| Signifor LAR (pasireotide long acting release) / Recordati |
NCT01794793 / 2013-000267-84: Study to Allow Access to Pasireotide for Patients Benefiting From Pasireotide Treatment in Novartis-sponsored Studies |
|
|
| Completed | 4 | 337 | Europe, Canada, Japan, US, RoW | Pasireotide, SOM230; Signifor, Cabergoline, dostinex, Pasireotide LAR | RECORDATI GROUP | Cushing's Disease, Acromegaly, Neuroendocrine Tumors, Pituitary Tumors, Ectopic ACTH Secreting (EAS) Tumors, Dumping Syndrome, Prostate Cancer, Melanoma Negative for bRAF, Melanoma Negative for nRAS | 07/23 | 07/23 | | |
ACTRN12615001328561: Phase II study evaluating the efficacy of Pasireotide long-acting release (LAR; SOM230) dose escalation in patients with refractory non-functional gastroenteropancreatic neuroendocrine tumors (GEP NETs). |
|
|
| Not yet recruiting | 2 | 30 | | | Peter MacCallum Cancer Centre, Novartis Pty Ltd | Gastro-entero-pancreatic neuroendocrine tumours | | | | |
2010-018795-24: Evaluation of the effect of pasireotide LAR administration in the lymphocele prevention after axillary node dissection for breast cancer |
|
|
| Ongoing | 2 | 90 | Europe | PASIREOTIDE LAR, SOM 230 C, | Alliance pour la recherche en cancérologie | BREAST CANCER | | | | |
NCT01253161: Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs) |
|
|
| Completed | 2 | 29 | US | Pasireotide Long Acting Release (LAR), SOM 230 | H. Lee Moffitt Cancer Center and Research Institute, Novartis Pharmaceuticals, RECORDATI GROUP | Neuroendocrine Tumors, Carcinoid Tumors | 10/21 | 03/23 | | |
| Signifor (pasireotide) / Recordati |
| Active, not recruiting | 4 | 126 | Europe | Hydrocortisone, Pasireotide | Helsinki University Central Hospital | Pancreatic Fistula, Pancreatic Neoplasms | 01/19 | 12/29 | | |
| Active, not recruiting | 3 | 226 | Europe, Canada, US, RoW | Lutathera, AAA601, 30 mg Octreotide long acting repeatable (LAR) (Sandostatin LAR Depot), SOM230, 2.5% Lys-Arg sterile amino acid solution, High dose 60 mg octreotide long-acting repeatable | Advanced Accelerator Applications | Gastro-enteropancreatic Neuroendocrine Tumor | 07/23 | 10/27 | | |
NCT06784752: Study to Evaluate the Efficacy and Safety of [^177Lu]Lu-DOTA-TATE in Patients With Grade 1 and Grade 2 Advanced GEP-NET |
|
|
| Not yet recruiting | 3 | 240 | NA | [^177Lu]Lu-DOTA-TATE, Octreotide LAR, SOM230 | Novartis Pharmaceuticals | Somatostatin Receptor Positive (SSTR+), Gastroenteropancreatic Neuroendocrine Tumor (GEP-NET) | 06/28 | 07/32 | | |
2006-004080-55: Stepwise Medical Treatment of Cushing’s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole |
|
|
| Ongoing | 2 | 16 | Europe | SOM230, Dostinex, Ketoconazole, SOM230B, Dostinex, Nizoral, Dostinex, Nizoral | Erasmus MC | The medical condition to be investigated is Cushing\'s disease which is caused by an ACTH producing pituitary adenoma | | | | |
2012-003939-27: Objective evaluation of the effects of pasireotide on gastrointestinal and colorectal transit times, rectal wall properties, and postprandial response in patients with carcinoid diarrhea Undersøgelse af pasireotids effekt på transittiden gennem tarmen, endetarmens egenskaber samt respons efter fødeindtag hos patienter med diare grundet en neuroendokrin tumor |
|
|
| Ongoing | 2 | 15 | Europe | Signifor 0.6 mg s.c., Signifor 0.6 mg s.c. | Klaus Krogh, Novartis, Aarhus University | Patients with neuroendocrine tumors and carcinoid diarrhea | | | | |
2019-002507-18: 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 Evaluation de la faisabilité et de l’efficacité d’un traitement par pasireotide dans la réduction du taux de fistules digestives sévères après chirurgie de cytoréduction complète suivie de chimio-hyperthermie intra-péritonéale pour carcinose péritonéale |
|
|
| Not yet recruiting | 2 | 217 | Europe | Pasireotide, Solution for injection, Signifor 0.9mg solution for injection | Gustave Roussy, PHRC | Primary and secondary peritoneal malignancies Tumeurs primaires et secondaires du péritoine, peritoneal malignancies Tumeurs du péritoine, Diseases [C] - Cancer [C04] | | | | |
PASIREOCHIP, NCT04826432 / 2019-002507-18: Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis |
|
|
| Terminated | 2 | 6 | Europe | Pasireotide 0.9 MG/ML, Saline water | Gustave Roussy, Cancer Campus, Grand Paris, PHRC | Peritoneal Carcinomatosis | 02/24 | 02/24 | | |
NCT06295952: A Study of Pasireotide in People With Prolactinoma |
|
|
| Recruiting | 2 | 10 | US | Pasireotide, SF-36 and HADS | Memorial Sloan Kettering Cancer Center, Recordati Pharmaceutical company | Prolactin-Producing Pituitary Tumor | 02/27 | 02/27 | | |
PAMSARC, NCT06456359: Pasireotide as Maintenance Treatment in Synovial Sarcoma and Desmoplastic Small Round Cell Tumor |
|
|
| Recruiting | 2 | 28 | Europe | Signifor, ATC-Code: H01CB05 | University Hospital Heidelberg | Desmoplastic Small Round Cell Tumor, Synovial Sarcoma | 10/27 | 10/28 | | |
| Recruiting | 2 | 72 | Europe, US | Pasireotide Diaspartate, Pasireotide | RECORDATI GROUP | Post-Bariatric Hypoglycemia | 04/25 | 04/26 | | |
NCT02835131: Compassionate Use of SOM230 for Hyperinsulinemic/Hypoglycemia |
|
|
| No Longer Available | N/A | | US | Pasireotide, Signifor, SOM230 | Montefiore Medical Center | Congenital Hyperinsulinism | | | | |
NCT02310269: Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease |
|
|
| Completed | N/A | 152 | Europe, Canada, US, RoW | Pasireotide, Signifor | RECORDATI GROUP | Cushings Disease | 07/23 | 07/23 | | |
RAPSODIA, NCT06597383: The RApid Switch From 1st Generation Somatostatin Analogues to PaSireOtiDe In Acromegaly |
|
|
| Recruiting | N/A | 100 | Europe | | IRCCS San Raffaele, University of Turin, Italy, University of Padova, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Acromegaly | 11/24 | 11/24 | | |
| Actinium-225 DOTATATE (RYZ101) / BMS |
2022-000507-12: A randomized, controlled, open-label study of RYZ101 compared with standard of care therapy in subjects with inoperable, advanced, SSTR+ well-differentiated GEP-NET that has progressed following 177Lu SSA therapy Ensayo aleatorizado, controlado y abierto de RYZ101 frente al tratamiento habitual en sujetos con tumores neuroendocrinos gastroenteropancreáticos bien diferenciados SSTR+, avanzados e inoperables, que hayan progresado tras tratamiento con 177Lu SSA. |
|
|
| Not yet recruiting | 3 | 288 | Europe | RYZ101, Sunitinib, RYZ101, Sunitinib, L01XE04, Solution for injection, Tablet, Capsule, hard, Powder and solvent for suspension for injection, Solution for injection in pre-filled syringe, Everolimus Zentiva 5mg Tabletten, Szunitinib Mylan 12,5 mg, Sandostatin® LAR®- Monatsdepot 30 mg powder and solvent for suspension for injection, SOMATULINE AUTOGEL 120 mg solution for injection in a pre-filled syringe, Szunitinib Sandoz 12,5 mg | RayzeBio, Inc., RayzeBio, Inc. | gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) Tumores neuroendocrinos gastroenteropancreáticos, gastro-enteropancreatic neuroendocrine tumors (GEP-NETs) Tumores neuroendocrinos gastroenteropancreáticos, Diseases [C] - Cancer [C04] | | | | |
| Recruiting | 3 | 288 | Europe, Canada, US, RoW | RYZ101, Everolimus, Sunitinib, Octreotide, Lanreotide | RayzeBio, Inc., RayzeBio, Inc. | GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease, Neuroendocrine Tumors, Carcinoid, Carcinoid Tumor, Pancreatic NET | 12/25 | 07/28 | | |
TRACY-1, NCT06590857: Trial of 225Ac-DOTATATE (RYZ101) in Subjects with ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs. |
|
|
| Recruiting | 1/2 | 124 | US | RYZ101 | RayzeBio, Inc. | Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer | 10/28 | 01/33 | | |
NCT05595460: Study of RYZ101 in Combination With SoC in Subjects With SSTR+ ES-SCLC |
|
|
| Recruiting | 1 | 31 | US | RYZ101 Dose Level 1, RYZ101 Dose Level 2, RYZ101 Dose Level 3, RYZ101 Dose Level -1, Atezolizumab, Carboplatin, Etoposide | RayzeBio, Inc. | SCLC,Extensive Stage | 03/25 | 12/26 | | |
AcTRESS, NCT06411301: A Phase I Study to Assess the Tolerability of 225Ac-DOTATATE in Patients with Refractory and Relapsing Multiple Myeloma Expressing Somatostatin Receptors |
|
|
| Withdrawn | 1 | 30 | Europe | 225Ac-DOTATATE, RYZ101 | Jules Bordet Institute, RayzeBio, Inc. | Multiple Myeloma, Refractory, Multiple Myeloma in Relapse, Multiple Myeloma Progression | 10/26 | 10/26 | | |
