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This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety Lead-in, Doublet Arm | Experimental | Fluzoparib+Apatinib |
|
| Single Arm | Experimental | Fluzoparib |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib; Apatinib | Drug | Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| (Safety Lead-in) Incidence of ≥3 grade TRAEs | Incidence of ≥3 grade treatment related adverse events | up to 28 days after the last patient of the lead-in phase |
| (Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients | Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria | up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| AEs+SAEs | Adverse Events and Serious Adverse Events | from the first drug administration to within 30 days for the last treatment dose |
| PFS by investigator's assessment | Progression-Free-Survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
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| Fluzoparib | Drug | Fluzoparib Orally twice daily |
|
| Placebo | Drug | Placebo |
|
| up to 4 years |
| OS | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up | up to 6 years |
| Patients reported outcome(PROs)assessed by EQ-5D-5L questionnaire | Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire | 48 months |
| Patients reported outcome(PROs)assessed by FOSI questionnaire | Comparison of the Quality of Life in study arms assessed by FOSI questionnaire | 48 months |
| Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first. | From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first. | 4 years |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| 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 |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
| C553458 | apatinib |
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