A Study of Palifosfamide Tris Plus Doxorubicin Versus Doxorubicin in Unresectable or Metastatic Soft-tissue Sarcoma

Study acronym: PICASSO
StatusTerminated
PhasePhase 2
Started

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Record History

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  1. Re-verified, no change to tracked fieldsv18
  2. Reclassified as terminated (was completed) Sponsor's reason: Sponsor stopped enrollment at 67 of about 100 planned participants after an unplanned interim analysis confirmed the primary PFS endpoint had been reached. Enrolled participants were followed to their PFS endpoint.
    • Interventions: Doxorubicin (Drug), Palifosfamide Tris and Doxorubicin (Drug) to Doxorubicin (Drug), Palifosfamide-Tris (Drug)
    v17
  3. Trial status: Completed to Terminated
    • Sponsor's reason: Sponsor stopped enrollment at 67 of about 100 planned participants after an unplanned interim analysis confirmed the primary PFS endpoint…
    • Study completion date: Sep 20, 2011 to Sep 20, 2010
    v16
  4. Primary completion date: Apr 2012 to Sep 20, 2010v15 Show 4 more changesShow less
    • Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Apr 2014 to Sep 20, 2011
    • Start date: Aug 2008 to Sep 3, 2008
    • Study sites revised (23)
  5. Primary completion date: Dec 2009 to Apr 2012
    • Study completion date: Dec 2013 to Apr 2014
    v14
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  1. Study completion date: Sep 2013 to Dec 2013v13
  2. Study completion date: Sep 2012 to Sep 2013v12
  3. Enrollment target: estimated 100 to confirmed 67
    • Study completion date: Jun 2012 to Sep 2012
    v11
  4. Primary completion date changed from estimate of Jun 2010 to Dec 2009
    • Study completion date: Jun 2012
    v10
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (23)
    v9
  6. Study sites: 10 to 23v8
  7. Study sites: 8 to 10v7
  8. Study sites: 6 to 8v6
  9. Re-verified, no change to tracked fieldsv5
  10. Study sites: 1 to 6v4
  11. Re-verified, no change to tracked fieldsv3
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date: Sep 2008 to Aug 2008
    • Study title shortened, about 8 words
    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.
Alaunos Therapeutics
18 trials monitored
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Sarcoma
1,029 trials monitored
See 72 trials at risk
This is a randomized, controlled trial to evaluate the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin administered in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma (STS). Subjects who meet the entry criteria will be randomized into 1 of 2 arms: either to receive palifosfamide tris plus doxorubicin or treatment with single-agent doxorubicin. Subjects will be anthracyclin naïve.
Trial Details
NCT Number NCT00718484
Lead Sponsor Alaunos Therapeutics
Conditions
(from sponsor)		 Soft Tissue Sarcoma
Related terms Sarcoma
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov