NCT02098343

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 247 (actual)
• Sponsor: Aprea Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Platinum Sensitive Recurrent High-grade Serous Ovarian Cancer With Mutated p53

Interventions

Type	Name	Description
DRUG	APR-246	Intravenous infusion.
DRUG	Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)	Intravenous infusion.

Timeline

• Start date: 2014-03-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2014-03-28
• Last updated: 2025-03-17
• Results posted: 2022-09-21

Locations

55 sites across 8 countries: United States, Belgium, France, Germany, Netherlands, Spain, Sweden, United Kingdom