A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients

Study Overview
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Brief Summary
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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

Official Title
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A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: Fluzoparib capsules
* Drug: Placebo capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer) Completion of ≥2 previous platinum-containing regimens Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator Ability to be randomized ≤8 weeks after last dose of platinum Exclusion Criteria: Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluzoparib capsules, 50mg per capsule<br>Fluzoparib capsules, PO | Drug: Fluzoparib capsules<br>* Fluzoparib capsules<br>* Other names: SHR-3162;|
| Placebo Comparator: Placebo capsules, 50mg per capsule<br>Placebo capsules, PO | Drug: Placebo capsules<br>* Placebo capsule<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |