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p53 Activation in Platinum-Resistant High Grade Serous Ovarian Cancer, a Study of PLD With APR-246

NCT03268382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-03-17

Study results available
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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.

Conditions

  • High-grade Serous Ovarian Cancer

Interventions

DRUG

APR-246

Intravenous infusion

DRUG

Pegylated Liposomal Doxorubicin Hydrochloride (PLD)

Intravenous infusion

Sponsors & Collaborators

  • Aprea Therapeutics

    lead INDUSTRY

Principal Investigators

  • Charlie Gourley, BSc, MB ChB, PhD, FRCP · Edinburgh Cancer Research Centre, The University of Edinburgh

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2019-07-10
Completion
2019-07-10
FDA Drug
Yes

Countries

  • Belgium
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03268382 on ClinicalTrials.gov