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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib capsules, 50mg per capsule | Experimental | Fluzoparib capsules, PO |
|
| Placebo capsules, 50mg per capsule | Placebo Comparator | Placebo capsules, PO |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib capsules | Drug | Fluzoparib capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients | Defined as progression free survival per RECIST 1.1 criteria | up to 2 years |
| Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant | Defined as progression free survival per RECIST 1.1 criteria | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) in relapsed ovarian cancer patients | PFS is Progression-Free-Survival per RECIST 1.1 criteria | up to 2 years |
| Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lingying Wu | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35404684 | Derived | Li 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. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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| Placebo capsules | Drug | Placebo capsule |
|
|
TTP is Time to Progression
| up to 2 years |
| Chemotherapy free interval (CFI) CFI | CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen) | up to 2 years |
| overall survival(OS) | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to 3 years |
| Objective Response Rate | Objective Response Rate complete or partial response per RECIST 1.1 criteria | At baseline,at the time point of every 12 weeks, up to 2 years |
| Adverse Events(AEs) and Serious Adverse Events (SAEs) | assess the safety and tolerability of Fluzoparib maintenance monotherapy in platinum sensitive relapsed ovarian cancer patients by record the number of Participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc. | from the first drug administration to within 30 days for the last treatment dose |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |