Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study.
Eric S Winer, Howard Safran, Boguslawa Karaszewska...
https://pubmed.ncbi.nlm.nih.gov/25165041Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04600960
Eltrombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
T
Tianjin Medical University Cancer Institute and Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating eltrombopag for treating chemotherapy-induced thrombocytopenia (CIT) in patients with solid tumors. This single-arm phase 2 study focuses on patients whose platelet counts did not respond adequately to previous treatments like recombinant human thrombopoietin (rhTPO) or interleukin 11 (IL-11). The goal is to assess the efficacy and safety of eltrombopag in raising platelet counts and managing related adverse events. Participants will receive eltrombopag starting at 75 mg daily, with weekly platelet count monitoring to guide dose adjustments. The maximum daily dose will not exceed 75 mg. If platelet counts stay above 100 x 10^9/L for two weeks, the dose is reduced; if counts remain high for four weeks at a low dose, treatment may be paused. Treatment can be tapered off if chemotherapy or radiotherapy is no longer needed and platelet counts remain above 50 x 10^9/L. The study includes a 24-week treatment period with safety visits weekly for four weeks after treatment ends or withdrawal. Participants will have regular assessments of platelet counts and monitoring for adverse events throughout the 24 weeks. Additional blood tests will measure concentrations of thrombopoietin and related antibodies. Safety visits occur weekly for a month after treatment to observe any side effects. Researchers will compare the results to historical or concurrent patients receiving supportive care to evaluate eltrombopag's impact on platelet counts and safety in this patient group.
CONDITIONS
Brief Title
Eltrombopag for Chemotherapy-induced Thrombocytopenia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older, male or female
- Diagnosed with chemotherapy-induced thrombocytopenia (CIT)
- Platelet counts below 30 x 10^9/L with bleeding tendency
- Ineffective platelet response after repeated treatment with rhTPO or IL-11
- Stopped radiotherapy or chemotherapy for more than 1 month
- Estimated survival of at least 6 months
- Willing to sign informed consent and follow study procedures
- Liver and kidney function less than 1.5 times the upper normal limit
- Practicing acceptable contraception; women of childbearing potential must have negative pregnancy tests throughout the study
You will not qualify if you...
- Uncontrolled major organ diseases such as extensive metastasis, liver failure, heart failure, or kidney failure
- Poor compliance with study requirements
- Positive tests for HIV, hepatitis B, C, or D, Syphilis, Epstein-Barr Virus DNA, or Cytomegalovirus DNA
- Severe bleeding events like hemoptysis, gastrointestinal bleeding, or intracranial hemorrhage
- Current heart disease needing treatment or uncontrolled hypertension
- History of thrombotic diseases including pulmonary embolism, thrombosis, or atherosclerosis
- Past allogeneic stem cell or organ transplantation
- Mental disorders preventing informed consent or study participation
- Unresolved toxic symptoms from prior treatments
- Other serious diseases limiting trial participation (e.g., diabetes, severe heart failure, unstable angina, gastric ulcers, autoimmune diseases)
- Sepsis or irregular bleeding
- Concurrent use of antiplatelet drugs
- Pregnant, breastfeeding, or suspected pregnancy
- Pre-existing cardiac disease with serious heart failure, arrhythmia needing treatment, recent myocardial infarction, or certain QT abnormalities
- Any condition judged by researchers as unsuitable for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 weeks
Participants receive eltrombopag treatment with dose adjustments based on weekly platelet counts to manage chemotherapy-induced thrombocytopenia.
Weekly visits for up to 24 weeks
Follow-up
Duration - 4 weeks
Participants complete weekly safety visits for up to 4 weeks after ending or withdrawing from eltrombopag treatment to monitor adverse events.
Weekly visits for 4 weeks
Trial Site Locations
Total: 1 location
1
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
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Research Team
Y
Yunfei Chen, MD
L
Lei Zhang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Eltrombopag for thrombocytopenia in patients with advanced solid tumors receiving gemcitabine-based chemotherapy: a randomized, placebo-controlled phase 2 study.
Eric S Winer, Howard Safran, Boguslawa Karaszewska...
https://pubmed.ncbi.nlm.nih.gov/28864871