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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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06036966
Collaborator
(none)
34
Enrollment
1
Arm
21.9
Anticipated Duration (Months)

Study Details

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）.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
Anticipated Study Start Date :
Sep 16, 2023
Anticipated Primary Completion Date :
Jul 15, 2025
Anticipated Study Completion Date :
Jul 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Hetrombopag

single-arm

Drug: Hetrombopag
All the enrolled 34 patients will be given hetrombopag 5mg per day for 8 weeks when they start to take Niraparib as maintenance therapy

Outcome Measures

Primary Outcome Measures

  1. efficacy of hetrombopag [from the date of recruitment to the time of 12 weeks]

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

Secondary Outcome Measures

  1. incidence of Niraparib suspension [from the date of recruitment to the time of 12 weeks]

    incidence of Niraparib suspension due to thrombocytopenia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age 18-75 years;

  2. Ovarian cancer patients using niraparib as maintenance therapy;

  3. Estimated survival≥ 12 weeks;

  4. Eastern Cooperative Oncology Group Physical Score(ECOG PS) : 0-2;

  5. Adequate function of organs:

(1) Platelet count 100-300109/L, neutrophil count≥2.0109/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:

  1. Patients with the following hematopoietic system diseases: leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc;

  2. Thrombocytopenia caused by non-anti-tumor therapy within 6 months before screening, including chronic liver disease, hypersplenism, infection and bleeding, etc;

  3. 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;

  4. Patients with antiphospholipid syndrome;

  5. Platelet transfusion or used TPO-RA, rhTPO and other platelet-raising drugs within 3 days before screening;

  6. Patients with known or expected hypersensitivity or intolerance to the active ingredient or excipients of Hetrombopag

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Jing Li, Doctor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT06036966
Other Study ID Numbers:
  • SYSKY-2023-764-02
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Niraparib
Hetrombopag
Primary prevention
Additional relevant MeSH terms:
Thrombocytopenia

Study Results

No Results Posted as of Sep 14, 2023