Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Octreotide Long Acting Release · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion criteria: 1. Providing a written informed consent 2. Age between 18 and 80 years; 3. Histological diagnosis of colorectal cancer, presence of metastatic disease and no prior systemic therapy for metastatic disease (prior adjuvant therapy will be allowed if completed 6 months or longer bef...
Octreotide Long Acting Release is used for chemotherapy-induced diarrhea, a gastrointestinal condition. It is being developed as a treatment to prevent diarrhea caused by chemotherapy. The drug is currently in Phase 3 clinical development and is considered investigational, meaning it has not yet been approved for this use.
Octreotide Long Acting Release is developed by Novartis AG, a pharmaceutical company traded on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical trials to evaluate the drug's effectiveness in treating chemotherapy-induced diarrhea.
Octreotide Long Acting Release is in Phase 3 clinical development for chemotherapy-induced diarrhea. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trial has been completed, but the drug remains in clinical development.
Octreotide Long Acting Release has one completed Phase 3 clinical trial registered under NCT00582426. The trial, titled 'Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea,' enrolled 139 participants in Brazil. The study was randomized and controlled, and it included adults aged 18 years and older.
Yes, Octreotide Long Acting Release is also known as Octreotide LAR. The clinical trial NCT00582426 refers to the drug as Octreotide LAR, which is a long-acting release formulation of octreotide. This alternative name is used in the context of the Phase 3 study for chemotherapy-induced diarrhea.