RAD001 in Recurrent Endometrial Cancer Patients

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. 3 versions Re-verified since Oct 11, 2023, no change to tracked fieldsv20-v22
  2. Results first posted: Feb 5, 2016
    • Primary endpoints: 1 to 2
    • Study completion date: Jan 2015
    v19
  3. Primary endpoint revisedv18 Show 5 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Jun 2015 to Jan 2015
    • Secondary endpoints shortened, about 9 words
    • Study site revised
    • Eligibility criteria expanded, about 4 words
  4. Primary completion date: Jun 2014 to Jun 2015v17
  5. Primary completion date: Jun 2013 to Jun 2014
    • Eligibility criteria revised
    v16
Show 14 earlier versionsHide 14 earlier versions
  1. Re-verified, no change to tracked fieldsv15
  2. Eligibility criteria revised
    • Study description shortened, about 2 words
    v14
  3. Primary completion date: Jun 2012 to Jun 2013v13
  4. Primary completion date: Jun 2011 to Jun 2012v12
  5. Re-verified, no change to tracked fieldsv11
  6. Primary completion date: Dec 2008 to Jun 2011
    • Study site revised
    v10
  7. Primary completion date: Jun 2008 to Dec 2008v9
  8. Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Study description shortened, about 9 words
    • Site details revised
    v8
  9. Primary completion date: Jun 2008
    • Eligibility criteria revised
    • Study arms: 0 to 1
    v7
  10. Re-verified, no change to tracked fieldsv6
  11. Eligibility criteria revisedv5 Show 4 more changesShow less
    • Study description expanded, about 416 words
    • Study site revised
    • Collaborators shortened, about 1 word
    • Study title expanded, about 1 word
  12. 2 versions Re-verified since May 5, 2006, no change to tracked fieldsv3-v4
  13. Eligibility criteria shortened, about 1 wordv2
  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.
The goal of this clinical research study is to learn if RAD001 can shrink or slow the growth of tumors in patients who have recurrent endometrial cancer. The safety of this drug will also be studied. Objectives: Primary Objective: 1\. To determine the efficacy of RAD001 in patients with progressive or recurrent endometrial cancer. Secondary Objective: 1. To determine the nature and degree of toxicity of RAD001 in this cohort of patients. 2. To characterize, in pre- and post- treatment tumor samples, when available, expression levels of total and phosphorylated mTOR (mammalian "target of rapamycin") as well as relevant upstream and downstream signaling components (optional).
Trial Details
NCT Number NCT00087685
Lead Sponsor M.D. Anderson Cancer Center
Conditions
(from sponsor)		 Endometrial Cancer
Related terms Endometrial Neoplasms, Uterine Neoplasms
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov