Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherap
This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer.
| Condition(s) | Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This is an international, multicenter, randomized, open, Phase III trial to evaluate the efficacy and safety of carboplatin/paclitaxel/bevacizumab followed by bevacizumab and niraparib compared to carboplatin/paclitaxel followed by niraparib in patients with newly diagnosed advanced ovarian cancer. |
| Who can participate | Inclusion Criteria: 1. Signed written informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the clinical trial requirements. 2. Female patients ≥ 18 years with histologically confirmed primary advanced invasive high grade non-mucinous, non-clear cell epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO stage IIIA2 without nodal involvement) according to recent FIGO classification (= FIGO stage IIIB - IV according to FIGO 2009 classification). 3. All patients must have had either upfront primary debulking surgery OR plan to undergo chemotherapy with interval debulking surgery. 4. Patients must have available tumor samples to be sent to c |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | AGO Study Group |
| Locations | Amberg, Germany; Augsburg, Germany; Bad Homburg, Germany; Berlin, Germany; Bielefeld, Germany; Brandenburg an der Havel, Germany (+59 more sites) |
| Start date | 2022-09-13 |
| NCT ID | NCT05009082 |
| Official listing | https://clinicaltrials.gov/study/NCT05009082 |