The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer
Recruiting
Phase 1
Phase 2
Interventional Study
Ovarian Cancer
Epithelial Cancer
Fallopian Tube Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 100
- Sex
- Female
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 55 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Other
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About This Trial
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 futur…
Trial Locations
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Eligibility Criteria
Inclusion 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, fal…
Contacts