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A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04229615
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Carcinoma Drug: Fluzoparib; Apatinib Drug: Fluzoparib Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Phase III Clinical Trial Evaluating the Efficacy and Safety of Fluzoparib±Apatinib for Maintenance Treatment in Patients With Advanced Ovarian Cancer Who Have Achieved Effective Response After First-line Platinum-containing Chemotherapy
Estimated Study Start Date : February 25, 2020
Estimated Primary Completion Date : August 25, 2022
Estimated Study Completion Date : February 25, 2024


Arm Intervention/treatment
Experimental: Safety Lead-in, Doublet Arm
Fluzoparib+Apatinib
Drug: Fluzoparib; Apatinib
Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily

Experimental: Single Arm
Fluzoparib
Drug: Fluzoparib
Fluzoparib Orally twice daily

Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. (Safety Lead-in) Incidence of ≥3 grade TRAEs [ Time Frame: up to 28 days after the last patient of the lead-in phase ]
    Incidence of ≥3 grade treatment related adverse events

  2. (Phase 3) Progression free survival(PFS) in advanced ovarian cancer patients [ Time Frame: up to 4 years ]
    Defined as progression free survival per RECIST 1.1 criteria according to BIRC criteria


Secondary Outcome Measures :
  1. AEs+SAEs [ Time Frame: from the first drug administration to within 30 days for the last treatment dose ]
    Adverse Events and Serious Adverse Events

  2. PFS by investigator's assessment [ Time Frame: up to 4 years ]
    Progression-Free-Survival

  3. OS [ Time Frame: up to 6 years ]
    OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

  4. Patients reported outcome(PROs)assessed by EQ-5D-5L questionnaire [ Time Frame: 48 months ]
    Comparison of the Quality of Life in study arms assessed by EQ-5D-5L questionnaire

  5. Patients reported outcome(PROs)assessed by FOSI questionnaire [ Time Frame: 48 months ]
    Comparison of the Quality of Life in study arms assessed by FOSI questionnaire

  6. Time to progression on the next anticancer therapy (PFS2) From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first. [ Time Frame: 4 years ]
    From date of start of next anticancer therapy to date of first documented progression of date of death from any cause, whichever comes first.



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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:

  • (phase 3)Histologically new diagnosed, advanced (FIGO Stage III or IV) high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
  • (phase 3)Complete response (CR) or partial response (PR) achieved with front-line platinum-based chemotherapy regimen as determined by investigator
  • (phase 3)Ability to be randomized ≤8 weeks after last dose of platinum
  • (Saftey Lead-in)Received 2~4 prior chemotherapy regimens. Platimun sensitive relapsed; Have at least one measurable disease as defined by RECIST v1.1.

Exclusion Criteria:

  • Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
  • 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).
  • 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): NCT04229615


Contacts
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Contact: Quanren Wang +86 18036618570 wangquanren@hrglobe.cn
Contact: Shuilian Jiang +86 13581558166 jiangshuilian@hrglobe.cn

Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04229615    
Other Study ID Numbers: FZPL-Ⅲ-302
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action