Clinical Trial

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

Study acronym: PROOV
Recruiting Phase 1/2
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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.
Trial Details
NCT Number NCT07460180
Lead Sponsor The Netherlands Cancer Institute
Conditions Ovarian Cancer, Epithelial Cancer, Fallopian Tube Cancer
Enrollment 55 participants
Start Date 2025-05-01
Primary Completion 2027-05-01 (estimated)
Study Completion 2032-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-03-10