CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
RAD001 +1 moredrug
Likely dose
RAD001 5–10 mg orally daily plus octreotide depot 30 mg IM every 28 (±7) daysAI-extracted
Key inclusion· 6
  • ✓Histologically confirmed low-grade neuroendocrine carcinoma (carcinoid at any site or islet cell/pancreatic endocrine tumor); atypical/intermediate grade carcinoid allowed
  • ✓Metastatic or unresectable local-regional disease
  • ✓Measurable disease by RECIST criteria
  • ✓Age ≥18 years
Key exclusion· 7
  • ✕Concurrent chemotherapy, immunotherapy, or radiotherapy
  • ✕Intolerance to octreotide
  • ✕Chemotherapy, immunotherapy, or investigational therapy within 30 days prior to registration
  • ✕Uncontrolled diabetes mellitus (fasting blood sugar >1.5× ULN)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00113360
NCT00113360Phase 2Completed
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Phase II Study of RAD001 Plus Octreotide Depot in Patients With Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma (Carcinoid, Islet Cell)

M.D. Anderson Cancer Center·interventional·Posted Jun 8, 2005·Updated May 1, 2025

In Brief

A Phase 2 clinical trial evaluating RAD001 and Octreotide Depot for Neuroendocrine Carcinoma and Islet Cell Carcinoma. Completed, enrolled 67 participants across 1 site.

Detailed Summary

Objectives: Primary endpoint: -Assess the clinical activity of RAD 001 plus depot octreotide as defined by progression free survival (PFS) duration defined by RECIST criteria in treated and untreated patients with metastatic, unresectable low grade neuroendocrine carcinoma. Secondary endpoints: * Assess the progression free survival duration of patients with metastatic, unresectable low grade neuroendocrine carcinoma treated with RAD 001 plus depot octreotide. * Assess the safety of RAD 001 plus depot octreotide in patients with metastatic, unresectable low grade neuroendocrine carcinoma. * To determine the expression/phosphorylation status of the components of the mTOR signaling pathway in the primary tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and octreotide. * To determine the effect of the combination of RAD001 and octreotide on the expression and phosphorylation of mTOR's targets in the accessible tumor tissue, in order to identify potential pharmacodynamics markers of response to this drug combination. * To observe the effects of treatment with RAD001 on plasma angiogenic biomarkers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroendocrine Carcinoma, Islet Cell Carcinoma
CountriesUnited States
CollaboratorsNovartis Pharmaceuticals

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2005
Enrollment StartJan 1, 2005
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 21.1 years ago

Interventions

RAD001drug

Starting dose of 5 or 10 mg by mouth daily.

Octreotide Depotdrug

30 mg injection into the muscle of either buttock once every 28 (±7) days.