- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03863860
A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients
June 10, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
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
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
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
252
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China
- Cancer Hospital Chinese Academy of Medical Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fluzoparib capsules, 50mg per capsule
Fluzoparib capsules, PO
|
Fluzoparib capsules
Other Names:
|
Placebo Comparator: Placebo capsules, 50mg per capsule
Placebo capsules, PO
|
Placebo capsule
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival(PFS) by Blinded Independent Review Committee (BIRC) in relapsed ovarian cancer patients
Time Frame: up to 2 years
|
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
Time Frame: up to 2 years
|
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
Time Frame: up to 2 years
|
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
Time Frame: up to 2 years
|
TTP is Time to Progression
|
up to 2 years
|
Chemotherapy free interval (CFI) CFI
Time Frame: 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)
|
up to 2 years
|
overall survival(OS)
Time Frame: 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
|
up to 3 years
|
Objective Response Rate
Time Frame: 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
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At baseline,at the time point of every 12 weeks, up to 2 years
|
Adverse Events(AEs) and Serious Adverse Events (SAEs)
Time Frame: 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.
|
from the first drug administration to within 30 days for the last treatment dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2019
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
December 31, 2022
Study Registration Dates
First Submitted
February 25, 2019
First Submitted That Met QC Criteria
March 3, 2019
First Posted (Actual)
March 5, 2019
Study Record Updates
Last Update Posted (Actual)
June 13, 2022
Last Update Submitted That Met QC Criteria
June 10, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- FZPL-Ⅲ-301-OC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Roswell Park Cancer InstituteCompletedFallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IIA Ovarian Cancer | Stage IIB Ovarian Cancer | Stage IIC Ovarian Cancer | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer | Stage IA Ovarian Cancer | Stage IB Ovarian Cancer | Stage IC... and other conditionsUnited States
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Eve RodlerNot yet recruitingBreast Cancer | Ovarian Cancer | Breast Neoplasm | Breast Carcinoma | Breast Cancer Stage IV | Breast Cancer Stage I | Breast Cancer Stage II | Invasive Breast Cancer | Cancer, Breast | Breast Cancer Stage III | Ovary Cancer | Malignant Tumor of Breast | Ovarian Cancer Stage IIIC | Ovarian Cancer Stage IV | Ovarian Cancer... and other conditionsUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
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