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The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients

Primary Purpose

Thrombocytopenia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hetrombopag
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring Niraparib, Hetrombopag, Primary prevention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Age 18-75 years; Ovarian cancer patients using niraparib as maintenance therapy; Estimated survival≥ 12 weeks; Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2; Adequate function of organs: (1) Platelet count 100-300*109/L, neutrophil count≥2.0*109/L, hemoglobin 100-150g/L; (2) Renal function: Cr≤1.5 upper limit of normal(ULN); (3) Endogenous creatinine clearance (Ccr) ≥ 55 ml/min; (4) Liver function: total bilirubin ≤1.5 upper limit of normal(ULN); (5) Alanine aminotransferase(ALT)and aspartate aminotransferase(AST)≤3 upper limit of normal(ULN); (6) Coagulation function: PT≤1.5 upper limit of normal(ULN); 6. No serious complications (including active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever> 38℃) Exclusion Criteria: Patients with the following hematopoietic system diseases: leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc; Thrombocytopenia caused by non-anti-tumor therapy within 6 months before screening, including chronic liver disease, hypersplenism, infection and bleeding, etc; Imaging examination shows bone marrow invasion or bone marrow metastasis, such as Positron Emission Computed Tomography(PET-CT), Magnetic Resonance Imaging(MRI)or nuclear scan; Patients with antiphospholipid syndrome; Platelet transfusion or used TPO-RA, rhTPO and other platelet-raising drugs within 3 days before screening; Patients with known or expected hypersensitivity or intolerance to the active ingredient or excipients of Hetrombopag

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hetrombopag

    Arm Description

    single-arm

    Outcomes

    Primary Outcome Measures

    efficacy of hetrombopag
    incidence of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)

    Secondary Outcome Measures

    incidence of Niraparib suspension
    incidence of Niraparib suspension due to thrombocytopenia

    Full Information

    First Posted
    September 7, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06036966
    Brief Title
    The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
    Official Title
    The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 16, 2023 (Anticipated)
    Primary Completion Date
    July 15, 2025 (Anticipated)
    Study Completion Date
    July 15, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Niraparib brings a better prognosis to those with advanced ovarian cancer and has been approved by the Food and Drug Administration(FDA )and National Medical Products Administration(NMPA)as one of the maintenance therapies for the advanced ovarian cancer patients. Thrombocytopenia is one of the adverse effects of Niraparib, with a 61% overall incidence and 34% of the grade 3~4 incidence. Thrombocytopenia may cause suspension or dose reduction of Niraparib which will affect the therapeutic effect of the drug. At present, the drugs recommended by the guidelines for the treatment of thrombocytopenia are recombinant thrombopoietin (rhTPO), recombinant interleukin 11 (rhIL-11), TPO receptor agonist (TPO-RA). Hetrombopag is one of the TPO-RA, which is recommended by the Chinese expert consensus to cure the thrombocytopenia caused by poly adenosinediphosphate ribose polymerase(PARP) inhibitors, including Niraparib. However, is it effective when it is used as the primary prevention during the maintenance therapy of Niraparib? This single-arm study aims to explore the efficacy and safety of hetrombopag for the prevention of thrombocytopenia caused by Niraparib maintenance therapy in advanced ovarian cancer patients. 34 patients will be recruited and they will take hetrombopag 5mg per day for 8 weeks when they initiate the maintenance therapy with Niraparib. The primary endpoint of this study is the rate of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thrombocytopenia
    Keywords
    Niraparib, Hetrombopag, Primary prevention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hetrombopag
    Arm Type
    Experimental
    Arm Description
    single-arm
    Intervention Type
    Drug
    Intervention Name(s)
    Hetrombopag
    Intervention Description
    All the enrolled 34 patients will be given hetrombopag 5mg per day for 8 weeks when they start to take Niraparib as maintenance therapy
    Primary Outcome Measure Information:
    Title
    efficacy of hetrombopag
    Description
    incidence of thrombocytopenia according to Common Terminology Criteria for Adverse Events 5.0(CTCAE5.0)
    Time Frame
    from the date of recruitment to the time of 12 weeks
    Secondary Outcome Measure Information:
    Title
    incidence of Niraparib suspension
    Description
    incidence of Niraparib suspension due to thrombocytopenia
    Time Frame
    from the date of recruitment to the time of 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-75 years; Ovarian cancer patients using niraparib as maintenance therapy; Estimated survival≥ 12 weeks; Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2; Adequate function of organs: (1) Platelet count 100-300*109/L, neutrophil count≥2.0*109/L, hemoglobin 100-150g/L; (2) Renal function: Cr≤1.5 upper limit of normal(ULN); (3) Endogenous creatinine clearance (Ccr) ≥ 55 ml/min; (4) Liver function: total bilirubin ≤1.5 upper limit of normal(ULN); (5) Alanine aminotransferase(ALT)and aspartate aminotransferase(AST)≤3 upper limit of normal(ULN); (6) Coagulation function: PT≤1.5 upper limit of normal(ULN); 6. No serious complications (including active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever> 38℃) Exclusion Criteria: Patients with the following hematopoietic system diseases: leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc; Thrombocytopenia caused by non-anti-tumor therapy within 6 months before screening, including chronic liver disease, hypersplenism, infection and bleeding, etc; Imaging examination shows bone marrow invasion or bone marrow metastasis, such as Positron Emission Computed Tomography(PET-CT), Magnetic Resonance Imaging(MRI)or nuclear scan; Patients with antiphospholipid syndrome; Platelet transfusion or used TPO-RA, rhTPO and other platelet-raising drugs within 3 days before screening; Patients with known or expected hypersensitivity or intolerance to the active ingredient or excipients of Hetrombopag
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    miaofang Wu, Doctor
    Phone
    +8613828494674
    Email
    wmiaofang@mail.sysu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    miaofang Wu
    Phone
    +8613828494674
    Email
    wmiaofang@mail.sysu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jing Li, Doctor
    Organizational Affiliation
    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients

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