drugset / Trial / NCT05009082
Niraparib vs Niraparib Plus Bevacizumab in Patients With Platinum/Taxane-based Chemotherapy in Advanced Ovarian Cancer
Phase 3
Recruiting
970 enrolled
AGO Study Group
European Network of Gynaecological Oncological Trial Groups (ENGOT) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2022-09-13
- Primary completion
- 2028-12
- Completion
- 2031-12
Publications
- Heitz F, Marth C, Henry S, Reuss A, Cibula D, Gaba Garcia L, Colombo N, Schmalfeld B, de Gregorio N, Wimberger P, Hasenburg A, Sehouli J, Gropp-Meier M, Schouten PC, Hahnen E, Hauke J, Polleis S, Harter P. AGO-OVAR 28/ENGOT-ov57. Niraparib alone versus niraparib in combination with bevacizumab in patients with carboplatin-taxane-based chemotherapy in advanced ovarian cancer: a multicenter randomized phase III trial. Int J Gynecol Cancer. 2023 Dec 4;33(12):1966-1969. doi: 10.1136/ijgc-2023-004944.
- Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bevacizumab | Monoclonal antibody | 7.5 mg/kg | Intravenous |
| Comparator | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Niraparib | Small molecule | 200 mg | Oral |
| Comparator | Niraparib | Small molecule | 300 mg | Oral |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |