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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05218226
Other study ID # IIT2020014-EC-3
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 10, 2022
Est. completion date December 31, 2024

Study information

Verified date January 2023
Source Institute of Hematology & Blood Diseases Hospital
Contact Yunfei Chen, MD
Phone +8618502220788
Email chenyunfei@ihcams.ac.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
China Chinese Academy of Medical Science and Blood Disease Hospital Tianjin Tianjin

Sponsors (7)

Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital Henan Cancer Hospital, The Second Affiliated Hospital of Kunming Medical University, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University Second Hospital, Tianjin People's Hospital, Tianjin Third Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes of the platelet counts after the treatment of Avatrombopag The investigator will assess the changes of the platelet counts after the treatment of Avatrombopag from week 1 to week 24,and calculate the proportion of subjects = 30 × 10^9/L , 50 × 10^9/L and 100 × 10^9/L at week 12 and week 24. 24 weeks
Secondary Incidence of adverse events after the treatment of Avatrombopag The investigator will observe incidence of adverse events after the treatment of Avatrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on. 24 weeks
Secondary Changes of concentration of TPO in peripheral blood The investigator will observe the concentration of TPO in peripheral blood before and after the treatment of Avatrombopag, if necessary. 24 weeks
Secondary Changes of concentration of TPO antibodies,anti-c-Mpl antibodies and TPO neutralizing antibodies in peripheral blood The investigator will observe the concentration of antibodies in peripheral blood before and after the treatment of Avatrombopag, if necessary 24 weeks
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05969158 - Hetrombopag in Secondary Prevention of XPO-1 Inhibitor-induced Thrombocytopenia in Lymphoma Phase 2
Active, not recruiting NCT03362177 - Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer Phase 3
Recruiting NCT05554913 - Evaluating the Efficacy and Safety of QL0911 in the Prevention of Chemotherapy- Induced Thrombocytopenia Phase 2/Phase 3
Completed NCT05688306 - To Evaluate Thrombosis Risk in Chemotherapy Patients With Solid Tumors Who Receiving Thrombocytopenia Treatment
Completed NCT00283439 - A Dose and Schedule Finding Trial With AMG 531 for Chemotherapy Induced Thrombocytopenia (CIT) in Adults With Lymphoma Phase 1/Phase 2
Not yet recruiting NCT06099925 - The Efficacy and Safety of Hetrombopag as Secondary Prevention to Chemotherapy-induced Thrombocytopenia in Patients With Gynecologic Malignancies Phase 2
Completed NCT03471078 - Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers Phase 3
Active, not recruiting NCT03976882 - Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy. Phase 3
Recruiting NCT05772546 - Avatrombopag vs. Placebo for CIT in GI Malignancies Phase 2
Not yet recruiting NCT05864014 - Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors. Phase 3
Terminated NCT01345214 - A Study of the Safety and Efficacy of ONO-7746 in Adult Cancer Patients With Chemotherapy Induced Thrombocytopenia Phase 1
Completed NCT01663441 - A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11 Phase 3
Recruiting NCT05236582 - Herombopag for Chemotherapy-induced Thrombocytopenia Phase 2
Not yet recruiting NCT05944211 - Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia(CIT) in Patients With Acute Myeloid Leukemia Phase 2
Withdrawn NCT03343847 - Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Lymphoma. Phase 3
Completed NCT05851027 - Evaluating the Efficacy and Safety of QL0911 in Chemotherapy- Induced Thrombocytopenia Phase 2/Phase 3
Not yet recruiting NCT03049774 - A Study of the Recombinant Human Interleukin-11 (I) (Baijieyi) for Prevention and Treatment of Chemotherapy-induced Thrombocytopenia in Patients With Malignant Tumor N/A
Recruiting NCT03937154 - Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer Phase 3
Recruiting NCT04600960 - Eltrombopag for Chemotherapy-induced Thrombocytopenia Phase 2
Completed NCT00413283 - Dose/ Schedule Finding Trial of Romiplostim for Chemotherapy-Induced Thrombocytopenia (CIT) in Non-Small Cell Lung Cancer (NSCLC) Phase 2