CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
APR-246 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03268382
NCT03268382Phase 2Completed
CompareCT.gov

PiSARRO-R: p53 Suppressor Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Phase II Study of Systemic Pegylated Liposomal Doxorubicin Chemotherapy With APR-246

Aprea Therapeutics·interventional·Posted Aug 31, 2017·Updated Mar 17, 2025

In Brief

A Phase 2 clinical trial evaluating APR-246 and Pegylated Liposomal Doxorubicin Hydrochloride (PLD) for High-grade Serous Ovarian Cancer. Completed, enrolled 36 participants across 12 sites in 3 countries.

Detailed Summary

The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHigh-grade Serous Ovarian Cancer
CountriesBelgium, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 31, 2017
Enrollment StartJul 31, 2017
Primary CompletionJul 10, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 8.8 years ago

Interventions

APR-246drug

Intravenous infusion

Pegylated Liposomal Doxorubicin Hydrochloride (PLD)drug

Intravenous infusion