drugset / Trial / NCT03983226
Surgery and Niraparib in Secondary Recurrent Ovarian Cancer (SOC-3 Trial)
Phase 2
Recruiting
167 enrolled
Shanghai Gynecologic Oncology Group
Fudan University · collabShanghai Jiao Tong University School of Medicine · collabSun Yat-sen University · collabZhejiang Cancer Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.
Timeline
- Start
- 2019-10-18
- Primary completion
- 2025-06
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | — | — |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Gemcitabine | Small molecule | — | — |