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A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Carcinoid Tumor, Malignant Carcinoid Syndrome

Thank you

Trial Information

A Randomized, Double-blind Placebo-controlled, Multicenter Phase III Study in Patients With Advanced Carcinoid Tumor Receiving Octreotide Depot and Everolimus 10 mg/Day or Octreotide Depot and Placebo

Inclusion Criteria


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 magnetic
resonance imaging (MRI).

Exclusion criteria:

- Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma,
adenocarcinoid, goblet cell carcinoma, or small cell carcinoma.

- Hepatic artery embolization within the last 6 months or cryoablation of hepatic
metastasis within 2 months of enrollment.

- Previous treatment with mammalian target of rapamycin (mTOR) inhibitors (sirolimus,
temsirolimus, everolimus)

- Intolerance or hypersensitivity to octreotide, everolimus, or other rapamycins.

- Severe or uncontrolled medical conditions

- Chronic treatment with corticosteroids or other immunosuppressive agent.

- Other primary cancer within 3 years.

Other protocol-defined inclusion/exclusion criteria applied

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review

Outcome Description:

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.

Outcome Time Frame:

Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2325

NCT ID:

NCT00412061

Start Date:

December 2006

Completion Date:

June 2017

Related Keywords:

  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Cancer
  • Carcinoid
  • Tumor
  • Neuroendocrine
  • Carcinoma
  • Everolimus
  • Octreotide
  • Carcinoid Tumor
  • Malignant Carcinoid Syndrome
  • Serotonin Syndrome

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