Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SOM230 · 3 trials · 3 indications
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications as defined per study prototol. These will be evaluated according to the CTCAE v4.03.
Progression is defined as a PSA-increase of at least 25% and an absolute increase of at least 2 ng/ml from a nadir value, confirmed by a second value four weeks later.
Description: Cmax, AUCinf, AUClast, CL/F, CLR, glucose, insulin, glucagon
| Arm | Type | Description |
|---|---|---|
| SOM230 | EXPERIMENTAL | Subjects with dumping syndrome treated with pasireotide |
| Name | Type | Description |
|---|---|---|
| SOM230 | DRUG | Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg |
Inclusion criteria:. * Male or female patients ≥ 18 years of age. * Post-gastric or esophageal bypass surgery, matching one of the criteria below: * Bariatric surgery: more than 6 months before signing the informed consent * Esophageal cancer surgery: were disease free at study entry * Gastric canc...
SOM230, also known as pasireotide, is an investigational small molecule being developed by Novartis AG (NVS). It has been studied in clinical trials for conditions including dumping syndrome, castration resistant prostate cancer, and renal impairment. The drug is in clinical development and is not approved.
SOM230 has been studied for use in dumping syndrome, castration resistant prostate cancer, and renal impairment. Clinical trials have evaluated its safety, tolerability, pharmacokinetics, and preliminary efficacy in these conditions.
SOM230 is developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker NVS.
SOM230 has been studied in Phase 1 and Phase 2 clinical trials. Completed trials include a Phase 1 study in renal impairment, a Phase 2 study in dumping syndrome, and a Phase 1 study in castration resistant prostate cancer.
SOM230 has been evaluated in clinical trials including NCT01578928, a Phase 1 study in subjects with renal impairment; NCT01637272, a Phase 2 study in patients with dumping syndrome; and NCT01646684, a Phase 1 study in patients with castration resistant prostate cancer. All three trials are completed.
Yes, SOM230 is also known as pasireotide. Clinical trials for SOM230, such as NCT01578928 and NCT01637272, refer to the drug as pasireotide in their titles.