RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer

StatusTerminated
PhasePhase 1
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 3 versions Re-verified since Oct 11, 2023, no change to tracked fieldsv25-v27
  2. Start date: Nov 2005 to Nov 1, 2005v24
  3. Interventions: Docetaxel (Drug), RAD001 (Drug) to Dexamethasone (Drug), Docetaxel (Drug), RAD001 (Drug)v23
  4. Phase: Phase 1/2 to Phase 1
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 7 words
    v22
  5. Study completion date: Apr 2012
    • Eligibility criteria expanded, about 10 words
    v21
Show 19 earlier versionsHide 19 earlier versions
  1. Trial status: Active, Not Recruiting to Terminated Sponsor's reason: Toxicity and Lack of Efficacy
    • Enrollment target: estimated 65 to confirmed 15
    • Primary completion date changed from estimate of Nov 2012 to Apr 2012
    v20
  2. Re-verified, no change to tracked fieldsv19
  3. Primary completion date: Nov 2011 to Nov 2012v18
  4. Primary completion date: Nov 2010 to Nov 2011v17
  5. Study site revisedv16
  6. Primary completion date: Nov 2009 to Nov 2010
    • Primary endpoint revised
    v15
  7. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v14
  8. Secondary endpoints shortened, about 9 words
    • Study description expanded, about 2 words
    v13
  9. Primary endpoint revised
    • Secondary endpoint revised
    • Collaborator revised
    v12
  10. Re-verified, no change to tracked fieldsv11
  11. Eligibility criteria revised
    • Study description shortened, about 1 word
    v10
  12. Primary completion date: Nov 2008 to Nov 2009
    • Study completion date: Nov 2008 to not stated
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 39 words
    v9
  13. Re-verified, no change to tracked fieldsv8
  14. Primary endpoint revised
    • Study title shortened, about 3 words
    v7
  15. Primary and study completion dates: Nov 2008
    • Eligibility criteria expanded, about 27 words
    • Study arms: 0 to 1
    v6
  16. Re-verified, no change to tracked fieldsv5
  17. Study completion date: Apr 2006 to not stated
    • Eligibility criteria expanded, about 231 words
    • Study description expanded, about 548 words
    • Study title shortened, about 5 words
    v4
  18. Eligibility criteria expanded, about 104 wordsv3
  19. Study completion date: Apr 2006
    • Eligibility criteria revised
    • Site contact updated
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
Primary: * To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for standard docetaxel treatment (phase I). * To characterize the pharmacokinetics of RAD001 and docetaxel when co-administered (phase I). Secondary: * To determine the phosphorylation status of the components of the mTOR signaling pathway and the expression of modifiers of apoptosis in the primary breast tumors, in order to determine whether these markers can be used as predictors of sensitivity to the combination of RAD001 and docetaxel * To determine the effect of the combination of RAD001 and docetaxel 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
Trial Details
NCT Number NCT00253318
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: Novartis Pharmaceuticals
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Neoplasm Metastasis
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov