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Octreotide · 4 trials · 5 indications
Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
Growth hormone (GH) level was the average value measured in 3 blood samples collected at 15 minute intervals at each visit. GH was measured with an automated immunometric assay in a central laboratory.
Insulin-like growth factor 1 (IGF-1) level was measured in a blood sample with an automated immunometric assay in a central laboratory.
| Arm | Type | Description |
|---|---|---|
| Octreotide+ Everolimus | EXPERIMENTAL | Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1. |
| Octreotide+ Placebo | PLACEBO_COMPARATOR | Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. |
| Octreotide 30 mg every 21 days | EXPERIMENTAL | Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor. |
| Octreotide 60 mg every 28 days | EXPERIMENTAL | Patients received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor. |
| Octreotide | EXPERIMENTAL | - |
| Sandostatin | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Octreotide | DRUG | Octreotide 30 mg intramuscularly (i.m.) every 28 days. |
| Placebo | DRUG | A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo. |
| Everolimus | DRUG | A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus. |
| Octreotide acetate 30 mg suspension | DRUG | Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose. |
Inclusion criteria: * Advanced (unresectable or metastatic) carcinoid tumor * Confirmed low-grade or intermediate-grade neuroendocrine carcinoma * Documented progression of disease within 12 months prior to randomization. * Measurable disease determined by triphasic computer tomography (CT) scan or...
Octreotide is used for advanced hepatocellular carcinoma, acromegaly, carcinoid tumor, and thymoma. It is a small molecule developed by Novartis AG for endocrine conditions. Clinical trials have evaluated its efficacy in these indications, including a Phase 3 study in advanced hepatocellular carcinoma and a Phase 3 study in uncontrolled acromegaly.
Octreotide is a somatostatin analog that targets somatostatin receptors, which are often overexpressed in neuroendocrine tumors and other conditions. By binding to these receptors, it inhibits the release of growth hormone and other hormones, helping to manage conditions like acromegaly and carcinoid tumors.
Octreotide is developed by Novartis AG, a multinational pharmaceutical company traded under the ticker NVS. Novartis has conducted multiple clinical trials of Octreotide across various indications, including advanced hepatocellular carcinoma, acromegaly, carcinoid tumor, and thymoma.
Octreotide has completed Phase 3 clinical trials for advanced hepatocellular carcinoma, acromegaly, and carcinoid tumor, as well as a Phase 2 trial for thymoma. It is an investigational drug in these settings, with all trials completed. It is not described as FDA approved in the available data.
Octreotide has been studied in several completed trials, including NCT00241020 (Phase 3, advanced hepatocellular carcinoma, 270 patients), NCT00332969 (Phase 2, thymoma, 25 patients), NCT00372697 (Phase 3, acromegaly, 28 patients), and NCT00412061 (Phase 3, carcinoid tumor, 429 patients).
Octreotide is also known as Octreotide Acetate, as seen in the trial titled 'Efficacy/Safety of Octreotide Acetate in Patients With Uncontrolled Acromegaly.' The drug is a small molecule somatostatin analog used in endocrine-related conditions such as acromegaly and carcinoid tumors.