NCT03863860

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P25-P50 for phase_3 ovarian-cancer

Timeline
Completed

Started Apr 2019

Typical duration for phase_3 ovarian-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2022

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2025

Completed
Last Updated

July 3, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

February 25, 2019

Last Update Submit

July 2, 2025

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • Progression free survival(PFS) in relapsed ovarian cancer patients

    up to 2 years

  • Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria

    up to 2 years

  • Chemotherapy free interval (CFI) CFI

    up to 2 years

  • overall survival(OS)

    up to 3 years

  • Objective Response Rate

    At baseline,at the time point of every 12 weeks, up to 2 years

  • +1 more secondary outcomes

Study Arms (2)

Fluzoparib capsules, 50mg per capsule

EXPERIMENTAL

Fluzoparib capsules, PO

Drug: Fluzoparib capsules

Placebo capsules, 50mg per capsule

PLACEBO COMPARATOR

Placebo capsules, PO

Drug: Placebo capsules

Interventions

Fluzoparib capsulesDRUG

Fluzoparib capsules

Also known as: SHR-3162
Fluzoparib capsules, 50mg per capsule
Placebo capsulesDRUG

Placebo capsule

Also known as: Placebo
Placebo capsules, 50mg per capsule

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

Related Publications (1)

  • 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.

    PMID: 35404684DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Lingying Wu

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 5, 2019

Study Start

April 30, 2019

Primary Completion

January 10, 2022

Study Completion

June 19, 2025

Last Updated

July 3, 2025

Record last verified: 2025-07

Locations

CN(1)