At a glance
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Phase I/II Study of PCI-24781 in Combination With Doxorubicin for Treatment of Advanced Sarcomas Following Failure or Prior Anthracycline Therapy
In Brief
A Phase 2 clinical trial evaluating PCI-24781, Doxorubicin, and 1 other intervention for Sarcoma. Completed, enrolled 20 participants across 2 sites.
Detailed Summary
The purpose of this research study is to determine the safety and maximum tolerated dose of PCI-24781 that can be given safely with doxorubicin (phase I) and the safety and efficacy of PCI-24781 when used in combination with doxorubicin (phase II) in patients with advanced sarcomas. The study drug, PCI-24781, is believed to regulate genes involved in tumor cell growth. The other study drug, doxorubicin, is considered a standard chemotherapeutic treatment for advanced sarcoma patients. We hypothesize that combining PCI-24781 with doxorubicin can overcome chemoresistance to doxorubicin.
Study Details
Timeline
Interventions
Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle
Administered intravenously on Day 4 of each 3 week cycle
Administered on Day 5 of each 3 weeks cycle in Arm 1 if determined to be clinically indicated, and in all patients enrolled into Arm 2