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This study is a Phase II randomized, open label, controlled, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib versus fluzoparib monotherapy for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma (including patients previous treated with a PARP inhibitor).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluzoparib+Apatinib combination | Experimental |
| |
| Fluzoparib Monotherapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib+Apatinib | Drug | Fluzoparib 100mg bid+ Apatinib 375mg qd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) in previous PARP inhibitor treated relapsed ovarian cancer patients. | To determine the efficacy by progression free survival (PFS) of the maintenance treatment in previous PARP inhibitor treated platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined). | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) in relapsed ovarian patients | To determine the efficacy by progression free survival (PFS) of the maintenance treatment in platinum-sensitive relapsed ovarian cancer patients according to RECIST v1.1 criteria (Investigator determined). | Up to 2 years |
| Progression Free Survival (PFS) in BRCA1/2 mutated relapsed ovarian cancer patients. |
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Inclusion Criteria:
The patient voluntarily joined the study and signed the informed consent
Patients ≥18 years of age.
Participant has histologically confirmed diagnosis of high-grade predominantly serous ovarian cancer, fallopian tube cancer, primary peritoneal cancer; ≥grade II ovarian endometrioid adenocarcinoma.
Participant has received 2 or 3 previous lines of platinum-containing therapy and the last chemotherapy course contains platinum regimen.
Patient defined as platinum sensitive after this treatment; defined as disease progression greater than 6 months (184 days) after completion of their last dose of platinum chemotherapy
Participant has responded to last the platinum regimen (complete or partial response), remains in response and is enrolled on study within 8 weeks of completion of the last platinum regimen.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to enrollment.
Participant had prior treatment with PARP inhibitor in a maintenance setting:
Participant has adequate organ function as defined in the following contents (Any blood component or cell growth factor within 14 days prior to randomization is not permitted) Absolute neutrophil count (ANC) ≥1.5×109/L Platelets ≥100×109/L Hemoglobin ≥10g/dL Serum albumin ≥3g/dL Total bilirubin ≤1.5 ×ULN AST (SGOT) and ALT (SGPT) ≤3 × ULN Serum creatinine ≤1.5 × ULN
Patients with potential fertility need to use a medically approved contraceptive (such as an intrauterine device, birth control pill or condom) during and for 3 months after the study period; Serum HCG or urine HCG must be negative within 72 hours prior to study enrollment; must be a non-lactation period.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Wu, Ph.D., MD | Contact | +86 021-64175590 | wu.xh@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohua Wu, Ph.D., MD | Department of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 270 Dong-An Road, Shanghai 200032, China. | Principal Investigator |
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Data is available per require after approved by ethics broad
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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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| Fluzoparib Monotherapy |
| Drug |
Fluzoparib 150mg bid |
|
| Up to 2 years |
| Objective Response Rate (ORR) | Up to 2 years |
| Disease Control Rate (DCR) | Up to 2 years |
| Duration of Response (DoR) | Up to 2 years |
| Overall survival (OS) | Up to 2 years |
| Adverse Events (AEs) | Assese the safety and tolerability of Fluzoparib combined with apatinib maintenance 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 |