A Study of Fluzoparib（SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer

June 30, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

An Open-Label Study to Assess the Efficacy And Safety of Poly(ADP-ribose) Polymerase Inhibitor Fluzoparib（SHR3162）in Patients With Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer and BRCA1/2 Mutation

This is a multicenter， open-label study to evluate the efficacy and safety of a novel PARP 1/2 inhibitor fluzoparib （SHR-3162）in BRCA1/2-mutant Relapsed Ovarian Cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Fluzoparib (SHR-3162) is an orally available, small molecule inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) 1/2 being developed for treatment of BRCA1/2-mutant solid tumor. The tolerability, safety and PK of fluzoparib has been evaluated in Phase 1 study. An oral formulation is the focus of current development efforts.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 1

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

  • China
    • Beijing
      • Beijing, Beijing, China
        • Cancer Hospital Chinese Academy of Medical Sciences

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 confirmed diagnosis of high grade serous or Grade 2/3 endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer；
  • Confirmed documented BRCA1/2 mutation;
  • Received 2~4 prior chemotherapy regimens. Non-chemotherapy regimens and maintenance therapies administered as single agent treatment will not count as a chemotherapy regimen；
  • Relapsed/progressive disease as confirmed by radiologic assessment；
  • Have measurable disease as defined by RECIST v1.1.

Exclusion Criteria:

  • Any previous treatment with a PARP inhibitor;
  • Patient with any other malignancy which has been active or treated within the previous 5 years;
  • Patients with symptomatic uncontrolled brain metastases;
  • Patients unable to swallow orally administered medication.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Fluzoparib capsule
Drug: Fluzoparib
Fluzoparib capsule will be given twice daily orally
Other Names:
  • SHR-3162

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR by RECIST v1.1
Time Frame: every 8 weeks (±7 days) of treatment
Objective response rate
every 8 weeks (±7 days) of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DoR
Time Frame: study data collection expected to last for ~2 years
Duration of response
study data collection expected to last for ~2 years
PFS
Time Frame: expected to last for ~2 years
Progression free survival
expected to last for ~2 years
Response rate by GCIG CA-125
Time Frame: every 8 weeks (±7 days) of treatment expected to last for ~2 years
Response rate per GCIG CA-125
every 8 weeks (±7 days) of treatment expected to last for ~2 years
OS
Time Frame: study data collection expected to last for ~2 years
Overall suvival
study data collection expected to last for ~2 years
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications
Time Frame: Every day starting with signing of consent until 30 days after discontinuation of treatment
per CTC AE 4.03
Every day starting with signing of consent until 30 days after discontinuation of treatment
Trough (Cmin) level of fluzoparib concentrations
Time Frame: Cycle 1 to cycle 4(each cycle is 28 days)
Cssmin of fluzoparib concentrations
Cycle 1 to cycle 4(each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

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 4, 2018

Primary Completion (Actual)

August 26, 2019

Study Completion (Actual)

July 23, 2020

Study Registration Dates

First Submitted

February 25, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (Actual)

April 26, 2018

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR-FZPL-Ⅰb-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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