A Phase-II Trial of ZIO 101 in Advanced Hepatocellular Carcinoma

StatusTerminated
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv12
  2. Notable Reclassified as terminated (was completed) Sponsor's reason: Study closed after Stage 1 (15 of 40 planned patients treated) due to lack of treatment response; criteria to proceed to Stage 2 were not met.
    • Primary and study completion dates: Aug 8, 2008 to Aug 9, 2008
    • Start date: May 7, 2007 to May 1, 2007
    v11
  3. Notable Start date: Jan 2007 to May 7, 2007
    • Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 2013 to Aug 8, 2008
    v10
  4. Minor Primary and study completion dates: Jun 2013 to Dec 2013v9
  5. Notable Primary and study completion dates: Sep 2008 to Jun 2013
    • Trial status: Completed to Active, Not Recruiting
    v8
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  1. Minor Enrollment target: estimated 60 to confirmed 15v7
  2. Minor Trial status: Active, Not Recruiting to Completed
    • Primary and study completion dates changed from estimate of Dec 2008 to Sep 2008
    v6
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (6)
    v5
  4. Minor Study sites: 5 to 6v4 Show 5 more changesShow less
    • Primary and study completion dates: Dec 2008
    • Start date: Jan 2007
    • Interventions: ZIO-101 (Drug) to Darinaparsin (Drug)
    • Eligibility criteria expanded, about 551 words
    • Study arms: 0 to 1
  5. Minor Study sites revised (5)v3
  6. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 5
    v2
  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 study of safety of a new organic arsenic compound in the treatment of advanced hepatocellular carcinoma
Trial Details
NCT Number NCT00423306
Lead Sponsor Alaunos Therapeutics
Conditions
(from sponsor)
Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov