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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03509636
Recruitment Status : Active, not recruiting
First Posted : April 26, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Fluzoparib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 4, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Treatment
Fluzoparib capsule
Drug: Fluzoparib
Fluzoparib capsule will be given twice daily orally
Other Name: SHR-3162




Primary Outcome Measures :
  1. ORR by RECIST v1.1 [ Time Frame: every 8 weeks (±7 days) of treatment ]
    Objective response rate


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509636


Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing, China
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03509636     History of Changes
Other Study ID Numbers: HR-FZPL-Ⅰb-OC
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Ovarian Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type