Clinical trial · Interventional
A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer
NCT03863860CI-TRIAL-00091700completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluzoparib capsules | Drug | — | UNRESOLVED |
| Placebo capsules | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fluzoparib capsules, 50mg per capsule
- description
- Fluzoparib capsules, PO
- interventionNames
- Drug: Fluzoparib capsules
- type
- PLACEBO_COMPARATOR
- label
- Placebo capsules, 50mg per capsule
- description
- Placebo capsules, PO
- interventionNames
- Drug: Placebo capsules
Primary outcomes (2)
- measure
- Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) 2. Completion of ≥2 previous platinum-containing regimens 3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator 4. Ability to be randomized ≤8 weeks after last dose of platinum Exclusion Criteria: 1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor 2. Patients who have received other study drug treatment within 4 weeks prior to the first administration(\< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs). 3. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.
References
Publications (1)
- DERIVEDLi N, Zhang Y, Wang J, Zhu J, Wang L, Wu X, Yao D, Wu Q, Liu J, Tang J, Yin R, Lou G, An R, Zhang G, Xia X, Li Q, Zhu Y, Zheng H, Yang X, Hu Y, Zhang X, Hao M, Huang Y, Lin Z, Wang D, Guo X, Yao S, Wan X, Zhou H, Yao L, Yang X, Cui H, Meng Y, Zhang S, Qu J, Zhang B, Zou J, Wu L. Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial. J Clin Oncol. 2022 Aug 1;40(22):2436-2446. doi: 10.1200/JCO.21.01511. Epub 2022 Apr 11. PMID 35404684