Double Bland Placebo Controlled Study [NCT02713776]	Phase 2	57 participants (Actual)	Interventional	2016-12-13	Completed
An Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study [NCT01263353]	Phase 1	36 participants (Actual)	Interventional	2010-11-30	Completed
A Phase II Study of RAD001 (Everolimus) and Pasireotide (SOM230) LAR in Patients With Advanced Uveal Melanoma [NCT01252251]	Phase 2	14 participants (Actual)	Interventional	2010-11-30	Completed
Phase II Study of Pasireotide LAR in Patients With Metastatic Neuroendocrine Carcinomas [NCT01253161]	Phase 2	29 participants (Actual)	Interventional	2011-02-01	Completed
Impact of Pasireotide on Postoperative Pancreatic Fistulas Following Distal Resections [NCT04281680]		258 participants (Actual)	Observational	2014-07-01	Completed
An Open Label, Multicenter, Single Arm Study of Pasireotide LAR in Patients With Rare Tumors of Neuroendocrine Origin [NCT00958841]	Phase 2	118 participants (Actual)	Interventional	2009-09-30	Terminated(stopped due to Slow recruitment rate into this study with rare tumors of neuroendocrine origin (enrollment issues))
Effect of Pasireotide LAR on Gonadotroph Adenomas: A Pilot Study [NCT00929669]	Phase 2	2 participants (Actual)	Interventional	2009-06-30	Terminated(stopped due to unable to identify a third subject)
A Proof of Concept and Open-label Study to Test the Efficacy and Safety of Pasireotide in Patients With Ectopic ACTH-producing Tumors [NCT02780882]	Phase 2	0 participants (Actual)	Interventional	2015-12-31	Withdrawn(stopped due to Due to stringent inclusion/exclusion criteria, study investigator deemed it not feasible.)
Efficacy and Safety of Pasireotide Long Acting Release (LAR) in Combination With Weekly Pegvisomant in Previously Controlled Acromegaly Patients on Combination Treatment of Long-Acting Somatostatin Analogues and Weekly Pegvisomant [NCT02668172]	Phase 4	60 participants (Actual)	Interventional	2015-08-31	Active, not recruiting
HYPAR Trial - Hydrocortisone vs Pasireotide in Reducing Pancreatic Fistula and Other Complications After Pancreatic Resection - a Prospective, Randomized, Controlled Trial [NCT02775227]	Phase 4	126 participants (Actual)	Interventional	2016-05-31	Active, not recruiting
A Multicenter, Randomized, Blinded Efficacy and Safety Study of Pasireotide LAR vs Octreotide LAR in Patients With Metastatic Carcinoid Tumors Whose Disease-related Symptoms Are Inadequately Controlled by Somatostatin Analogues. [NCT00690430]	Phase 3	186 participants (Actual)	Interventional	2008-04-30	Completed
Efficacy and Feasibility of Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis - a Phase II Randomized Multicentric T [NCT04826432]	Phase 2	217 participants (Anticipated)	Interventional	2020-09-03	Suspended(stopped due to No more experimental drugs available)
Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess [NCT00994110]	Phase 3	439 participants (Actual)	Interventional	2009-10-31	Completed
A Phase I, Open-label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function [NCT00698464]	Phase 1	34 participants (Actual)	Interventional	2008-07-31	Completed
A Phase II Study of SOM230 in Patients With Recurrent or Progressive Meningioma Who Have Previously Undergone or Are Not Candidates for Additional Surgery or Radiation [NCT00813592]	Phase 2	2 participants (Actual)	Interventional	2008-11-30	Terminated(stopped due to Original PI left and company withdrew support.)
Phase I Study of Pasireotide (SOM230) in Combination With RAD001 in Patients With Advanced Neuroendocrine Tumors [NCT00804336]	Phase 1	22 participants (Actual)	Interventional	2008-10-31	Completed
A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) Subcutaneous (sc) Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease [NCT00434148]	Phase 3	162 participants (Actual)	Interventional	2006-12-31	Completed
Extension to a Multi-Center, Randomized, Crossover, Open Label, Dose Finding Study to Compare the Safety, Efficacy, and Pharmacokinetics/Pharmacodynamics (PK/PD) Relationship of Multiple Doses of Pasireotide (SOM230) (200, 400, and 600 μg Bid) and Doses o [NCT00171730]	Phase 2	30 participants (Actual)	Interventional	2004-08-24	Completed
An ACromegaly, Open-label, Multi-CEnter, Safety Monitoring Program for Treating Patients With SOM230 (Pasireotide) LAR Who Have Need to Receive Medical Therapy (ACCESS) [NCT01995734]		0 participants	Expanded Access		Approved for marketing
Phase I Study of Combination of SOM 230 Long Acting Release (LAR) + Gemcitabine in Locally Advanced or Metastatic Pancreatic Cancer [NCT01385956]	Phase 1	20 participants (Actual)	Interventional	2011-06-30	Completed
A Phase III, Multicenter, Randomized, Parallel-group Study to Assess the Efficacy and Safety of Double-blind Pasireotide LAR 40 mg and Pasireotide LAR 60 mg Versus Open-label Octreotide LAR or Lanreotide ATG in Patients With Inadequately Controlled Acrome [NCT01137682]	Phase 3	198 participants (Actual)	Interventional	2010-07-19	Completed
Extension to a Multicenter, Open-label Study to Assess the Safety and Efficacy of 600 μg SOM230, Administered Subcutaneously, Bid in Patients With Cushing's Disease [NCT00171951]	Phase 2	19 participants (Actual)	Interventional	2004-08-13	Completed
An Open Label Randomized Phase II Study of SOM230 and Everolimus in Castrate-Resistant, Chemotherapy-Naïve Prostate Cancer Patients [NCT01313559]	Phase 2	6 participants (Actual)	Interventional	2011-06-30	Terminated(stopped due to Slow accrual)
Randomized Phase II Trial Evaluating the Efficiency of Pasireotide for the Treatment of Gastrointestinal Angiodysplasia in Endoscopic Treatment Failure [NCT02622906]	Phase 2	24 participants (Actual)	Interventional	2012-03-31	Completed
A Multicenter, Randomized, Blinded Study to Assess Safety and Efficacy of Pasireotide LAR vs. Octreotide LAR in Patients With Active Acromegaly [NCT00600886]	Phase 3	358 participants (Actual)	Interventional	2008-02-11	Completed
A Phase II Trial of SOM230(PasireotideLAR) and Topotecan in Patients With Relapsed or Refractory Small Cell Lung Cancer [NCT01417806]	Phase 2	28 participants (Anticipated)	Interventional	2011-07-31	Recruiting
A Multicenter, Randomized, Crossover, Open Label Dose Finding Study to Compare the Safety, Efficacy and PK/PD Relationship of Multiple Doses of SOM230 and Sandostatin in Acromegalic Patients [NCT00088582]	Phase 2	62 participants (Actual)	Interventional	2004-03-31	Completed
A Phase I, Exploratory, Intra-patient Dose Escalation Study to Investigate the Preliminary Safety, Pharmacokinetics, and Anti-tumor Activity of Pasireotide (SOM230) s.c.Followed by Pasireotide LAR in Patients With Metastaticmelanoma or Metastatic Merkel C [NCT01652547]	Phase 1	10 participants (Actual)	Interventional	2012-11-30	Completed
Phase IB/II Study of Pasireotide, Everolimus and Selective Internal Radioembolization Therapy (SIRT) for Unresectable Neuroendocrine Hepatic Metastases [NCT01469572]	Phase 1	13 participants (Actual)	Interventional	2011-12-31	Completed
A Phase I, Multicenter, Open-label, Randomized Study Assessing the Pharmacokinetics, Safety, and Tolerability of Monthly Doses of Pasireotide i.m. LAR Injection in Patients With Acromegaly and Patients With Carcinoid Disease [NCT00446082]	Phase 1	85 participants (Actual)	Interventional	2006-06-30	Completed
An Open-Label, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of Pasireotide LAR on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma [NCT01283542]	Phase 2	20 participants (Actual)	Interventional	2012-11-26	Completed
A Multicenter, Open-label, Randomized, Phase II Study to Evaluate Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Pasireotide LAR in Japanese Patients With Active Acromegaly or Pituitary Gigantism [NCT01673646]	Phase 2	33 participants (Actual)	Interventional	2012-10-16	Completed
Exploratory Randomized, Placebo-controlled Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome [NCT01895296]	Phase 2	9 participants (Actual)	Interventional	2008-09-30	Completed
A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in Patients With Cushing's Disease [NCT00088608]	Phase 2	26 participants (Actual)	Interventional	2004-04-30	Completed
Phase 2, Double-Blind, Randomized, Single Center Trial to Assess the Mechanism(s) Responsible for the Effect of the Somatostatin Analogue SOM230 (Pasireotide) in Healthy Male Volunteers. Version #2 05/09/2009 [NCT01128192]	Phase 2	45 participants (Actual)	Interventional	2009-08-31	Completed
A Double-blind Randomized Placebo-controlled Dose-finding Phase II Study to Assess the Efficacy and Safety of Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia [NCT05928390]	Phase 2	72 participants (Anticipated)	Interventional	2023-10-31	Not yet recruiting
A 3-Arm Randomized Phase II Trial Evaluating Single Agent and Combined Efficacy of Pasireotide and Everolimus in Adult Patients With Radioiodine-Refractory Differentiated and Medullary Thyroid Cancer [NCT01270321]	Phase 2	42 participants (Actual)	Interventional	2010-11-30	Completed
Mono Centre, Open Label Proof of Concept Study SOM230 in Progressive Medullary Thyroid Cancer Patients and the Combination With RAD001 Upon Progression [NCT01625520]	Phase 2	19 participants (Actual)	Interventional	2012-02-29	Completed
Phase II Single Arm Study of Everolimus and Pasireotide (SOM230) in Patients With Advanced or Metastatic Hepatocellular Carcinoma (HCC) [NCT01488487]	Phase 2	24 participants (Actual)	Interventional	2011-12-31	Completed
Adipokine Profile in Patients With Cushing's Disease on Pasireotide Treatment: Correlation With Disease Activity, Insulin Sensitivity and Secretion Parameters [NCT03080181]	Phase 4	24 participants (Actual)	Interventional	2013-05-31	Completed
Prevention of Gastrointestinal Toxicity From Total Body Irradiation or High Dose Chemotherapy With Pasireotide [NCT02215070]	Phase 2	37 participants (Actual)	Interventional	2015-01-21	Completed
Phase I/II Trial to Establish the Safety and Preliminary Efficacy of the Combination of Docetaxel, Prednisone, and SOM 230 (Pasireotide) in Metastatic Castrate Resistant Prostate Cancer (CRPC). [NCT01468532]	Phase 1/Phase 2	18 participants (Actual)	Interventional	2011-10-31	Completed
Phase II Trial of SOM230 (Pasireotide LAR) in Patients With Unresectable Hepatocellular Carcinoma (HCC) [NCT01639352]	Phase 2	20 participants (Actual)	Interventional	2012-07-31	Completed
A Phase IIIb Multicenter, Open-label, Single Arm Study to Evaluate the Efficacy and Safety of Pasireotide in Patients With Acromegaly Inadequately Controlled With First Generation Somatostatin Analogues [NCT02354508]	Phase 3	123 participants (Actual)	Interventional	2015-03-31	Completed
Pilot Study of Pasireotide LAR Treatment of Silent Corticotrophin Pituitary Tumors and Effects on Plasma Levels of POMC [NCT02749227]	Phase 2	4 participants (Actual)	Interventional	2017-07-10	Terminated(stopped due to Lack of funding)
Phase I Trial of Combination of FOLFIRI and SOM 230 in Advanced Gastrointestinal Malignancies [NCT01434069]	Phase 1	16 participants (Actual)	Interventional	2011-09-30	Completed
An Open-label, Multicenter, Phase II Study Evaluating the Safety and Efficacy of Twice Daily Dosing of SOM230 in Patients With Metastatic Carcinoid Tumors [NCT00088595]	Phase 2	45 participants (Actual)	Interventional	2004-01-31	Completed
Compassionate Use of SOM230 for Individual Patient (NS, 14-Jan-1986) With Hyperinsulinemic/Hypoglycemia [NCT02835131]		0 participants	Expanded Access		No longer available
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Pasireotide LAR in Patients With Cushing's Disease [NCT01374906]	Phase 3	150 participants (Actual)	Interventional	2011-11-04	Completed
A Phase I, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous (s.c.) Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to a Matched Control Group of Healthy Volunteers [NCT01578928]	Phase 1	50 participants (Actual)	Interventional	2012-05-31	Completed
"Extension Study to the Open-label Phase I Study Evaluating the Safety and Tolerability of Pasireotide LAR in Combination With Everolimus in Advanced Metastatic NETs - The COOPERATE-1 Study" [NCT01590199]	Phase 1	18 participants (Actual)	Interventional	2012-05-18	Completed
An Open Label, Longitudinal Study of the Effects of Subcutaneous Acute and Chronic Pasireotide (som230) Therapy on Adrenocorticotrophic Hormone and Tumour Volume in Patients With Nelson's Syndrome [NCT01617733]	Phase 2	8 participants (Actual)	Interventional	2011-03-31	Terminated(stopped due to Inadequate patient recruitment)
Somatostatin and Dopamine Receptors Expression in Non-functioning Pituitary Adenomas and Resistant Prolactinomas: Correlation With in Vitro and in Vivo Responsiveness to Somatostatin Analogs and Dopamine Agonist [NCT01620138]	Phase 2/Phase 3	21 participants (Actual)	Interventional	2010-03-31	Completed
Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size [NCT02021942]	Phase 2	16 participants (Actual)	Interventional	2012-03-31	Completed
Treatment Plan for an Individual Patient With Pasireotide for Hyperinsulinemic Hypoglycemia [NCT03103009]	Phase 1	1 participants (Actual)	Interventional	2017-03-22	Completed
Pasireotide Treatment for Insulin Producing Pancreatic Neuro-endocrine Tumor [NCT02779257]	Phase 4	0 participants (Actual)	Interventional	2016-04-30	Withdrawn(stopped due to Subject passed away prior to enrollment)
Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study) [NCT02310269]		200 participants (Anticipated)	Observational	2013-03-28	Recruiting
A Randomized, Open-label Phase II Multicenter Study Evaluating the Efficacy of Oral Everolimus Alone or in Combination With Pasireotide LAR i.m. in Advanced Progressive Pancreatic Neuroendocrine Tumors (PNET) - The COOPERATE-2 Study [NCT01374451]	Phase 2	160 participants (Actual)	Interventional	2011-06-30	Terminated(stopped due to The study was stopped for not meeting the primary endpoint for PFS.)
An Open Label, Multi-center Pasireotide Roll-over Protocol for Patients Who Have Completed a Previous Novartis-sponsored Pasireotide Study and Are Judged by the Investigator to Benefit From Continued Pasireotide Treatment [NCT01794793]	Phase 4	413 participants (Actual)	Interventional	2013-06-10	Active, not recruiting
A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome [NCT01637272]	Phase 2	43 participants (Actual)	Interventional	2013-01-08	Completed
A Multicenter, Placebo-Controlled, Single Dose Study in Acute Episodic and Chronic Cluster Headache to Evaluate the Safety and Efficacy of SOM230 Subcutaneous (s.c.) [NCT02619617]	Phase 2	28 participants (Actual)	Interventional	2016-10-31	Terminated(stopped due to Novartis decision based on Cohort 1 results)
Phase II Study of Monthly SOM230C for Recurrent or Progressive Meningioma [NCT00859040]	Phase 2	34 participants (Actual)	Interventional	2009-03-31	Completed
A Phase II Trial to Assess the Efficacy and Safety of Pasireotide s.c. Alone or in Combination With Cabergoline in Patients With Cushing's Disease [NCT01915303]	Phase 2	68 participants (Actual)	Interventional	2014-03-06	Terminated
A Randomized, Placebo Controlled Clinical Trial of SOM230 (Pasireotide LAR) In Severe Polycystic Liver Disease [NCT01670110]	Phase 2	48 participants (Actual)	Interventional	2012-08-31	Completed
Multicenter 3-arm Trial to Evaluate the Efficacy and Safety of Pasireotide LAR or Everolimus Alone or in Combination in Patients With Well Differentiated Neuroendocrine Carcinoma of the Lung and Thymus - LUNA Trial [NCT01563354]	Phase 2	124 participants (Actual)	Interventional	2013-08-16	Completed
A Multi-center, Randomized, Open-label, Phase IV Study to Investigate the Management of Pasireotide-induced Hyperglycemia With Incretin Based Therapy or Insulin in Adult Patients With Cushing's Disease or Acromegaly [NCT02060383]	Phase 4	249 participants (Actual)	Interventional	2014-05-23	Completed
An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape). [NCT01582061]	Phase 3	104 participants (Actual)	Interventional	2011-08-16	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
NCT00088595 (5) [back to overview]	Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary
NCT00088595 (5) [back to overview]	Duration of Partial Symptom Control (Days) by Dose Class
NCT00088595 (5) [back to overview]	Duration of Complete Symptom Control (Days) by Dose Class
NCT00088595 (5) [back to overview]	The Overall Safety and Tolerability of Pasireotide
NCT00088595 (5) [back to overview]	The Number of Patients (Participants) With Overall Tumor Response
NCT00171730 (6) [back to overview]	Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class
NCT00171730 (6) [back to overview]	Percentage of Participants With One or More Adverse Events (AEs)
NCT00171730 (6) [back to overview]	Time to Tumor Response
NCT00171730 (6) [back to overview]	Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation
NCT00171730 (6) [back to overview]	Percentage of Participants With Symptoms of Acromegaly
NCT00171730 (6) [back to overview]	Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes
NCT00171951 (6) [back to overview]	Plasma Trough Concentrations (Ctrough) of Pasireotide in UFC Responders
NCT00171951 (6) [back to overview]	Change From Baseline in Serum Cortisol Levels
NCT00171951 (6) [back to overview]	Change From Baseline in Plasma Adrenocorticotropic Hormone (ACTH) Levels
NCT00171951 (6) [back to overview]	Change From Baseline in Mean Urinary Free Cortisol (UFC)
NCT00171951 (6) [back to overview]	Percentage of Responders With Mean Urinary Free Cortisol (UFC) Within Normal Limits
NCT00171951 (6) [back to overview]	Number of Participants Who Had At Least One Adverse Event (AE)
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference
NCT00434148 (15) [back to overview]	Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)
NCT00434148 (15) [back to overview]	Percent Change From Baseline in Serum Cortisol
NCT00434148 (15) [back to overview]	Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides
NCT00434148 (15) [back to overview]	Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group
NCT00434148 (15) [back to overview]	Time to First UFC Response
NCT00434148 (15) [back to overview]	Change From Baseline in mUFC
NCT00434148 (15) [back to overview]	Change From Baseline in Tumor Volume
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score
NCT00434148 (15) [back to overview]	Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)
NCT00600886 (30) [back to overview]	Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1
NCT00600886 (30) [back to overview]	Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover
NCT00600886 (30) [back to overview]	Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1
NCT00600886 (30) [back to overview]	Percentage of Participants With Normalization of IGF-1
NCT00600886 (30) [back to overview]	Pasireotide Trough Concentrations by Incident Dose
NCT00600886 (30) [back to overview]	Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
NCT00600886 (30) [back to overview]	Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L
NCT00600886 (30) [back to overview]	Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover
NCT00600886 (30) [back to overview]	Percentage of Participants With Normalization of IGF-1
NCT00600886 (30) [back to overview]	Change From Extension Baseline in Tumor Volume After Crossover
NCT00600886 (30) [back to overview]	Percentage of Participants With Normalization of IGF-1 After Crossover
NCT00600886 (30) [back to overview]	Ring Size
NCT00600886 (30) [back to overview]	Ring Size After Crossover
NCT00600886 (30) [back to overview]	Ring Size After Crossover
NCT00600886 (30) [back to overview]	Severity Scores of Acromegaly Symptoms
NCT00600886 (30) [back to overview]	Severity Scores of Acromegaly Symptoms After Crossover
NCT00600886 (30) [back to overview]	Summary of Mean GH Values
NCT00600886 (30) [back to overview]	Summary of Mean GH Values After Crossover
NCT00600886 (30) [back to overview]	Summary of Prolactin Levels
NCT00600886 (30) [back to overview]	Summary of Prolactin Levels After Crossover
NCT00600886 (30) [back to overview]	Duration of Response for Patients Achieving a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1 at Month 12 (No. of Responders: Pasireotide LAR = 51, Octreotide LAR = 32)
NCT00600886 (30) [back to overview]	Time to First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 (No. of Responders: Pasireotite LAR = 81, Octreotide LAR = 63) )
NCT00600886 (30) [back to overview]	Change From Baseline in Tumor Volume
NCT00600886 (30) [back to overview]	Change From Baseline in Tumor Volume at 12 Months
NCT00600886 (30) [back to overview]	Health-related Quality-of-life as Measured by the AcroQoL Questionnaire
NCT00600886 (30) [back to overview]	Health-related Quality-of-life as Measured by the AcroQoL Questionnaire After Crossover
NCT00600886 (30) [back to overview]	Octreotide Trough Concentrations by Incident Dose
NCT00600886 (30) [back to overview]	Octreotide Trough Concentrations by Incident Dose
NCT00600886 (30) [back to overview]	Octreotide Trough Concentrations by Incident Dose
NCT00600886 (30) [back to overview]	Pasireotide Trough Concentrations by Incident Dose
NCT00690430 (5) [back to overview]	Percentage of Patients Who Achieved Clinical Symptom Improvement by Randomization Stratum and Treatment.
NCT00690430 (5) [back to overview]	Improvement in Daily Mean Number of Flushing Episodes by Randomization Stratum and Treatment.
NCT00690430 (5) [back to overview]	Improvement in Daily Mean Number of Diarrhea Bowel Movement Episodes by Randomization Stratum and Treatment.
NCT00690430 (5) [back to overview]	Pasireotide LAR vs. Octreotide LAR on Disease Control Rate Based on RECIST Criteria
NCT00690430 (5) [back to overview]	Objective Tumor Response Rate Assessed by Investigator
NCT00813592 (1) [back to overview]	To Characterize the Safety and Tolerability of SOM230
NCT00859040 (6) [back to overview]	Median Time to Progression
NCT00859040 (6) [back to overview]	Treatment-related Events
NCT00859040 (6) [back to overview]	Response Rate
NCT00859040 (6) [back to overview]	Overall Survival
NCT00859040 (6) [back to overview]	Median Progression-Free Survival
NCT00859040 (6) [back to overview]	6 Month Progression Free Survival
NCT00929669 (2) [back to overview]	Number of Participants With Change in Serum FSH Concentration (mIU/mL) in Patients Who Have Gonadotroph Adenomas Treated With Pasireotide.
NCT00929669 (2) [back to overview]	Number of Participants With Change in Size of the Adenoma by ≥3 mm in at Least Two Dimensions as Determined by MRI
NCT00958841 (6) [back to overview]	Percentage of Responders at Month 6 - Individual NETs
NCT00958841 (6) [back to overview]	Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
NCT00958841 (6) [back to overview]	Percentage of Responders With Probability of Success at Month 6 - Individual NETs
NCT00958841 (6) [back to overview]	Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
NCT00958841 (6) [back to overview]	PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
NCT00958841 (6) [back to overview]	PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
NCT00994110 (1) [back to overview]	To Compare 60-day ≥Grade 3 Pancreatic Complication Rates (Fistula, Leak, and Abscess) as Defined by the MSKCC Surgical Secondary Events System Between Patients Who Receive Perioperative SOM230 and Saline Placebo.
NCT01128192 (11) [back to overview]	Change in High Dose % Endogenous Glucose Production (EGP) Inhibition
NCT01128192 (11) [back to overview]	Change in Insulin Basal Level
NCT01128192 (11) [back to overview]	Change in Low Dose % Endogenous Glucose Production (EGP) Inhibition
NCT01128192 (11) [back to overview]	Change in Low-Dose Glucose Disposal Rate (GDR)
NCT01128192 (11) [back to overview]	Change in Area Under the Curve (AUC) of Plasma Glucose 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)
NCT01128192 (11) [back to overview]	Change in Area Under the Curve (AUC) of Plasma Insulin 0-30mins, 30-180mins, 0-180mins During Oral Glucose Tolerance Test (OGTT)
NCT01128192 (11) [back to overview]	Change in Area Under the Curve (AUC) of Plasma Insulin Level 0-10mins, 10-180mins, 0-180mins During Hyperglycemic Clamp
NCT01128192 (11) [back to overview]	Change in High-Dose Glucose Disposal Rate (GDR)
NCT01128192 (11) [back to overview]	Change Fasting Plasma Insulin Level
NCT01128192 (11) [back to overview]	Change in Basal Endogenous Glucose Production (EGP)
NCT01128192 (11) [back to overview]	Change in Fasting Plasma Glucose Level
NCT01137682 (16) [back to overview]	Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.
NCT01137682 (16) [back to overview]	Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly
NCT01137682 (16) [back to overview]	Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set).
NCT01137682 (16) [back to overview]	Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
NCT01137682 (16) [back to overview]	Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set)
NCT01137682 (16) [back to overview]	Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set)
NCT01252251 (3) [back to overview]	Number of Participants With Stable Disease (SD)
NCT01252251 (3) [back to overview]	Median Progression Free Survival(PFS)
NCT01252251 (3) [back to overview]	Median Overall Survival (OS)
NCT01253161 (3) [back to overview]	Adverse Events Possibly Related to Study Treatment
NCT01253161 (3) [back to overview]	Progression-free Survival (PFS) at One Year
NCT01253161 (3) [back to overview]	Overall Radiographic Response Rate (ORR)
NCT01270321 (2) [back to overview]	Number of Participants With Response Per Responsive Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0)
NCT01270321 (2) [back to overview]	Number of Participants With Progression-free Survival
NCT01283542 (20) [back to overview]	Percentage of Participants Reporting Absence and Presence of Relevant Disease-related Symptoms (FAS)
NCT01283542 (20) [back to overview]	Percentage of Patients Achieving Tumour Volume Reduction in Main Phase (FAS)
NCT01283542 (20) [back to overview]	Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Extension Phase (FAS)
NCT01283542 (20) [back to overview]	Mean Alpha Subunit Levels in Main and Extension Phases (FAS)
NCT01283542 (20) [back to overview]	Mean Cortisol Hormone Levels During Main and Extension Phases (FAS)
NCT01283542 (20) [back to overview]	Mean TSH Hormone Levels During Main and Extension Phases (FAS)
NCT01283542 (20) [back to overview]	Tumor Volume Change From Baseline in Main Phase (FAS)
NCT01283542 (20) [back to overview]	Tumor Volume in Extension Phase (FAS)
NCT01283542 (20) [back to overview]	Tumor Volume Main Phase (FAS)
NCT01283542 (20) [back to overview]	Tumor Volume Percent Change From Baseline in Extension Phase (FAS)
NCT01283542 (20) [back to overview]	Tumor Volume Change From Baseline in Extension Phase (FAS)
NCT01283542 (20) [back to overview]	Tumor Volume Percent Change From Baseline in Main Phase (FAS)
NCT01283542 (20) [back to overview]	Percentage of Patients Achieving Tumour Volume Reduction of at Least ≥ 20% in Main Phase (FAS)
NCT01283542 (20) [back to overview]	Percentage of Patients Achieving Tumour Volume Reduction in Extension Phase (FAS)
NCT01283542 (20) [back to overview]	Mean Testosterone and Free T4 Hormone Levels During Main and Extension Phases (FAS)
NCT01283542 (20) [back to overview]	Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
NCT01283542 (20) [back to overview]	Mean LH and FSH Hormone Levels During Main and Extension Phases (FAS)
NCT01283542 (20) [back to overview]	Mean GH and IGF-1 Hormone Levels During Main and Extension Phases (FAS)
NCT01283542 (20) [back to overview]	Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
NCT01283542 (20) [back to overview]	Percentage of Participants With Reduction From Baseline of Alpha Subunit ≥50% in Main and Extension Phases (FAS)
NCT01313559 (4) [back to overview]	Number of Participants With > 50% Decline From Baseline PSA Level
NCT01313559 (4) [back to overview]	Number of Participants Alive and Progression Free After 12 Weeks of Treatment
NCT01313559 (4) [back to overview]	Number of Participants With Progression Free Survival (PFS) Based on RECIST 1.1 Criteria
NCT01313559 (4) [back to overview]	Number of Participants Without New Bone Lesions After 12 Weeks of Treatment
NCT01374451 (10) [back to overview]	Summary of Pharmacokinetics (PK) for Everolimus for Tmax
NCT01374451 (10) [back to overview]	Overall Survival (OS) Using Kaplan Meier Method
NCT01374451 (10) [back to overview]	Disease Control Rate (DCR) as Per Radiology Review
NCT01374451 (10) [back to overview]	Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg
NCT01374451 (10) [back to overview]	Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin
NCT01374451 (10) [back to overview]	Objective Response Rate (ORR) as Per Radiology Review
NCT01374451 (10) [back to overview]	Progression-free Survival (PFS) Per Local Radiological Review
NCT01374451 (10) [back to overview]	Summary of Pharmacokinetics (PK) for Everolimus for AUClast
NCT01374451 (10) [back to overview]	Summary of Pharmacokinetics (PK) for Everolimus for CL/F
NCT01374451 (10) [back to overview]	Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR
NCT01374906 (33) [back to overview]	Percentage of Participants Having a Favorable Shift From Baseline in Clinical Signs
NCT01374906 (33) [back to overview]	Actual Change From Baseline in Clinical Signs Over Time: Blood Pressure
NCT01374906 (33) [back to overview]	Percentage Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 Regardless of Dose Titration
NCT01374906 (33) [back to overview]	Percentage of Participants That Attained a mUFC ≤ 1.0 x ULN at Month 7 and Had Not Had a Dose Increase at Month 4
NCT01374906 (33) [back to overview]	Actual Change From Baseline in Clinical Signs Over Time: Weight
NCT01374906 (33) [back to overview]	Actual Change From Baseline in Clinical Signs Over Time: Waist Circumference
NCT01374906 (33) [back to overview]	Actual Change From Baseline in Clinical Signs Over Time: Body Mass Index (BMI)
NCT01374906 (33) [back to overview]	Actual Change From Baseline in Clinical Signs Over Time: Body Composition: Region
NCT01374906 (33) [back to overview]	Percentage Change in Mean Urinary Free Cortisol (mUFC) From Baseline
NCT01374906 (33) [back to overview]	Percentage Change From Baseline on Serum Cortisol Over Time
NCT01374906 (33) [back to overview]	Percentage of Patients Who Attain mUFC ≤1.0 x ULN or Have at Least 50 % Reduction From Baseline in mUFC
NCT01374906 (33) [back to overview]	Percentage of Patients With Uncontrolled Response at Month 7 & Month 12 Within the Subset of Patients Who Had Uncontrolled Response at a) Months 1 and 2; b) Months 1, 2, and 3
NCT01374906 (33) [back to overview]	Pharmacokinetic (PK) Parameter: Cmax
NCT01374906 (33) [back to overview]	Pharmacokinetic (PK) Parameter: Cmax
NCT01374906 (33) [back to overview]	Pharmacokinetic (PK) Parameter: Cmax
NCT01374906 (33) [back to overview]	Pharmacokinetic (PK) Parameter: Ctrough
NCT01374906 (33) [back to overview]	Pharmacokinetic (PK) Parameter: Ctrough
NCT01374906 (33) [back to overview]	Pharmacokinetic (PK) Parameter: Ctrough
NCT01374906 (33) [back to overview]	Percentage Change From Baseline on Plasma Adrenocorticotropic Hormone (ACTH) Over Time
NCT01374906 (33) [back to overview]	Percentage Change From Baseline in Clinical Signs Over Time
NCT01374906 (33) [back to overview]	Percent of Participants With a Duration of at Least 50% Reduction in mUFC From Baseline at Indicated Time Points
NCT01374906 (33) [back to overview]	Percent of Participants Attaining a Time to First Achievement of at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points
NCT01374906 (33) [back to overview]	Percent of Participants Attaining a mUFC ≤ 1.0 x ULN or at Least a 50% Reduction in mUFC From Baseline at Indicated Time Points
NCT01374906 (33) [back to overview]	Percent of Participants Attaining a Duration of Controlled or Partially Controlled Response at Indicated Time Points
NCT01374906 (33) [back to overview]	Actual Change in SF-12v2 Score From Baseline - Physical Component Summary
NCT01374906 (33) [back to overview]	Actual Change in Standardized Score of Cushing's Disease HRQoL (CushingQOL) Score From Baseline
NCT01374906 (33) [back to overview]	Actual Change in SF-12v2 Score From Baseline - Mental Component Summary
NCT01374906 (33) [back to overview]	Actual Change in Mean Urinary Free Cortisol (mUFC) From Baseline
NCT01374906 (33) [back to overview]	Actual Change From Baseline in Clinical Signs Over Time: Cholesterol & Triglycerides
NCT01374906 (33) [back to overview]	Percentage of Patients Who Attain mUFC ≤ 1.0 x ULN
NCT01374906 (33) [back to overview]	Percentage of Patients Who Are Controlled Responders (mUFC ≤ 1.0 xULN) on at Least 4 of the 7 mUFC Assessments by Month 7 & on at Least 7 of the 12 mUFC Assessments by Month 12.
NCT01374906 (33) [back to overview]	Percentage of Patients That Attain a Reduction of at Least 50% in mUFC From Baseline
NCT01374906 (33) [back to overview]	Percentage of Participants That Attained a Mean Urinary Free Cortisol (mUFC) <= 1.0 x Upper Limit of Normal (ULN) at Month 7 Regardless of Dose Up-titration at Month 4.
NCT01468532 (9) [back to overview]	Maximum Tolerated Dose (MTD) of Pasireotide in Combination With Docetaxel and Prednisone by the Occurrence of Adverse Events and the Associated Grade Per NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
NCT01468532 (9) [back to overview]	Measurements of Tumor Using Response Evaluation Criteria In Solid Tumors (RECIST) Criteria Before and After Treatment With the Combination of Pasireotide in Combination With Docetaxel
NCT01468532 (9) [back to overview]	Overall Survival (OS)
NCT01468532 (9) [back to overview]	Time to Progression (TTP)
NCT01468532 (9) [back to overview]	Measurement of Levels of IGF-1, Serum Chromogranin A (SCA), and Neuron Specific Enolase (NSE), the Change Between Time Points Pre-therapy, Post-therapy
NCT01468532 (9) [back to overview]	Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy
NCT01468532 (9) [back to overview]	Percentage Prostate-specific Antigen (PSA) Change Noted
NCT01468532 (9) [back to overview]	Pharmacokinetics (PK) of SOM230
NCT01468532 (9) [back to overview]	The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0
NCT01488487 (4) [back to overview]	Time to Progression (TTP)
NCT01488487 (4) [back to overview]	Objective Response Rate (ORR)
NCT01488487 (4) [back to overview]	Number of Individuals Experiencing Toxicity
NCT01488487 (4) [back to overview]	Overall Survival (OS)
NCT01563354 (12) [back to overview]	Summary of Duration of Response (Months)
NCT01563354 (12) [back to overview]	Summary of Time to Response (Months)
NCT01563354 (12) [back to overview]	Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set)
NCT01563354 (12) [back to overview]	Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment
NCT01563354 (12) [back to overview]	Summary of Progression-free Survival (PFS) Based on RECIST v1.1
NCT01563354 (12) [back to overview]	12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)
NCT01563354 (12) [back to overview]	Biochemical Response Rate (BRR) for 5HIAA Levels
NCT01563354 (12) [back to overview]	Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels
NCT01563354 (12) [back to overview]	Kaplan-Meier Estimates of Progression-free Survival (PFS)
NCT01563354 (12) [back to overview]	Kaplan-Meier Event-free Probability Estimate Based on CgA Levels
NCT01563354 (12) [back to overview]	Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels
NCT01563354 (12) [back to overview]	Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)
NCT01582061 (14) [back to overview]	Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)
NCT01582061 (14) [back to overview]	Percent Change From Baseline in Growth Hormone (GH) Values
NCT01582061 (14) [back to overview]	Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values
NCT01582061 (14) [back to overview]	Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI)
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference
NCT01582061 (14) [back to overview]	Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight
NCT01582061 (14) [back to overview]	Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline
NCT01582061 (14) [back to overview]	Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
NCT01620138 (1) [back to overview]	Tumor Volume Changes for NFPA and Prolactin Level Changes for Prolactinoma
NCT01637272 (19) [back to overview]	Insulin Levels During OGTT
NCT01637272 (19) [back to overview]	Pasireotide Concentrations in LAR Phase
NCT01637272 (19) [back to overview]	Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
NCT01637272 (19) [back to overview]	Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
NCT01637272 (19) [back to overview]	Response Rate in Hematocrit Levels
NCT01637272 (19) [back to overview]	Response Rate in Pulse Rate
NCT01637272 (19) [back to overview]	Summary of LAR PK Parameters by Dose
NCT01637272 (19) [back to overview]	LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
NCT01637272 (19) [back to overview]	Patient Global Assessment at the End of Months 3, 6 and 12
NCT01637272 (19) [back to overview]	Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
NCT01637272 (19) [back to overview]	Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
NCT01637272 (19) [back to overview]	Response Rate in Plasma Glucose Level
NCT01637272 (19) [back to overview]	Response Rate in Plasma Glucose Level
NCT01637272 (19) [back to overview]	Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
NCT01637272 (19) [back to overview]	Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
NCT01637272 (19) [back to overview]	Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
NCT01637272 (19) [back to overview]	Glucagon Levels During OGTT
NCT01637272 (19) [back to overview]	Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
NCT01637272 (19) [back to overview]	Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
NCT01639352 (5) [back to overview]	Overall Response Rate (ORR)
NCT01639352 (5) [back to overview]	Disease Control Rate (DCR)
NCT01639352 (5) [back to overview]	Toxicity Profile of Protocol Therapy
NCT01639352 (5) [back to overview]	Rate of Progression-Free Survival (PFS):
NCT01639352 (5) [back to overview]	Rate of Overall Survival (OS)
NCT01670110 (8) [back to overview]	Percentage Change in Estimated Glomerular Filtration Rate (eGFR)
NCT01670110 (8) [back to overview]	Percent Change in Blood Glucose
NCT01670110 (8) [back to overview]	Change in Kidney Volume
NCT01670110 (8) [back to overview]	Change in Quality of Life
NCT01670110 (8) [back to overview]	Percentage Change in Serum Creatinine
NCT01670110 (8) [back to overview]	Change in Liver Volume
NCT01670110 (8) [back to overview]	Percentage Change in Hemoglobin A1C
NCT01670110 (8) [back to overview]	Percentage Change in Heart Rate
NCT01673646 (18) [back to overview]	Percentage of Overall Participants With the Reduction of Mean GH Levels to <2.5 ug/L by Visit (Extension Phase)
NCT01673646 (18) [back to overview]	Summary of Pasireotide LAR PK Parameter of Accumulation Ratio Randomized Dose Level
NCT01673646 (18) [back to overview]	Response Rate at Month 3 by Randomized Dose Level
NCT01673646 (18) [back to overview]	IGF-1 Response at Month 3 by Randomized Dose
NCT01673646 (18) [back to overview]	GH Response at Month 3 by Randomized Dose
NCT01673646 (18) [back to overview]	Percentage of Overall Participants With the Reduction of GH Levels to <2.5 ug/L by Visit (Core Phase)
NCT01673646 (18) [back to overview]	Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Extension Phase)
NCT01673646 (18) [back to overview]	Percentage of Overall Participants With the Normalization of IGF-1 by Visit (Core Phase)
NCT01673646 (18) [back to overview]	Number of Participants With Acromegaly Symptoms or Pituitary Gigantism (Core Phase)
NCT01673646 (18) [back to overview]	Change of Tumor Volume From Baseline
NCT01673646 (18) [back to overview]	Change in Ring Size From Baseline
NCT01673646 (18) [back to overview]	Change in Mean GH Levels From Baseline
NCT01673646 (18) [back to overview]	Change From Baseline in Prolactin
NCT01673646 (18) [back to overview]	Summary of Pasireotide LAR PK Parameters of Ctrough & Cmax by Randomized Dose Level
NCT01673646 (18) [back to overview]	Change From Baseline in Mean GH by Visit and SSA Uncontrolled Status (Extension Phase)
NCT01673646 (18) [back to overview]	Total-group Response Rate by Visit (Extension Phase)
NCT01673646 (18) [back to overview]	Total-group Response Rate (GH & IGF-1) Over Time (Core Phase)
NCT01673646 (18) [back to overview]	Total-group Response Rate at Month 3
NCT01915303 (22) [back to overview]	Mean Scores of SF-12v2 Domain Scores at Week 17 and 35
NCT01915303 (22) [back to overview]	Duration (Weeks) of Controlled or Partially Controlled Response
NCT01915303 (22) [back to overview]	LDL, HDL and Total Cholesterol at Week 35
NCT01915303 (22) [back to overview]	Mean Scores of Cushing QoL Standardized Score at Week 17 and 35
NCT01915303 (22) [back to overview]	Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN Collected or Imputed at Week 35
NCT01915303 (22) [back to overview]	Body Mass Index at Week 35
NCT01915303 (22) [back to overview]	Plasma Adrenocorticotropic Hormone (ACTH)
NCT01915303 (22) [back to overview]	Body Weight at Week 35
NCT01915303 (22) [back to overview]	Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Dorsal Fat Pad
NCT01915303 (22) [back to overview]	Mean Urinary Free Cortisol (mUFC) at Scheduled Visits
NCT01915303 (22) [back to overview]	Sitting Diastolic Blood Pressure at Week 35
NCT01915303 (22) [back to overview]	Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Hirsutism
NCT01915303 (22) [back to overview]	Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Facial Rubor
NCT01915303 (22) [back to overview]	Waist Circumference at Week 35
NCT01915303 (22) [back to overview]	Sitting Systolic Blood Pressure at Week 35
NCT01915303 (22) [back to overview]	Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Striae
NCT01915303 (22) [back to overview]	Serum Cortisol Levels
NCT01915303 (22) [back to overview]	Percentage of Responders With Mean Urinary Free Cortisol (mUFC) ≤ 1.0xULN
NCT01915303 (22) [back to overview]	Percentage of Participants Who Attain mUFC ≤ 1.0 x ULN or Have at Least 50% Reduction From Baseline in mUFC
NCT01915303 (22) [back to overview]	Number of Patients With Shift From Standing Easily to Not Being Able to Stand
NCT01915303 (22) [back to overview]	Number of Participants With Shift From Mild to Severe in Clinical Signs of Hypercortisolism
NCT01915303 (22) [back to overview]	Number of Participants With Improvement in Clinical Symptom of Hypercortisolism From Baseline - Supraclavicular Fat Pad
NCT02021942 (6) [back to overview]	Assessment of Tumor Operability
NCT02021942 (6) [back to overview]	Health Related Quality of Life
NCT02021942 (6) [back to overview]	Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
NCT02021942 (6) [back to overview]	Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations
NCT02021942 (6) [back to overview]	Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status
NCT02021942 (6) [back to overview]	Percent Change in Tumor Volume From Baseline to EOS
NCT02060383 (7) [back to overview]	Change in HbA1c From Randomization (R) Over Time Per Randomized Arm
NCT02060383 (7) [back to overview]	Change in HbA1c From Randomization to Approximately 16 Weeks
NCT02060383 (7) [back to overview]	Absolute Change in FPG From Baseline to End of Core Phase
NCT02060383 (7) [back to overview]	Percentage of Participants in the Incretin-based Arm Who Required Anti-diabetic Rescue Therapy With Insulin
NCT02060383 (7) [back to overview]	Percentage of Participants With ≤ 0.3% HbA1c Increase to End of Core Phase
NCT02060383 (7) [back to overview]	Absolute Change in HbA1c From Baseline to End of Core Phase
NCT02060383 (7) [back to overview]	Change in FPG (Fasting Plasma Glucose) From Randomization Until End of Core Phase
NCT02215070 (7) [back to overview]	Disease Free Survival Compared to Historical Controls
NCT02215070 (7) [back to overview]	Incidence of Chronic GVHD Compared to Historical Controls
NCT02215070 (7) [back to overview]	Overall Survival Compared to Historical Controls
NCT02215070 (7) [back to overview]	Percentage of Acute GVHD
NCT02215070 (7) [back to overview]	Maximum Severity of Acute GVHD Compared to Historical Controls
NCT02215070 (7) [back to overview]	Maximum Severity of Chronic GVHD Compared to Historical Controls
NCT02215070 (7) [back to overview]	Percentage of GI Toxicity From the Preparatory Regimen and the GVHD Prophylaxis in Stem Cell Transplantation (SCT) Patients Who Are Treated With Pasireotide
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With IGF-1
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 Overall by Baseline Diabetic Status
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1
NCT02354508 (28) [back to overview]	Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline
NCT02354508 (28) [back to overview]	Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline
NCT02354508 (28) [back to overview]	Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline
NCT02354508 (28) [back to overview]	Extension (Ext.) Phase: Percentage of Participants With Acromegaly Shift Symptoms From Extension Baseline to Most Extreme Post-extension Baseline
NCT02354508 (28) [back to overview]	Extension Phase: Percentage of Participants With Mean GH < 1 μg/L at Weeks 48, 60, 72 and Overall, Pasireotide Montherapy and Pasireotide With Concomittant Medication and by GH Level at Screening
NCT02354508 (28) [back to overview]	Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 and 72 (Overall by Baseline Diabetic Status)
NCT02354508 (28) [back to overview]	Extension Phase: Percentage of Participants With Mean GH < 1 μg/L and IGF-1 < ULN at Weeks 48, 60 & 72 (Up-titrated to Pasireotide LAR 60 mg)
NCT02354508 (28) [back to overview]	Core Phase: Change in Mean Growth Hormone (GH) Values From Baseline to Week 36
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants Reporting Levels 0 - 4 by Dimensions of Acromegaly Symptoms
NCT02354508 (28) [back to overview]	Extension Phase: Percentage of Participants Reporting Levels 1 - 5 by Dimensions of Acromegaly Symptoms
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Acromegaly Shift Symptoms From Baseline to Most Extreme Post-baseline
NCT02354508 (28) [back to overview]	Core Phase: Change in Standardized IGF-1 Values From Baseline to Week 36
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH <1 μg/L and IGF-1
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall - LOCF
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 for Participants Up-titrated to Pasireotide LAR 60 mg
NCT02354508 (28) [back to overview]	Core Phase: Change From Baseline in EQ-5D-5L Index Scores
NCT02354508 (28) [back to overview]	Core Phase: Change From Baseline in EQ-5D-5L VAS Assessment
NCT02354508 (28) [back to overview]	Core Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)
NCT02354508 (28) [back to overview]	Extension Phase: Change From Baseline in Scores as Measured by Acromegaly Quality of Life (AcroQoL)
NCT02354508 (28) [back to overview]	Extension Phase: Change From Baseline in EQ-5D-5L VAS Assessment
NCT02354508 (28) [back to overview]	Extension Phase: Change From Baseline in EQ-5D-5L Index Scores
NCT02354508 (28) [back to overview]	Core Phase: Percentage of Participants With Mean GH < 1 g/L and IGF-1 < ULN at Week 36 by Previous Treatment and Overall
NCT02619617 (4) [back to overview]	Number of Participants Who Were Pain Free at 30 Minutes Post Dose
NCT02619617 (4) [back to overview]	Change in Hemoglobin Values From Screening to End of Study
NCT02619617 (4) [back to overview]	Pulse Rate
NCT02619617 (4) [back to overview]	Number of Participants With Headache Response (PD Analysis Set)

Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary

"Complete Symptom Control: an average of ≤ 3 bowel movements per day for at least 15 consecutive days, with no more than 3 episodes on any given day, and no episodes of flushing over the time interval being studied.~Partial Symptom Control: an average of < 4 bowel movements per day for at least 15 consecutive days, with no more than 6 episodes per given day, and an average of fewer than 2 daily flushing episodes over the same given time interval.~Treatment failure: Failure to obtain partial or complete treatment success over a consecutive 15-day period at a constant dose level." (NCT00088595)
Timeframe: 15 days

Intervention	participants (Number)
	Complete symptom control	Partial symptom control	No control
Pasireotide (Any Dose)	3	9	32

Intervention	Days (Mean)
Pasireotide >900-≤1500 μg	89.8
Pasireotide >1500-≤2400 μg	36.3
Pasireotide Any Dose	72.0

Intervention	Days (Mean)
Pasireotide >900 - ≤1500 μg	42.0
Pasireotide >1500 - ≤2400 μg	47.0
Pasireotide Any Dose	43.7

Intervention	Participants (Number)
	Death	Serious or Significant Events	Serious Adverse Events (SAEs)	Discontinued due to Adverse Events (AEs)
Pasireotide (Any Dose)	1	23	14	12

Intervention	Participants (Number)
	Complete response for complete treatment success	Partial response for complete treatment success	Stable disease for complete treatment success	Progressive disease for complete treatment success	Unknown for complete treatment success	Missing for complete treatment success	Complete response for partial treatment success	Partial response for partial treatment success	Stable disease for partial treatment success	Progressive disease for partial treatment success	Unknown for partial treatment success	Missing for partial treatment success	Complete response for treatment failure	Partial response for treatment failure	Stable disease for treatment failure	Progressive disease for treatment failure	Unknown for treatment failure	Missing for treatment failure
Pasireotide (Any Dose)	0	0	1	0	0	0	0	0	4	0	0	0	0	0	8	10	1	20

Intervention	percentage of responders (Number)
Pasireotide s.c. <1200 μg/d	20
Pasireotide s.c. 1200 to <1500 μg/d	28.6
Pasireotide s.c. ≥1500 μg/d	14.3
Pasireotide s.c. Overall	23.1

Intervention	percentage of participants (Number)
Pasireotide s.c. <1200 μg/d	80.0
Pasireotide s.c. 1200 to <1500 μg/d	86.7
Pasireotide s.c. ≥1500 μg/d	91.7

Intervention	percentage of participants (Number)
	Sitting and Reading - 0	Sitting and Reading - 1	Sitting and Reading - 2	Sitting and Reading - 3	Sitting and Reading - Not Done	Watching TV - 0	Watching TV - 1	Watching TV - 2	Watching TV - 3	Watching TV - Not Done	Sitting, Inactive in a Public Place - 0	Sitting, Inactive in a Public Place - 1	Sitting, Inactive in a Public Place - 2	Sitting, Inactive in a Public Place - 3	Sitting, Inactive in a Public Place - Not Done	Passenger in a Car, an Hour Without Break - 0	Passenger in a Car, an Hour Without Break - 1	Passenger in a Car, an Hour Without Break - 2	Passenger in a Car, an Hour Without Break - 3	Passenger in a Car, an Hour Without Break - Not Done	Lying Down to Rest in the Afternoon - 0	Lying Down to Rest in the Afternoon - 1	Lying Down to Rest in the Afternoon - 2	Lying Down to Rest in the Afternoon - 3	Lying Down to Rest in the Afternoon - Not Done	Sitting and Talking to Someone - 0	Sitting and Talking to Someone - 1	Sitting and Talking to Someone - 2	Sitting and Talking to Someone - 3	Sitting and Talking to Someone - Not Done	Sitting Quietly After a Lunch Without Alcohol - 0	Sitting Quietly After a Lunch Without Alcohol - 1	Sitting Quietly After a Lunch Without Alcohol - 2	Sitting Quietly After a Lunch Without Alcohol - 3	Sitting Quietly After a Lunch Without Alcohol - Not Done	In a Car, Stopped a Few Minutes in the Traffic - 0	In a Car, Stopped a Few Minutes in the Traffic - 1	In a Car, Stopped a Few Minutes in the Traffic - 2	In a Car, Stopped a Few Minutes in the Traffic - 3	In a Car, Stopped a Few Minutes in the Traffic - Not Done
Pasireotide s.c. Overall	36.7	23.3	23.3	0	16.7	23.3	33.3	23.3	3.3	16.7	56.7	20	6.7	0	16.7	60	10	6.7	6.7	16.7	13.3	23.3	23.3	23.3	16.7	76.7	6.7	0	0	16.7	30	23.3	20	10	16.7	73.3	10	0	0	16.7

Intervention	percentage of participants (Number)
	Headache - 0	Headache - 1	Headache - 2	Headache - 3	Headache - 4	Headache - Not Done	Perspiration - 0	Perspiration - 1	Perspiration - 2	Perspiration - 3	Perspiration - 4	Perspiration - Not Done	Paresthesiae - 0	Paresthesiae - 1	Paresthesiae - 2	Paresthesiae - 3	Paresthesiae - 4	Paresthesiae - Not Done	Fatigue - 0	Fatigue - 1	Fatigue - 2	Fatigue - 3	Fatigue - 4	Fatigue - Not Done	Osteoarthralgia - 0	Osteoarthralgia - 1	Osteoarthralgia - 2	Osteoarthralgia - 3	Osteoarthralgia - 4	Osteoarthralgia - Not Done	Carpal Tunnel Syndrome - 0	Carpal Tunnel Syndrome - 1	Carpal Tunnel Syndrome - 2	Carpal Tunnel Syndrome - 3	Carpal Tunnel Syndrome - 4	Carpal Tunnel Syndrome - Not Done
Pasireotide s.c. Overall	46.7	26.7	6.7	0	0	20	20	33.3	23.3	3.3	0	20	50	16.7	13.3	0	0	20	26.7	26.7	13.3	13.3	0	20	40	23.3	10	3.3	3.3	20	56.7	10	10	3.3	0	20

Intervention	cubic millimeter (mm) (Mean)
	Core Study Baseline	Month 9	Month 27	Month 63	Month 75	Month 99
Pasireotide s.c. Overall	4457.4	2839.3	2536	456	1016	180

Intervention	nanograms per milliliter (ng/mL) (Mean)
	Day 15 (Core Study)	Month 6
Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC	7.0	17.4

Intervention	nanomoles per liters (nmol/L) (Mean)
	Core Baseline	Change from Core Baseline to Day 15	Change from Core Baseline to Month 6	Change from Core Baseline to Month 12	Change from Core Baseline to Month 24	Change from Core Baseline to Month 105
Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC	723.60	-25.96	-150.60	-66.06	-227.53	-166.00

Intervention	nanomoles per 24 hours (nmol/24h) (Mean)
	Core Baseline	Change from Core Baseline to Day 14/Day 15	Change from Core Baseline to Month 6	Change from Core Baseline to Month 12	Change from Core Baseline to Month 24	Change from Core Baseline to Month 102
Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC	1219.74	-710.57	-801.85	-1202.1	-1241.1	-2417.0

Intervention	mg/cm^3 (Mean)
	Lumbar vertebrae, month 3 (n=2,2)	Lumbar vertebrae, month 6 (n=47,39)	Lumbar vertebrae, month 12 (n=33,29)	Lumbar vertebrae, month 24 (n=16,16)	Lumbar vertebrae, month 36 (n=8,9)	Lumbar vertebrae, month 48 (n=9,8)	Lumbar vertebrae, month 60 (n=7,6)	Proximal femur (total hip), month 3 (2,2)	Proximal femur (total hip), month 6 (n=46,38)	Proximal femur (total hip), month 12 (n=33,26)	Proximal femur (total hip), month 24 (n=16,13)	Proximal femur (total hip), month 36 (n=8,8)	Proximal femur (total hip), month 48 (n=8,8)	Proximal femur (total hip), month 60 (n=7,6)	Proximal femur (femur neck), month 3 (n=2,2)	Proximal femur (femur neck), month 6 (n=46,38)	Proximal femur (femur neck), month 12 (n=33,28)	Proximal femur (femur neck), month 24 (n=16,14)	Proximal femur (femur neck), month 36 (n=8,8)	Proximal femur (femur neck), month 48 (n=9,7)	Proximal femur (femur neck), month 60 (7,6)
Pasireotide 600 ug	0	0	0	0	0	0	0	0	0	0	0	0	0	-0.1	0	0	0	0	0	0	0
Pasireotide 900 ug	0	0	0	0	0.1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Intervention	cm (Mean)
	month 3 (n=64,66)	month 6 (n=53,54)	month 12(n=34,35)	month 24 ( n=17,22)	month 36 (n=9,13)	month 48 (n=8,10)	month 60 (n=7,8)
Pasireotide 600 ug	-1.0	-1.9	-4.4	-8.7	-7.8	-8.3	-7.3
Pasireotide 900 ug	-2.2	-3.4	-5.6	-5.1	-6.4	-5.1	-4.6

Intervention	percent change (Mean)
	month 0.5 (n=78,75)	month 1 (n=78,71)	month 1.5 (n=74,69)	month 2 (n=72,66)	month 2.5 (n=69,65)	month 3 (n=69,66)	month 4 (n=66,61)	month 5 (n=62,55)	month 6 (n=58,55)	month 7 (n=52,52)	month 8 (n=48,46)	month 9 (n=46,47)	month 10 (n=42,46)	month 11 (n=42,40)	month 12 (n=39,39)	month 15 (n=26,26)	month 18 (n=26,25)	month 21 (n=20,23)	month 24 (n=18,21)	month 27 (n=16,18)	month 30 (n=14,18)	month 33 (n=13,14)	month 36 (n=10,13)	month 39 (n=10,12)	month 42 (n=10,12)	month 45 (n=9,11)	month 48 (n=9,9)	month 51 (n=9,9)	month 54 (n=9,9)	month 57 (n=7,7)	month 60 (n=8,8)	month 63 (n=6,7)	month 66 (n=4,6)	month 69 (n=3,5)	month 72 (n=3,3)	month 75 (n=2,3)	month 78 (n=1,1)
Pasireotide 600 ug	9.3	-10.0	-13.4	-7.7	-8.2	-9.2	-7.2	-3.0	-8.4	-11.4	-5.0	-5.3	-10.2	-11.5	-7.4	-14.5	-5.9	-1.5	-10.9	-10.4	-14.7	-9.4	19.1	-20.9	-6.7	11.9	-10.8	0.0	4.6	9.6	9.6	11.9	25.3	38.9	35.6	-5.0	50.0
Pasireotide 900 ug	-15.9	-19.1	-10.5	-13.2	-12.0	-16.3	-12.8	-15.0	-17.3	-14.6	-17.0	-18.2	-18.2	-17.4	-26.5	-16.3	-21.2	-17.3	-18.0	-12.5	-20.0	-2.4	1.2	-5.3	2.7	8.1	11.7	-3.1	7.3	-5.0	-1.3	15.4	18.3	-1.2	22.0	23.1	-11.1

Intervention	Percent change (Mean)
	month 0.5 (n=77,76)	month 1 (n=78,72)	month 1.5 (n=75,71)	month 2 (n=73,67)	month 2.5 (n=70,67)	month 3 (n=70,67)	month 4 (n=68,61)	month 5 (n=62,58)	month 6 (n=59,57)	month 7 (n=52,53)	month 8 (n=50,46)	month 9 (n=46,48)	month 10 (n=42,47)	month 11 (n=41,41)	month 12 (n=39,38)	month 15 (n=26,26)	month 18 (n=26,25)	month 21 (n=21,25)	month 24 (n=18,22)	month 27 (n=16,18)	month 30 (n=14,19)	month 33 (n=13,15)	month 36 (n=10,13)	month 39 (n=10,12)	month 42 (n=10,12)	month 45 (n=10,11)	month 48 (n=9,11)	month 51 (n=9,9)	month 54 (n=9,9)	month 57 (n=8,8)	month 60 (n=8,8)	month 63 (n=6,7)	month 66 (n=4,6)	month 69 (n=3,5)	month 72 (n=3,4)	month 75 (n=2,3)	month 78 (n=1,1)
Pasireotide 600 ug	-4.0	-7.3	-5.5	-0.7	-3.3	-2.6	-6.9	-4.3	-5.6	-9.8	-10.2	-5.4	-11.2	-8.2	-11.6	-10.5	-7.6	-12.1	-17.9	-9.0	-22.8	-9.5	-12.7	-26.6	-17.8	-12.5	-19.7	-17.6	-25.0	-11.0	-24.5	-28.6	-6.7	-13.4	-4.5	-63.3	14.5
Pasireotide 900 ug	-10.8	-7.7	-7.1	-6.4	-10.1	-10.2	-10.8	-10.8	-9.3	-5.8	-9.9	-5.8	-9.3	-14.0	-15.2	-12.5	-17.8	-15.5	-18.1	-12.7	-22.7	-25.2	-13.3	-25.9	-18.1	-8.5	-20.1	-24.0	-6.8	-30.8	-18.9	-24.0	-22.5	-33.6	-22.7	-23.2	-53.3

Intervention	Percentage change in HRQL score (Mean)
	month 3 (n=67,66)	month 6 (n= 55,56)	month 12 (n=20,20)
Pasireotide 600 ug	20.7	19.6	54.9
Pasireotide 900 ug	40.1	52.2	111.5

Intervention	mmol/L (Mean)
	Cholesterol, month 3 (n=70,67)	Cholesterol, month 6 (n=59,55)	Cholesterol, month 12 (n=40,39)	Cholesterol, month 24 (n=18,22)	Cholesterol, month 36 (n=10,12)	Cholesterol, month 48 (n=9,10)	Cholesterol, month 60 (n=8,8)	Triglycerides, month 3 (n=70,67)	Triglycerides, month 6 (n=59,55)	Triglycerides, month 12 (n=40,39)	Triglycerides, month 24 (n=18,22)	Triglycerides, month 36 (n=10,12)	Triglycerides, month 48 (n=9,10)	Triglycerides, month 60 (n=8,8)
Pasireotide 600 ug	-0.2	-0.4	-0.5	-0.6	-0.8	-0.9	-1.5	0.1	0	-0.1	0	-0.2	-0.5	-0.7
Pasireotide 900 ug	-0.3	-0.4	-0.6	-0.3	-0.1	-0.4	-0.4	0.1	0.1	-0.2	0	0.3	0.4	0.2

Intervention	nmol/24h (Mean)
	month 3 (n=61,62)	month 12 (n=37,35)
Pasireotide 600 ug	-375.8	-572.6
Pasireotide 900 ug	-343.4	-350.7

Intervention	cm^3 (Mean)
	month 6 (n=25, 28)	month 12 (n=15, 18)	month 18 (n=8, 11)	month 24 (n=7, 13)	month 30 (n=6, 8)	month 36 (n=3, 5)	month 42 (n=3, 3)	month 48 (n=3, 3)	month 54 (n=3, 2)	month 60 (n=3, 2)	month 66 (n= 1, 1)	month 72 (n=1, 0)	month 78 (n=1, 0)
Pasireotide 600 ug	9.3	-8.1	-18.1	-27.4	-52.1	-94.1	-95.2	-20.5	-29.1	-13.5	-100.0	45.6	77.2
Pasireotide 900 ug	-19.0	-43.8	-36.0	-11.5	-20.9	-27.6	84.0	29.2	20.3	127.6	269.8	NA	NA

pasireotide

Description

Cross-References

Synonyms (38)

Research Excerpts

Overview

Effects

Actions

Treatment

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Dosage Studied

Roles (1)

Drug Classes (2)

Protein Targets (6)

Inhibition Measurements

Other Measurements

Biological Processes (23)

Molecular Functions (6)

Ceullar Components (6)

Bioassays (12)

Research

Studies (417)

Market Indicators

Research Demand Index: 53.72

Study Types

Clinical Trials (79)

Trial Overview

Trial Outcomes

Symptom Control (Diarrhea/Flushing) Using a Patient Symptom Diary

Duration of Partial Symptom Control (Days) by Dose Class

Duration of Complete Symptom Control (Days) by Dose Class

The Overall Safety and Tolerability of Pasireotide

The Number of Patients (Participants) With Overall Tumor Response

Percentage of Participants With Growth Hormone (GH) and Insulin-like Growth Factor 1 (IGF-1) Observed Response by Dose Class

Percentage of Participants With One or More Adverse Events (AEs)

Time to Tumor Response

Percentage of Participants With Sleep Apnea Symptoms as Assessed by Epworth Sleepiness Scale by Situation

Percentage of Participants With Symptoms of Acromegaly

Summary Magnetic Resonance Imaging (MRI) Pituitary Tumor Volumes

Plasma Trough Concentrations (Ctrough) of Pasireotide in UFC Responders

Change From Baseline in Serum Cortisol Levels

Change From Baseline in Plasma Adrenocorticotropic Hormone (ACTH) Levels

Change From Baseline in Mean Urinary Free Cortisol (UFC)

Percentage of Responders With Mean Urinary Free Cortisol (UFC) Within Normal Limits

Number of Participants Who Had At Least One Adverse Event (AE)

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference

Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)

Percent Change From Baseline in Serum Cortisol

Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides

Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group

Time to First UFC Response

Change From Baseline in mUFC

Change From Baseline in Tumor Volume

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score

Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L and Normalization of IGF-1 After Crossover

Percentage of Participants With a Reduction of Mean GH Level to <2.5 μg/L and the Normalization of IGF-1

Percentage of Participants With Normalization of IGF-1

Pasireotide Trough Concentrations by Incident Dose

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L

Percentage of Participants With a Reduction of Mean GH Level to < 2.5μg/L After Crossover

Percentage of Participants With Normalization of IGF-1

Change From Extension Baseline in Tumor Volume After Crossover

Percentage of Participants With Normalization of IGF-1 After Crossover

Ring Size

Ring Size After Crossover

Ring Size After Crossover

Severity Scores of Acromegaly Symptoms

Severity Scores of Acromegaly Symptoms After Crossover

Summary of Mean GH Values

Summary of Mean GH Values After Crossover

Intervention	score on a scale (Mean)
	month 3 (n=66,65)	month 6 (n=56,55)	month 12 (n=38,37)	month 18 (n=6,6)	month 24 (n=0,1)
Pasireotide 600 ug	-4.6	-4.6	-4.6	-1.3	NA
Pasireotide 900 ug	-1.9	-5.5	-5.2	-7.8	-12.0

Intervention	Percentage of body fat (Mean)
	Month 3 (n=2,2)	Month 6 (n=39,32)	Month 12 (n=29,22)	Month 24 (n=13,14)	Month 36 (n=5,8)	Month 48 (n=4,7)	Month 60 (n=4,6)
Pasireotide 600 ug	2.9	-0.4	-3.0	-1.9	-2.0	-2.0	-2.8
Pasireotide 900 ug	0.3	-0.9	-1.6	-1.9	-1.1	0.1	-0.5

Intervention	kg/m^2 (Mean)
	month 3 (n=70,67)	month 6 (n=59,57)	month 12 (n=40,39)	month 24 (n=18,23)	month 36 (n=10,13)	month 48 (n=9,10)	month 60 (n=8,8)
Pasireotide 600 ug	-1.0	-1.2	-2.1	-3.4	-2.9	-3.1	-2.8
Pasireotide 900 ug	-1.4	-2.1	-2.8	-3.0	-3.3	-2.4	-2.0

Intervention	score on a scale (Mean)
	month 3 (n=52,50)	month 6 (n=44,47)	month 12 (n=30,35)	month 24 (n=12,22)	month 36 (n=7,12)	month 48 (n=6,10)	month 60 (n=5,8)
Pasireotide 600 ug	-1.3	-0.9	-1.3	-2.8	-3.7	-6.0	-5.0
Pasireotide 900 ug	-1.3	-2.4	-3.5	-4.0	-3.2	-2.5	-2.9

Intervention	mmHg (Mean)
	Sitting SBP, month 3 (n=70,67)	Sitting SBP, month 6 (n=59,57)	Sitting SBP, month 12 (n=39,39)	Sitting SBP, month 24 (n=18,23)	Sitting SBP, month 36 (n=10,13)	Sitting SBP, month 48 (n=9,10)	Sitting SBP, month 60 (n=7,8)	Sitting DBP, month 3 (n=70,67)	Sitting DBP , month 6 (n=59,57)	Sitting DBP, month 12 (n=39,39)	Sitting DBP, month 24 (n=18,23)	Sitting DBP, month 36 (n=10,13)	Sitting DBP, month 48 (n=9,10)	Sitting DBP, month 60 (n=7,8)
Pasireotide 600 ug	-7.4	-6.8	-2.8	-11.6	-3.0	-12.0	-12.8	-3.3	-4.2	-2.0	-8.1	-6.8	-11.7	-9.1
Pasireotide 900 ug	-9.9	-11.4	-9.4	-11.0	-11.5	-3.6	-2.0	-4.1	-5.0	-5.4	-6.4	-7.3	-1.0	0.7

Intervention	Percentage of participants (Number)
	Month 3	Month 6	Month 9	Month 12	Month 16	Month 19	Month 22	Month 25
Octreotide LAR (Core & Extension)	21.4	19.8	23.1	17.6	12.4	13.7	16.3	13.7
Pasireotide LAR (Core & Extension)	30.1	30.1	27.8	29.0	25.2	23.1	25.2	24.5

Intervention	Percentage of participants (Number)
	M3 after crossover	M6 after crossover	M9 after crossover	M12 after crossover
Crossed Over to Octreotide LAR (Extension)	2.6	2.6	5.3	0.0
Crossed Over to Pasireotide LAR (Extension)	17.3	21.0	22.2	17.3

Intervention	Percentage of Participants (Number)
	Overall	Post Surgery	De novo
Octreotide LAR (Core)	19.2	21.8	17.3
Pasireotide LAR (Core)	31.3	39.4	25.7

Intervention	ng/mL (Mean)
	M4	M5	M6	M7	M8	M9	M10	M11	M12
Pasireotide LAR 60mg	13.48	13.42	13.08	14.76	15.88	16.03	16.01	16.31	16.16

Intervention	Percentage of participants (Number)
	M3	M6	M9	M12	M16	M19	M22	M25
Octreotide LAR (Core & Extension)	43.4	47.8	46.2	47.3	22.2	21.6	22.2	24.2
Pasireotide LAR (Core & Extension)	49.4	45.5	42.6	43.2	33.3	36.7	35.4	35.4