Alaunos Therapeutics trial of palifosfamide plus doxorubicin in sarcoma ended early after interim an
The phase 2 PICASSO study stopped enrollment at 67 of a planned 100 patients after an interim look showed the primary progression-free survival endpoint had been met.
A phase 2 study testing palifosfamide tris combined with doxorubicin against doxorubicin alone in unresectable or metastatic soft tissue sarcoma was terminated, according to its ClinicalTrials.gov record (NCT00718484, sponsor ID IPM2002, acronym PICASSO). Participants already enrolled were followed to their PFS endpoint.1
The trial is listed under lead sponsor Alaunos Therapeutics in the record's sponsor field.
Eligible subjects were randomized to receive either palifosfamide tris plus doxorubicin or single-agent doxorubicin.1 All subjects were required to be anthracyclin naïve.1
In the experimental arm, 150 mg/m2 IV palifosfamide tris and 75 mg/m2 IV doxorubicin were given on Day 1 of each 21-day cycle, with doxorubicin started about 60 minutes after palifosfamide tris, and palifosfamide tris alone continued on Days 2 and 31. In the comparator arm, 75 mg/m2 doxorubicin was given IV on Day 1 of each cycle.1
The study began on September 3, 2008, and both primary and study completion were recorded as September 20, 2010. The record was first posted July 18, 2008, and the last update posted is dated September 30, 2026, per the registry listing.
Fact check notes
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The sponsor stopped enrollment at 67 of about 100 planned participants after an unplanned interim analysis confirmed the primary PFS endpoint had been reached.
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The randomized, controlled design evaluated the clinical benefit of palifosfamide tris administered with doxorubicin in combination, compared with single-agent doxorubicin, in subjects diagnosed with unresectable or metastatic soft-tissue sarcoma.
copied source wording
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