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

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Sep 7, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called hetrombopag to help prevent low platelet levels, known as thrombocytopenia, in women with advanced ovarian cancer who are receiving treatment with another drug called niraparib. While niraparib can improve the outlook for patients, it often causes thrombocytopenia in many patients, which can lead to the need to reduce the drug dose or stop treatment altogether. In this study, 34 participants aged between 18 and 75 will take hetrombopag daily for eight weeks while they start their niraparib therapy. The goal is to see how well hetrombopag works in preventing thrombocytopenia during this time.

To be eligible for this trial, participants should have advanced ovarian cancer, be using niraparib, and have a good overall health status. They should also have adequate blood and organ function. However, those with certain blood disorders, recent severe infections, or other specific health issues will not be included. Participants will be monitored for their platelet levels and any side effects during the study, helping researchers understand if hetrombopag can effectively keep platelet levels stable while on niraparib.

Gender

FEMALE

Eligibility criteria

• 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 100-300\*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:
• • 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