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NCT Number: NCT03509636

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluzoparib

Drug

Fluzoparib capsule will be given twice daily orally

Other names: SHR-3162

Primary outcomes

  1. ORR by RECIST v1.1

    Time frame: every 8 weeks (±7 days) of treatment

    Objective response rate

Secondary outcomes

  1. DoR

    Time frame: study data collection expected to last for ~2 years

    Duration of response

  2. PFS

    Time frame: expected to last for ~2 years

    Progression free survival

  3. 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

  4. OS

    Time frame: study data collection expected to last for ~2 years

    Overall suvival

  5. 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

  6. Trough (Cmin) level of fluzoparib concentrations

    Time frame: Cycle 1 to cycle 4(each cycle is 28 days)

    Cssmin of fluzoparib concentrations

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 26, 2018
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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