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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03863860
• Other study ID #: FZPL-?-301-OC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 30, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 252
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Fluzoparib capsules
Fluzoparib capsules
• Placebo capsules
Placebo capsule

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Progression free survival(PFS) in relapsed ovarian cancer patients	PFS is Progression-Free-Survival per RECIST 1.1 criteria	up to 2 years
Secondary	Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria	TTP is Time to Progression	up to 2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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