Status:
UNKNOWN
The Efficacy and Safety of Hetrombopag in Primary Prevention of Thrombocytopenia Induced by the Niraparib Maintenance in Advanced Ovarian Cancer Patients
Lead Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions:
Thrombocytopenia
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06036966
Start Date
September 16 2023
End Date
July 15 2025
Last Update
September 14 2023
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