Trials / Recruiting
RecruitingNCT05183984
Niraparib With beVAcizumab After Complete cytoreductioN in Patients With ovArian Cancer
Randomized Study of Paclitaxel-carboplatin Followed by Niraparib Compared to Paclitaxel-carboplatin-bevacizumab Followed by Niraparib+Bevacizumab in Patients With Advanced Ovarian Cancer, Following a Front-line Complete Surgery
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- Sponsor
- ARCAGY/ GINECO GROUP · Academic / Other
- Sex
- Female
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
Randomized, open label, phase II multicenter study to assess the efficacy niraparib versus niraparib +bevacizumab maintenance in patients with newly diagnosed stage IIIA/B/C high-grade epithelial ovarian cancer with no residual disease after frontline surgery and treatment by adjuvant platinum-basedchemotherapy +/-bevacizumab.
Detailed description
Phase II, randomized, open label, multicenterstudy. Randomization on a 1:1 ratio, stratification performed according to: BRCA status (local assessment) FIGO stage at diagnosis (IIIA versus IIIB/IIIC) Previous hyperthermic intraperitoneal chemotherapy (yes/no).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Chemotherapy | Chemotherapy (carboplatin + paclitaxel) will be administred by intravenous infusion, AUC 5-6 q3w - 5 cycles during the treatment period |
| DRUG | Bevacizumab-Awwb | MVASI (bevacizumab biosimilar) will be administrated by intravenous infusion at the second chemotherapy cycle for 5 cycles. the administration will continue during maintenance phase. Total bevacizumab duration therapy is 15 months. |
| DRUG | Niraparib | niraparib will be administered orally once daily continuously after chemotherapy (+/- bevacizumab) cycles (maintenance treatment period). Total niraparib duration mainance treatment period is 2 years. |
Timeline
- Start date
- 2022-02-01
- Primary completion
- 2027-02-01
- Completion
- 2032-02-01
- First posted
- 2022-01-11
- Last updated
- 2026-04-13
Locations
88 sites across 6 countries: France, Italy, Japan, Singapore, South Korea, Spain
Source: ClinicalTrials.gov record NCT05183984. Inclusion in this directory is not an endorsement.