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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509636
• Other study ID #: HR-FZPL-?b-OC
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2018
• Est. completion date: July 23, 2020

Study information

• Verified date: June 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: July 23, 2020
• Est. primary completion date: August 26, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Fluzoparib
Fluzoparib capsule will be given twice daily orally

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR by RECIST v1.1	Objective response rate	every 8 weeks (±7 days) of treatment
Secondary	DoR	Duration of response	study data collection expected to last for ~2 years
Secondary	PFS	Progression free survival	expected to last for ~2 years
Secondary	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
Secondary	OS	Overall suvival	study data collection expected to last for ~2 years
Secondary	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
Secondary	Trough (Cmin) level of fluzoparib concentrations	Cssmin of fluzoparib concentrations	Cycle 1 to cycle 4(each cycle is 28 days)