RecruitingPhase 1Phase 2NCT07460180

The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer

Sponsor

The Netherlands Cancer Institute

Enrollment

55 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Cancer Fallopian Tube Cancer Epithelial Cancer

Summary

The PROOV study is an open-label, monocenter, single-arm, prospective phase I/II trial with a safety lead-in, evaluating the feasibility of combining PARPi with HIPEC in stage III EOC patients. Phase I is a dose-finding phase with a time-to-event Bayesian Optimal Interval (TITE-BOIN) design, in which three doses of olaparib are evaluated to identify the optimal dose for the phase II part and future trials. The recommended phase II dose (RP2D) will be determined based on the experienced DLTs per dose level and the level of intra-tumor and systemic enzymatic PARP inhibition. During Phase II, the safety profile of the RP2D will be assessed in a total cohort of 40 patients. To provide a proof-of-concept, efficacy will be explored in both translational analyses and survival data.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new treatment combination for ovarian cancer during surgery. It combines a type of targeted cancer drug (called a PARP inhibitor), a chemotherapy drug (cisplatin), and a heated chemotherapy wash inside the belly (called HIPEC) during tumor removal surgery. The goal is to see if combining these treatments works better together than any single approach. **You may be eligible if...** - You are at least 18 years old - You have been diagnosed with advanced (stage III or certain stage IV) high-grade serous ovarian, fallopian tube, or related cancer - Your diagnosis has been confirmed by tissue or fluid testing - You are able to understand study information and sign consent **You may NOT be eligible if...** - Your cancer is at a very advanced stage with extensive spread - You have certain health conditions that make surgery unsafe - You cannot tolerate the combination of treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlaparib

seven days of PARPi (olaparib, Lynparza®) twice a day. The dosage will be either 100mg, 150mg or 300mg, depending on the phase of the trial.

Locations(1)

NKI-AvL

Amsterdam, Netherlands

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NCT07460180

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