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Efficacy and Safety of Avatrombopag in Patients with Thrombocytopenia of Ovarian Cancer Treated with Niraparib

Efficacy and Safety of Avatrombopag in Patients with Thrombocytopenia of Ovarian Cancer Treated with Niraparib

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064890
Enrollment
Unknown
Registered
2022-10-20
Start date
2022-10-20
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombocytopenia in patients with ovarian cancer

Interventions

Treatment Group :Avatrombopag

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Female, aged >= 18 years; 2. The patients were clinically diagnosed as ovarian cancer, fallopian tube cancer and primary peritoneal cancer; According to the standards of the International Federation of Gynecology and Obstetrics (FIGO), all patients suffered from classified high-grade serous or endometrioid ovarian cancer, primary fallopian tube cancer and primary peritoneal cancer; 3. The patient developed thrombocytopenia of grade 1 or above (platelet count<100 × 10 ^ 9/L), and plans to continue to receive Nilapalide treatment, which requires intervention on patients with thrombocytopenia; 4. The patient's physical status score of the Eastern American Oncology Collaboration Group (ECOG) was 0 or 1; 5. The patient must be able to take drugs orally and be able to complete this clinical research process; 6. Any previous toxicity and side effects of the patient have recovered to the level of CTCAE <= 1 or baseline, except for sensory neuropathy or alopecia with stable symptoms of CTCAE <= 2; 7. Written informed consent should be signed prior to any study related procedures.

Exclusion criteria

Exclusion criteria: 1. The patient was diagnosed with mucinous, clear cell subtypes of epithelial ovarian cancer, carcinosarcoma, or undifferentiated ovarian cancer; 2. Patients who are known to be allergic to the active or inactive ingredients of Nilaparil or to other drugs with a similar chemical structure to Nilaparil; 3. Patients who underwent major surgery 3 weeks before the start of the study, or who were affected by any surgical effects that had not recovered after the surgery; 4. Patients who received >20% bone marrow palliative radiotherapy 3 weeks before enrollment; 5. Patients with invasive cancers other than ovarian cancer (except treated cervical carcinoma in situ, non-melanoma, ductal carcinoma in situ) within 5 years prior to enrollment; 6. Thrombocytopenia caused by drugs other than antitumor therapy, such as antibiotics, heparin, etc.; 7. In addition to malignant tumor (solid tumor), the patient is also complicated with other hematological diseases, including immune thrombocytopenia, aplastic anemia, myelodysplastic syndrome, hematological malignancies, etc.; 8. Patients with chronic liver diseases, including chronic hepatitis B, chronic hepatitis C, alcoholic liver disease, non-alcoholic fatty liver disease, cirrhosis of various causes, liver failure, etc.; 9. The patient had severe acute infection; 10. Patients who are pregnant or nursing, or expect to plan pregnancy during the course of the study treatment; 11. Patients with other serious or uncontrollable diseases, including but not limited to: (1) Uncontrolled nausea and vomiting, inability to swallow the study medication, and any gastrointestinal disorders that may interfere with drug absorption and metabolism; (2) Human immunodeficiency virus (HIV) infection, active hepatitis (hepatitis B, hepatitis C); (3) Uncontrolled ventricular arrhythmias, myocardial infarction occurring within 3 months prior to enrollment; (4) Uncontrollable grand mal epilepsy, unstable spinal cord compression, superior vena cava syndrome, or other mental illness that may affect the patient's ability to sign informed consent; (5) Immune deficiency (other than splenectomy) or other medical conditions, as the researchers believe, may put the patient at high risk; 12. Patients with medical records have participated in any clinical study of any other investigational drug or medical device within 30 days prior to medication, except observational studies; 13. The investigator considers that there are any other factors unsuitable for inclusion or affecting participation in or completion of the study.

Design outcomes

Primary

MeasureTime frame
Routine blood test;

Countries

China

Contacts

Public ContactWu Ming

Peking Union Medical College Hospital

wuming@pumch.cn+86 15210931146

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026