Phase 1b Study of Indibulin in Combination With Capecitabine in Advanced Solid Tumors

StatusTerminated
PhasePhase 1
Started

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Record History

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  1. Notable Reclassified as terminated (was completed) Sponsor's reason: No dose-limiting toxicity was observed. The sponsor concluded the study after 3 subjects at the higher dose level; the optional 10-subject expansion cohort was not enrolled.v6 Show 4 more changesShow less
    • Phase: Phase 1/2 to Phase 1
    • Primary completion date: Jun 11, 2009 to Sep 29, 2009
    • Study completion date: Jun 11, 2010 to Sep 29, 2009
    • Start date: Jun 2008 to Jun 19, 2008
  2. Minor Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of Jun 2013 to Jun 11, 2009
    • Study completion date changed from estimate of Jun 2013 to Jun 11, 2010
    v5
  3. Notable Primary and study completion dates: Feb 2009 to Jun 2013
    • Trial status: Completed to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 7
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Minor Trial status: Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 2008 to Feb 2009
    • Study sites revised (3)
    v2
  6. 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.
This is a phase 1b study of Indibulin in combination with Capecitabine in advanced solid tumors.
Trial Details
NCT Number NCT00726687
Lead Sponsor Alaunos Therapeutics
Conditions
(from sponsor)
Advanced Solid Tumors
Related terms Neoplasms
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov