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

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

Trial Details

NCT ID

NCT07460180

Phase

PHASE1 / PHASE2

Sponsor

The Netherlands Cancer Institute

Status

RECRUITING

Cancer Type

Ovarian Cancer

Interventions

• Olaparib

Locations (sample)

• Amsterdam, Netherlands|52.37403,4.88969

Key Eligibility Criteria

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Signed and written informed consent
• At least 18 years of age and able to understand patients' information
• FIGO stage III primary high-grade serous ovarian, fallopian tube, or extra-ovarian cancer.

For full eligibility, visit ClinicalTrials.gov.

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