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PiSARRO: APR-246 + Carboplatin/PLD in Ovarian Cancer
NCT02098343Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2014
- Primary completion
- Apr 2019
- Countries
- 8
- Sponsor
- Aprea Therapeutics
- Modality
- Small Molecules
- Drugs
- eprenetapopt
- Conditions
- High-Grade Serous Ovarian Carcinoma (HGSOC)
01
Overview
Phase 2, randomised, open-label trial of eprenetapopt in High-Grade Serous Ovarian Carcinoma (HGSOC) (5 arms), sponsored by Aprea Therapeutics. Primary endpoints: Dose-limiting Toxicities at Day 28 and Progression Free Survival at 24 months. Started Mar 2014; status: completed.
02
Design
5 arms- Study design
- RandomizedOpen-label
Phase Ib: APR-246 35mg/kg + Chemo
APR-246 (35mg/kg) + Carboplatin/PLD
Phase Ib: APR-246 50mg/kg + Chemo
APR-246 (50mg/kg) + Carboplatin/PLD
Phase Ib: APR-246 67.5mg/kg + Chemo
APR-246 (67.5mg/kg) + Carboplatin/PLD
Phase II Arm A: APR-246 + Chemo
APR-246 (RP2D) + Carboplatin/PLD
Phase II Arm B: Chemo Alone
Carboplatin/PLD
03
Who it enrols
Patients with platinum-sensitive recurrent high-grade serous ovarian cancer with confirmed p53 mutation, ECOG 0-1, and adequate organ function.
04
Endpoints
Primary
Dose-limiting Toxicities
Progression Free Survival
Secondary
Overall Response Rate
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