drugset / Trial / NCT05460000
A Phase II Randomized, Open Label Non-inferiority Study of NiraParib Maintenance After 3 vs. 6 Cycles of Platinum-based Chemotherapy in completeLy debUlked Advanced HRDpositive High-grade Ovarian Cancer patientS in First Line Therapy
Phase 2
Recruiting
640 enrolled
North Eastern German Society of Gynaecological Oncology
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Multicenter, randomized, open label study including patients with advanced HRDpositive high-grade ovarian cancer, fallopian tube cancer, primary peritoneal cancer and clear cell carcinoma of the ovary with no residual tumor mass following primary tumor debulking to determine recurrence free survival in patients treated with 3 cycles carboplatin + paclitaxel and maintenance therapy with niraparib vs. 6 cycles carboplatin + paclitaxel and maintenance therapy with niraparib.
Timeline
- Start
- 2024-10-11
- Primary completion
- 2032-10-01
- Completion
- 2032-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Carboplatin | Small molecule | — | — |
| Subject | Paclitaxel | Small molecule | — | — |
| Background | 3 cycles chemotherapy instead of 6 cycles chemotherapy | Unknown | 200 mg | — |
| Background | 3 cycles chemotherapy instead of 6 cycles chemotherapy | Unknown | 300 mg | — |