Ovarian Cancer
Conditions
Brief summary
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
Interventions
Fluzoparib capsules
DRUGPlacebo capsules
Placebo capsule
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients | up to 2 years | Defined as progression free survival per RECIST 1.1 criteria |
| Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant | up to 2 years | Defined as progression free survival per RECIST 1.1 criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chemotherapy free interval (CFI) CFI | up to 2 years | CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen) |
| overall survival(OS) | up to 3 years | OS is the time interval from the start of treatment to death due to any reason or lost of follow-up |
| Progression free survival(PFS) in relapsed ovarian cancer patients | up to 2 years | PFS is Progression-Free-Survival per RECIST 1.1 criteria |
| Adverse Events(AEs) and Serious Adverse Events (SAEs) | from the first drug administration to within 30 days for the last treatment dose | 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. |
| Objective Response Rate | At baseline,at the time point of every 12 weeks, up to 2 years | Objective Response Rate complete or partial response per RECIST 1.1 criteria |
| Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria | up to 2 years | TTP is Time to Progression |
Countries
China
Outcome results
None listed