Avatrombopag for Chemotherapy-induced Thrombocytopenia

NCT ID: NCT05218226

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-10
• Study Completion Date: 2025-12-31

Brief Summary

To evaluate the efficacy and safety of Avatrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors

Detailed Description

The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）. Due to the late launch of Avatrombopag in China, the investigator also collected the information of Avatrombopag in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）.

This is a single-arm study to evaluate the safety and efficacy of Avatrombopag to treat chemotherapy-induced thrombocytopenia （CIT）in solid tumors. These subjects have been treated with recombinant human thrombopoietin（rhTPO） or interleukin 11（IL-11） before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Avatrombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of Avatrombopag. The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.

Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag or Herombopag treatment in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Avatrombopag treatment.

Conditions

Chemotherapy-induced Thrombocytopenia; Avatrombopag

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

50 subjects with chemotherapy-induced thrombocytopenia

50 enrolled subjects will be picked up to take Avatrombopag at the indicated dose.

Group Type: EXPERIMENTAL

Avatrombopag

Intervention Type: DRUG

The subjects will initiate treatment with 60 mg/d Avatrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 60 mg daily. Subjects whose platelet count ≤100×109/L，the Avatrombopag dose will maintain. If platelet count \>100×109/L for 2 weeks, the subjects need to reduce the dose of Avatrombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of Avatrombopag to 20mg once every other day or lower frequency during the treatment period, Avatrombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off Avatrombopag if the platelet is greater than 50×109/L.

Interventions

Avatrombopag

The subjects will initiate treatment with 60 mg/d Avatrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 60 mg daily. Subjects whose platelet count ≤100×109/L，the Avatrombopag dose will maintain. If platelet count \>100×109/L for 2 weeks, the subjects need to reduce the dose of Avatrombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of Avatrombopag to 20mg once every other day or lower frequency during the treatment period, Avatrombopag can be stopped for observation, until platelet counts fall below 100×109/L. If the subjects do not need further chemotherapy or radiotherapy, the subjects can taper off Avatrombopag if the platelet is greater than 50×109/L.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Aged ≥18 years old, male or female;
• Conform to the diagnostic criteria of chemotherapy-induced thrombocytopenia (CIT); Ineffective after repeated treatment with rhTPO or IL-11；
• Stop radiotherapy or chemotherapy for more than 1 month;
• Platelet counts <30 ×10^9/L, and bleeding tendency;
• Estimated survival period ≥ 6 months；
• People who are willing to sign the informed consent voluntarily and follow the research program.
• Liver and kidney function<1.5×upper limit of normal, qualified for physical examination；
• Subject is practicing an acceptable method of contraception. Women of childbearing potential must have a negative serum pregnancy test in the whole study;

Exclusion Criteria

• Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases；
• Patients with poor compliance;
• Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA;
• Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.
• There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator；
• Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis；
• Those who have received allogeneic stem cell transplantation or organ transplantation in the past；
• Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up；
• Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared；
• Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)；
• Patients with sepsis or patients with other irregular bleeding；
• Patients taking antiplatelet drugs at the same time；
• Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients；
• Pre-existing cardiac disease, including congestive heart failure of New York Heart Association [NYHA] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT >450msec or QTc > 480 for patients with a Bundle Branch Block;
• Researchers believe that patients should not participate in the test of any other condition.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University Second Hospital

OTHER

Sponsor Role: collaborator

Tianjin Third Central Hospital

OTHER

Sponsor Role: collaborator

Tianjin People's Hospital

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

The Second Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Science and Blood Disease Hospital

Locations

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunfei Chen, MD

Role: CONTACT

chenyunfei@ihcams.ac.cn

+8618502220788

Facility Contacts

Yunfei Chen, MD

Role: primary

chenyunfei@ihcams.ac.cn

+86-22-23909009

Other Identifiers

IIT2020014（Avatrombopag）

Identifier Type: -

Identifier Source: org_study_id