Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 LAR, Sandostatin LAR
Octreotide Long Acting Release · 6 trials · 8 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.
The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of \<4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
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. |
| Octreotide Long Acting Release | EXPERIMENTAL | Prevention of Chemotherapy Induced Diarrhea (CID) |
| Standard Treatment | OTHER | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
| 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 Long Acting Release | DRUG | Patients will receive the first dose of Octreotide LAR (30 mg) at chemotherapy initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR (with an interval of 28 days between them), until first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first. |
| Standard Treatment | OTHER | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
| 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 Long Acting Release is an injectable somatostatin analog developed by Novartis AG (ticker NVS). It is being studied in Phase 3 clinical development for chemotherapy-induced diarrhea, a gastrointestinal condition in which cancer treatment causes frequent loose stools. The long acting release formulation is designed to provide sustained drug exposure after administration.
Octreotide Long Acting Release is being evaluated for the prevention of chemotherapy-induced diarrhea in adults aged 18 years and older. A completed Phase 3 trial, NCT00582426, studied the drug for this indication in Brazil with 139 enrolled patients. It remains an investigational use rather than an established approved indication.
Octreotide Long Acting Release is an agonist that binds somatostatin receptors, specifically SSTR1, SSTR2, SSTR3, SSTR4, and SSTR5. Its highest affinity is for SSTR2 and SSTR5. Activation of these receptors reduces secretion and smooth muscle activity in the gastrointestinal tract, which is the basis for its study in chemotherapy-induced diarrhea.
Novartis AG, which trades under the ticker NVS, is the developer of Octreotide Long Acting Release. The company is responsible for the clinical program evaluating the drug in chemotherapy-induced diarrhea.
Octreotide Long Acting Release is in Phase 3 clinical development for chemotherapy-induced diarrhea. The program includes one completed Phase 3 trial, and no trials are currently listed as active. The drug is investigational for this indication and has not been established as approved for chemotherapy-induced diarrhea.
Octreotide Long Acting Release has been studied in the Phase 3 trial NCT00582426, titled Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea. The trial enrolled 139 adults aged 18 years and older in Brazil, used a controlled and randomized design, and has been completed.