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Label indication SANDOSTATIN LAR DEPOT 10 mg, 20 mg, and 30 mg is indicated in patients in whom initial treatment with Sandostatin Injection has been shown to be effective and tolerated. SANDOSTATIN LAR DEPOT is a somatostatin analogue indicated for: Treatment in patients who have responded to and tolerated Sandostatin Injection subcutaneous injection for: Acromegaly ( 1.1 ) Severe diarrhea/flushing episodes associated with… FDA label
Also known as Octreotide (Immediate release), Sandostatin LAR® Depot
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 studied and used in acromegaly, advanced hepatocellular carcinoma, carcinoid tumor, and thymoma. It is a somatostatin analog developed by Novartis AG (ticker NVS). Clinical development has covered endocrine and oncology indications, including malignant carcinoid syndrome, with trials enrolling adults aged 18 years and older.
Octreotide targets the somatostatin receptors SSTR1, SSTR2, SSTR3, SSTR4, and SSTR5, acting as an agonist at these receptors. Binding to somatostatin receptors, particularly SSTR2 and SSTR5, underlies its activity in acromegaly and carcinoid tumor. It is a small molecule somatostatin analog.
Octreotide is developed by Novartis AG, which trades under the ticker NVS. Novartis has sponsored Phase 3 and Phase 2 clinical trials of octreotide in acromegaly, advanced hepatocellular carcinoma, carcinoid tumor, and thymoma. The drug is also known as octreotide acetate 30 mg suspension and immediate release octreotide.
Octreotide has been evaluated in Phase 3 and Phase 2 clinical trials, which are completed. It is an investigational and marketed somatostatin analog, and the trials listed in its development program have finished, with no active trials currently recorded. Its studied indications include acromegaly, advanced hepatocellular carcinoma, carcinoid tumor, and thymoma.
Octreotide has been studied in completed trials including NCT00412061, a Phase 3 trial of everolimus and octreotide in advanced carcinoid tumor with 429 patients, and NCT00241020, a Phase 3 trial in advanced hepatocellular carcinoma with 270 patients. Other trials include NCT00372697 in uncontrolled acromegaly and NCT00332969 in primary inoperable thymoma.