Back to resultsA Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
Primary Purpose
Ovarian Cancer
Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fluzoparib capsules
Placebo capsules
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer
Eligibility Criteria
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.
Sites / Locations
- Cancer Hospital Chinese Academy of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Fluzoparib capsules, 50mg per capsule
Placebo capsules, 50mg per capsule
Arm Description
Fluzoparib capsules, PO
Placebo capsules, PO
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Progression free survival(PFS) in relapsed ovarian cancer patients
PFS is Progression-Free-Survival per RECIST 1.1 criteria
Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria
TTP is Time to Progression
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)
overall survival(OS)
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Objective Response Rate
Objective Response Rate complete or partial response per RECIST 1.1 criteria
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.
Full Information
NCT ID
NCT03863860
First Posted
February 25, 2019
Last Updated
June 10, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03863860
Brief Title
A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluzoparib capsules, 50mg per capsule
Arm Type
Experimental
Arm Description
Fluzoparib capsules, PO
Arm Title
Placebo capsules, 50mg per capsule
Arm Type
Placebo Comparator
Arm Description
Placebo capsules, PO
Intervention Type
Drug
Intervention Name(s)
Fluzoparib capsules
Other Intervention Name(s)
SHR-3162
Intervention Description
Fluzoparib capsules
Intervention Type
Drug
Intervention Name(s)
Placebo capsules
Other Intervention Name(s)
Placebo
Intervention Description
Placebo capsule
Primary Outcome Measure Information:
Title
Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients
Description
Defined as progression free survival per RECIST 1.1 criteria
Time Frame
up to 2 years
Title
Progression free survival(PFS) by BIRC in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant
Description
Defined as progression free survival per RECIST 1.1 criteria
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Progression free survival(PFS) in relapsed ovarian cancer patients
Description
PFS is Progression-Free-Survival per RECIST 1.1 criteria
Time Frame
up to 2 years
Title
Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria
Description
TTP is Time to Progression
Time Frame
up to 2 years
Title
Chemotherapy free interval (CFI) CFI
Description
CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)
Time Frame
up to 2 years
Title
overall survival(OS)
Description
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Time Frame
up to 3 years
Title
Objective Response Rate
Description
Objective Response Rate complete or partial response per RECIST 1.1 criteria
Time Frame
At baseline,at the time point of every 12 weeks, up to 2 years
Title
Adverse Events(AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
from the first drug administration to within 30 days for the last treatment dose
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lingying Wu
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35404684
Citation
Li N, Zhang Y, Wang J, Zhu J, Wang L, Wu X, Yao D, Wu Q, Liu J, Tang J, Yin R, Lou G, An R, Zhang G, Xia X, Li Q, Zhu Y, Zheng H, Yang X, Hu Y, Zhang X, Hao M, Huang Y, Lin Z, Wang D, Guo X, Yao S, Wan X, Zhou H, Yao L, Yang X, Cui H, Meng Y, Zhang S, Qu J, Zhang B, Zou J, Wu L. Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive, Recurrent Ovarian Carcinoma (FZOCUS-2): A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Trial. J Clin Oncol. 2022 Aug 1;40(22):2436-2446. doi: 10.1200/JCO.21.01511. Epub 2022 Apr 11.
Results Reference
derived
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A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
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