Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Octreotide LAR · 5 trials · 7 indications
PFS is defined as the time from randomization to the first occurrence of progression (centrally assessed by Blinded Independent Review Committee (BIRC) according to RECIST v1.1) or death due to any cause.
Treatment Success was defined as: less than 2 episodes of vomiting on average per day for the 4 days prior to Day 14 \[from Day 10 to Day 13\] and no use of an Nasogastric Tube (NGT) since at least Day 10 and no use of an anticholinergic agent until Day 14. Treatment Failure is defined as: 2 or more episodes of vomiting per day on average for the 4 days prior to Day 14 or use of an NGT after Day 9 or use of an anticholinergic agent before Day 14 or withdrawal from the trial between Day 1 and Day 14 (included), whatever the cause.
| Arm | Type | Description |
|---|---|---|
| [177Lu]Lu-DOTA-TATE + Octreotide LAR | EXPERIMENTAL | Participants in this arm will receive \[177Lu\]Lu-DOTA-TATE plus Octreotide long-acting release (LAR). |
| Octreotide LAR | ACTIVE_COMPARATOR | Participants in this arm will receive Octreotide LAR only. |
| SMS995 | EXPERIMENTAL | - |
| Octreotide | EXPERIMENTAL | Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. |
| Placebo | PLACEBO_COMPARATOR | Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days. |
| Name | Type | Description |
|---|---|---|
| [177Lu]Lu-DOTA-TATE | RADIATION | \[177Lu\]Lu-DOTA-TATE will be administered 4 times during treatment period with frequency of every 8 weeks (Q8W) |
| Octreotide LAR | DRUG | Octreotide LAR will be administered Q8W when co-administered with \[177Lu\]Lu-DOTA-TATE in the investigational arm followed by Q4W. In the control arm Octreotide LAR will be administered Q4W. |
| Octreotide (Immediate release) | DRUG | Immediate-release Octreotide supplied in 100 µg/mL ampules. |
| methylprednisolone | DRUG | methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections). |
| Placebo | DRUG | Physiologic saline solution |
Inclusion Criteria: * Presence of metastasized or locally advanced, unresectable (curative intent), histologically proven, well differentiated Grade 1 or Grade 2 (Ki-67 \<10%) gastroenteropancreatic neuroendocrine tumor (GEP-NET) diagnosed within 6 months prior to screening. * Participants with hig...
Octreotide LAR is used for acromegaly, prostate cancer, and peritoneal neoplasms. It is also being studied in somatostatin receptor positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NET). The drug is a long-acting repeatable formulation of octreotide acetate for injectable suspension.
Octreotide LAR is a peptide that targets somatostatin receptors. It is being evaluated in patients with somatostatin receptor positive (SSTR+) tumors, including gastroenteropancreatic neuroendocrine tumors (GEP-NET). The drug's activity is related to its binding to these receptors.
Octreotide LAR is developed by Novartis AG, which trades under the ticker NVS. The company is conducting clinical trials of the drug across multiple indications, including acromegaly, prostate cancer, and peritoneal neoplasms.
Octreotide LAR is in Phase 3 clinical development. A Phase 3 trial is currently recruiting patients with somatostatin receptor positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NET). The drug is investigational and not yet approved for this indication.
Octreotide LAR is being studied in a Phase 3 trial with NCT number NCT06784752, which is recruiting 240 patients with SSTR+ GEP-NET. Completed trials include NCT00166725 in prostate cancer, NCT00225979 in acromegaly, and NCT00332696 in peritoneal neoplasms.
Octreotide LAR is a long-acting repeatable formulation of octreotide acetate for injectable suspension. Clinical trials reference octreotide acetate as the active substance, and Octreotide LAR is the extended-release version designed for sustained delivery.