Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Carcinoma
Conditions
Brief summary
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.
Interventions
Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily
DRUGFluzoparib
Fluzoparib Orally twice daily
DRUGPlacebo
Placebo
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* （phase 3）Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) * （phase 3）Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator * （phase 3）Ability to be randomized ≤8 weeks after last dose of platinum * （Saftey Lead-in）Received 2\ 4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1.
Exclusion criteria
* Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib * 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Safety Lead-in) Incidence of ≥3 grade TRAEs | up to 28 days after the last patient of the lead-in phase | Incidence of ≥3 grade treatment related adverse events |
| (Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients | up to 4 years | Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | up to 6 years | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up |
| Patients reported outcome（PROs）assessed by EQ-5D-5L questionnaire | 48 months | Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire |
| AEs+SAEs | from the first drug administration to within 30 days for the last treatment dose | Adverse Events and Serious Adverse Events |
| 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. | 4 years | From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first. |
| Patients reported outcome（PROs）assessed by FOSI questionnaire | 48 months | Comparison of the Quality of Life in study arms assessed by FOSI questionnaire |
| PFS by investigator's assessment | up to 4 years | Progression-Free-Survival |
Countries
China
Outcome results
None listed