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A Trial of Maintenance Treatment With Fluzoparib Versus Placebo in Relapsed Ovarian Cancer Patients

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ClinicalTrials.gov Identifier: NCT03863860
Recruitment Status : Not yet recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
To evaluate the efficacy, safety tolerability of maintenance therapy with Fluzoparib(A PARP inhibitor) versus placebo in Chinese patients with recurrent ovarian cancer who achieved a complete response (CR) or partial response (PR) after platinum-based chemotherapy

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Fluzoparib capsules Drug: Placebo capsules Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Trial of Maintenance Treatment With Fluzoparib Capsules Versus Placebo in Patients With Platinum-sensitive Recurrent Ovarian Cancer
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Fluzoparib capsules, 50mg per capsule
Fluzoparib capsules, PO
Drug: Fluzoparib capsules
Fluzoparib capsules
Other Name: SHR-3162

Placebo Comparator: Placebo capsules, 50mg per capsule
Placebo capsules, PO
Drug: Placebo capsules
Placebo capsule
Other Name: Placebo




Primary Outcome Measures :
  1. Progression free survival(PFS) in relapsed ovarian cancer patients [ Time Frame: up to 2 years ]
    Defined as progression free survival per RECIST 1.1 criteria

  2. Progression free survival(PFS) in relapsed ovarian cancer patients with Breast cancer susceptibility gene(BRCA) mutant [ Time Frame: up to 2 years ]
    Defined as progression free survival per RECIST 1.1 criteria


Secondary Outcome Measures :
  1. PFS by Blinded Independent Review Committee (BIRC) [ Time Frame: up to 2 years ]
    PFS is Progression-Free-Survival per RECIST 1.1 criteria

  2. Time to progression(TTP) by Gynecological Cancer Intergroup(GCIG) CA 125 criteria [ Time Frame: up to 2 years ]
    TTP is Time to Progression

  3. Chemotherapy free interval (CFI) CFI [ Time Frame: up to 2 years ]
    CFI is the time from last platinum dose until initiation of next anticancer therapy (excluding maintenance therapy if used following the penultimate regimen)

  4. overall survival(OS) [ Time Frame: up to 3 years ]
    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

  5. Objective Response Rate [ Time Frame: At baseline,at the time point of every 12 weeks, up to 2 years ]
    Objective Response Rate complete or partial response per RECIST 1.1 criteria

  6. Adverse Events(AEs) and Serious Adverse Events (SAEs) [ Time Frame: from the first drug administration to within 30 days for the last treatment dose ]
    assess the safety and tolerability of Fluzoparib maintenance monotherapy in platinum sensitive relapsed ovarian cancer patients by record the number of Participants with of AEs and SAEs, and the proportion of patients with AEs and SAEs, etc.



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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:

  1. Histologically diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
  2. Completion of ≥2 previous platinum-containing regimens
  3. Complete response (CR) or partial response (PR) achieved with last platinum-based chemotherapy regimen as determined by investigator
  4. Ability to be randomized ≤8 weeks after last dose of platinum

Exclusion Criteria:

  1. Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor
  2. Patients who have received other study drug treatment within 4 weeks prior to the first administration(< 5 elimination half-lives of the study drug molecular targeted anti-cancer drugs).
  3. Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 2 months prior to the first administration.

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): NCT03863860


Contacts
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Contact: Quanren Wang +86 18036618570 wangquanren@hrglobe.cn

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.
Investigators
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Principal Investigator: Lingying Wu Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03863860     History of Changes
Other Study ID Numbers: FZPL-Ⅲ-301-OC
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma