At a glance
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PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin Combination Chemotherapy With or Without APR-246
In Brief
A Phase 2 clinical trial evaluating APR-246 and Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD) for Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53. Completed, enrolled 247 participants across 55 sites in 8 countries.
Detailed Summary
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen, compared with carboplatin/PLD chemotherapy regimen alone, in patients with platinum sensitive recurrent high grade serous ovarian cancer (HGSOC) with mutated p53. In addition, the study aims to assess the safety profile of the combined APR-246 and carboplatin/PLD chemotherapy regimen compared with carboplatin/PLD chemotherapy regimen alone, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll up to a maximum of 400 patients.
Study Details
Timeline
Interventions
Intravenous infusion.
Intravenous infusion.