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RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer

StatusTerminated
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  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 wordsv22 Show 2 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  5. Completion date: Apr 2012 Eligibility criteria expanded, about 10 wordsv21 Show 1 more changeShow less
    • Eligibility criteria expanded, about 10 words

    See this version in full on ClinicalTrials.gov ↗

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 2012v20 Show 2 more changesShow less
    • Enrollment target: estimated 65 to confirmed 15
    • Primary completion date changed from estimate of Nov 2012 to Apr 2012
  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 See this version in full on ClinicalTrials.gov ↗
  6. Primary completion date: Nov 2009 to Nov 2010 Primary endpoint revisedv15 Show 1 more changeShow less
    • Primary endpoint revised

    See this version in full on ClinicalTrials.gov ↗

  7. Trial status: Recruiting to Active, Not Recruiting Site details revisedv14 Show 1 more changeShow less
    • Site details revised
  8. Secondary endpoints shortened, about 9 words Study description expanded, about 2 wordsv13 Show 1 more changeShow less
    • Study description expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  9. Primary endpoint revised Secondary endpoint revised · Collaborator revisedv12 Show 2 more changesShow less
    • Secondary endpoint revised
    • Collaborator revised

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  10. Re-verified, no change to tracked fieldsv11
  11. Eligibility criteria revised Study description shortened, about 1 wordv10 Show 1 more changeShow less
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  12. Primary completion date: Nov 2008 to Nov 2009 Completion date: Nov 2008 to not stated · Secondary endpoints: details revised at 1 of 1 entry · Study description shortened, about 39 wordsv9 Show 3 more changesShow less
    • Completion date: Nov 2008 to not stated
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description shortened, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  13. Re-verified, no change to tracked fieldsv8
  14. Primary endpoint revised Study title shortened, about 3 wordsv7 Show 1 more changeShow less
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  15. Primary and study completion dates: Nov 2008 Eligibility criteria expanded, about 27 words · Study arms: 0 to 1v6 Show 2 more changesShow less
    • Eligibility criteria expanded, about 27 words
    • Study arms: 0 to 1

    See this version in full on ClinicalTrials.gov ↗

  16. Re-verified, no change to tracked fieldsv5
  17. Completion date: Apr 2006 to not stated Eligibility criteria expanded, about 231 words · Study description expanded, about 548 words · Study title shortened, about 5 wordsv4 Show 3 more changesShow less
    • Eligibility criteria expanded, about 231 words
    • Study description expanded, about 548 words
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  18. Eligibility criteria expanded, about 104 wordsv3 See this version in full on ClinicalTrials.gov ↗
  19. Completion date: Apr 2006 Eligibility criteria revised · Site contact updatedv2 Show 2 more changesShow less
    • Eligibility criteria revised
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  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 Breast Cancer
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov