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

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: Ovarian Cancer
• Intervention / Treatment: Drug: Fluzoparib

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	Objective response rate	every 8 weeks (±7 days) of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DoR	Duration of response	study data collection expected to last for ~2 years
PFS	Progression free survival	expected to last for ~2 years
Response rate by GCIG CA-125	Response rate per GCIG CA-125	every 8 weeks (±7 days) of treatment expected to last for ~2 years
OS	Overall suvival	study data collection expected to last for ~2 years
Incidence of adverse events, clinical laboratory abnormalities, and dose modifications	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	Cssmin of fluzoparib concentrations	Cycle 1 to cycle 4(each cycle is 28 days)

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

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: 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: 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