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Clinical trial of niraparib and platinum-taxane dual chemotherapy in participants with stage III/IV ovarian cancer with homologous recombination deficiency.
THE OBJECTIVE OF THIS STUDY IS TO INVESTIGATE HOW NIRAPARIB WORKS IN THE TREATMENT OF WOMEN WITH NEWLY DIAGNOSED OVARIAN CANCER BEFORE THE FIRST MAJOR SURGERY. INFORMATION WILL BE OBTAINED ON WHETHER NIRAPARIB WORKS IN THE TREATMENT OF THEIR DISEASE BY EITHER DELAYING OR PREVENTING RECURRENCE WHEN COMPARED TO THE CURRENT REFERENCE TREATMENT. IT WILL ALSO BE INVESTIGATED WHETHER IT IS SAFE, AND WHAT IS THE MOST APPROPRIATE DOSE.
Technical Summary
- PHASE II, OPEN-LABEL, RANDOMIZED, CONTROLLED, MULTICENTER STUDY TO COMPARE NIRAPARIB VERSUS PLATINUM-TAXANE DOUBLET CHEMOTHERAPY AS NEOADJUVANT TREATMENT IN PARTICIPANTS WITH STAGE III/IV OVARIAN CANCER WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (OPAL-COHORTE C).
- Code EudraCT: 2021-005392-39
- Protocol number: 213357
- Promoter: GlaxoSmithKline
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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