Study of a Novel Indibulin Dosing Schedule for the Treatment of Metastatic Breast Cancer

StatusTerminated
PhasePhase 1
Started

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Record History

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  1. Reclassified as terminated (was completed) Sponsor's reason: Sponsor business decision: enrollment closed after the Phase 1 dose escalation, before an MTD was reached. The Phase 2 portion was not conducted.v9 Show 5 more changesShow less
    • Phase: Phase 1/2 to Phase 1
    • Enrollment target: estimated 60 to confirmed 35
    • Primary completion date: May 1, 2013 to Sep 3, 2012
    • Study completion date: Jun 1, 2014 to May 21, 2013
    • Start date: Mar 2010 to Apr 6, 2010
  2. Study completion date changed from estimate of May 2013 to Jun 1, 2014
    • Trial status: Active, Not Recruiting to Completed
    • Primary completion date changed from estimate of May 2013 to May 1, 2013
    v8
  3. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v7
  4. Eligibility criteria revisedv6
  5. Primary and study completion dates: Nov 2011 to May 2013
    • Study sites: 1 to 4
    v5
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  1. Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 6 entries
    v4
  2. 2 versions Re-verified since Mar 17, 2011, no change to tracked fieldsv2-v3
  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.
This study is a Phase I/II trial of a novel Indibulin dosing schedule for the treatment of metastatic breast cancer. Eligible patients will have measurable or non-measurable, metastatic or unresectable, locally advanced breast cancer and may have received any number of prior therapies for their disease. It is expected that the Phase I portion will enroll up to 20 patients and the Phase II portion will enroll up to 45 patients.
Trial Details
NCT Number NCT01113970
Lead Sponsor Alaunos Therapeutics
Collaborators: Memorial Sloan Kettering Cancer Center
Conditions
(from sponsor)		 Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov