RAD001 Plus Octreotide Depot in Metastatic or Unresectable Low Grade Neuroendocrine Carcinoma

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. 4 versions Re-verified since Aug 1, 2012, no change to tracked fieldsv13-v16
  2. Eligibility criteria expanded, about 4 wordsv12
  3. Results first posted: Dec 7, 2010v11 Show 8 more changesShow less
    • Primary endpoint revised
    • Trial status: Active, Not Recruiting to Completed
    • Enrollment target: estimated 60 to confirmed 67
    • Primary completion date changed from estimate of Jan 2010 to Jul 2009
    • Study completion date: Jul 2009
    • Eligibility criteria expanded, about 19 words
    • Study site revised
    • Study description expanded, about 3 words
  4. Primary completion date: Jan 2009 to Jan 2010
    • Primary endpoint revised
    • Secondary endpoints shortened, about 8 words
    v10
  5. Primary endpoint revised
    • Secondary endpoint revised
    • Study description expanded, about 454 words
    • Collaborator revised
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study Status, Conditions, Referencesv8
  2. Primary endpoint revisedv7 Show 4 more changesShow less
    • Interventions: Depot Octreotide (Drug), RAD001 (Drug) to Octreotide Depot (Drug), RAD001 (Drug)
    • Secondary endpoint revised
    • Study title revised
    • Eligibility criteria shortened, about 3 words
  3. Primary completion date: Jan 2009v6 Show 4 more changesShow less
    • Study completion date: Feb 2005 to not stated
    • Interventions: RAD001 (Drug), octreotide depot (Drug) to Depot Octreotide (Drug), RAD001 (Drug)
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study arms: 0 to 1
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  5. 2 versions Re-verified since Jun 7, 2006, no change to tracked fieldsv3-v4
  6. Enrollment target: 40 to 60
    • Primary endpoint revised
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 2 to 1
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00113360
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Novartis Pharmaceuticals
Conditions
(from sponsor)		 Neuroendocrine Carcinoma, Islet Cell Carcinoma
Related terms Carcinoma, Islet Cell, Carcinoma, Neuroendocrine
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov