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 SOM230, Sandostatin® LAR, SMS995, Octreotide Long Acting Release
Octreotide LAR · 10 trials · 12 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.
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
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.
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 |
|---|---|---|
| [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 | - |
| SOM230 | EXPERIMENTAL | Subjects with dumping syndrome treated with pasireotide |
| 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. |
| 1 | EXPERIMENTAL | - |
| 2 | PLACEBO_COMPARATOR | - |
| 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. |
| 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 |
| 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 |
| SMS995 | DRUG | - |
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 a long-acting repeatable formulation of octreotide, a small molecule somatostatin receptor agonist developed by Novartis AG (ticker NVS). It is studied in acromegaly, peritoneal neoplasms, prostate cancer, and somatostatin receptor positive (SSTR+) conditions. It is an investigational and clinical-stage product rather than a newly approved agent.
Octreotide LAR targets the somatostatin receptors SSTR1, SSTR2, SSTR3, SSTR4, and SSTR5, acting as an agonist at these receptors. Its binding profile spans all five receptor subtypes, which underlies its use in somatostatin receptor positive (SSTR+) settings and in acromegaly, where somatostatin receptor signaling is central.
Octreotide LAR is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor associated with the clinical development program for this long-acting repeatable octreotide formulation across endocrine and oncology indications.
Octreotide LAR is in Phase 3 clinical development. Its program includes Phase 3 and Phase 2 studies, and it is not described as approved. The Phase 3 work covers acromegaly and somatostatin receptor positive (SSTR+) gastroenteropancreatic neuroendocrine tumor settings.
Octreotide LAR has been studied in several trials, including NCT06784752, a recruiting Phase 3 study in SSTR+ gastroenteropancreatic neuroendocrine tumors with 240 patients across multiple countries. Completed studies include NCT00332696 in peritoneal carcinomatosis, NCT00225979 in treatment-naive acromegaly, and NCT00166725 in advanced prostate cancer.