OncoMatch/Clinical Trials/NCT07460180
The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer
Is NCT07460180 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Olaparib for ovarian cancer.
Treatment: Olaparib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Ovarian Cancer
Disease stage
Required: Stage III, IV
Performance status
WHO 0–2
Prior therapy
Must have received: platinum-based chemotherapy (carboplatin, paclitaxel) — neoadjuvant
Neo-adjuvant chemotherapy consists of at least 3 courses of carboplatin/paclitaxel; Patients should have response or stable disease after NACT; no progression should occur
Cannot have received: chemotherapy for previous malignancy
History of previous malignancy treated with chemotherapy
Lab requirements
Blood counts
hemoglobin level >5.5 mmol/l, leukocytes >3 x10^9/l, platelets > 100 x10^9/l
Kidney function
creatinine clearance ≥ 60 ml/min using cockcroft-gault formula or 24-hour measurement or ml/min/1,73 m2 using mdrd or ckd-epi
Liver function
alt, ast, and bilirubin < 2.5 times the upper limit of normal
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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