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A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

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ClinicalTrials.gov Identifier: NCT04517357
Recruitment Status : Recruiting
First Posted : August 18, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in the Treatment of Relapsed Ovarian Cancer Patients
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Doublet Arm Fluzoparib+Apatinib
Fluzoparib Orally twice daily; Apatinib Orally once daily
Drug: Fluzoparib+Apatinib
Fluzoparib Orally twice daily; Apatinib Orally once daily

Active Comparator: Single Arm Apatinib
Fluzoparib Orally twice daily
Drug: Fluzoparib
Fluzoparib Orally twice daily




Primary Outcome Measures :
  1. (Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle [Time Frame: ] [ Time Frame: up to 28 days ]
  2. (Safety Lead-in) Recommended Phase II Dose (RP2D) of Fluzoparib+Apatinib [ Time Frame: up to 28 days ]
  3. (Phase 2) Progression free survival(PFS) in relapsed ovarian cancer patients [ Time Frame: Radiological scans performed at baseline then every ~8 weeks until objective radiological disease progression. Assessed up to a maximum of 20 months. ]
    Defined as progression free survival per RECIST 1.1 criteria according to Investigator's assessment


Secondary Outcome Measures :
  1. AEs+SAEs [ Time Frame: up to 20 months ]
    from the first drug administration to within 30 days for the last treatment dose


Other Outcome Measures:
  1. Objective Response Rate (ORR) [ Time Frame: up to 20 months ]
    Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI

  2. Disease control rate (DCR) [ Time Frame: up to 20 months ]
    Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

  3. Duration of response (DoR) [ Time Frame: up to 20 months ]
    Time from documentation of tumor response to disease progression assessed among patients who had an objective response

  4. Response rate by GCIG CA125 AND RECIST 1.1 criteria [ Time Frame: up to 20 months ]


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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 diagnosed high-grade serous or endometrioid ovarian cancer (including primary peritoneal and fallopian tube cancer)
  • Completion of ≥2 previous platinum-containing regimens
  • At least one target lesion
  • ECOG performance status 0-1.
  • Adequate bone marrow, kidney and liver function.

Exclusion Criteria:

  • Prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor or Apatinib
  • Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix allowed.
  • Radiation or anti-hormonal therapy or anticancer therapy within 14 days before first administration.
  • Known to be human immunodeficiency virus positive.
  • Known active hepatitis C virus, or known active hepatitis B virus.
  • Untreated and/or uncontrolled brain metastases.
  • Patients with clinical symptoms of cancer ascites, pleural effusion, who need to drainage, or who have undergone ascites drainage within 3 months prior to the first administration.
  • Pregnant or breast-feeding women.

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): NCT04517357


Locations
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China
Jiangsu HengRui Medicine Co., Ltd. Recruiting
Shanghai, China
Contact: quanren Wang    +86 18036618570    wangquanren@hrglobe.cn   
Contact: yuting wang    +86 13166396365    wangyuting@hrglobe.cn   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04517357    
Other Study ID Numbers: FZPL-II-201
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 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
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Apatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action