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

Phase 3

• Conditions: Ovarian Cancer
• Interventions: Drug: Placebo capsules; Drug: Fluzoparib capsules

• Registration Number: NCT03863860
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-25
• Study First Submitted QC: 2019-03-03
• Study First Posted: 2019-03-05
• Study Start: 2019-04-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-10
• Last Update Posted: 2022-06-13
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 252

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo capsules, 50mg per capsule	Placebo capsules	Placebo capsules, PO
Fluzoparib capsules, 50mg per capsule	Fluzoparib capsules	Fluzoparib capsules, PO

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Progression free survival(PFS) in relapsed ovarian cancer patients	up to 2 years	PFS is Progression-Free-Survival 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
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)
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.
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
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

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China