Clinical trial · Interventional
Eltrombopag for Chemotherapy-induced Thrombocytopenia
Eltrombopag for Chemotherapy-induced Thrombocytopenia: a Prospective Multi-center One-arm Study in Solid Tumors
NCT04600960CI-TRIAL-00086332recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Thrombocytopenia | — | UNRESOLVED | — |
| Eltrombopag | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Eltrombopag | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 50 subjects with chemotherapy-induced thrombocytopenia
- description
- 50 enrolled subjects will be picked up to take eltrombopag at the indicated dose.
- interventionNames
- Drug: Eltrombopag
Primary outcomes (2)
- measure
- Changes of the platelet counts after the treatment of eltrombopag
- timeFrame
- 24 weeks
- description
- The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24.
- measure
- Incidence of adverse events after the treatment of eltrombopag
- timeFrame
- 24 weeks
- description
- The investigator will observe incidence of adverse events after the treatment of eltrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDWiner ES, Safran H, Karaszewska B, Richards DA, Hartner L, Forget F, Ramlau R, Kumar K, Mayer B, Johnson BM, Messam CA, Mostafa Kamel Y. Eltrombopag with gemcitabine-based chemotherapy in patients with advanced solid tumors: a randomized phase I study. Cancer Med. 2015 Jan;4(1):16-26. doi: 10.1002/cam4.326. Epub 2014 Aug 28. PMID 25165041
- BACKGROUNDWiner ES, Safran H, Karaszewska B, Bauer S, Khan D, Doerfel S, Burgess P, Kalambakas S, Mostafa Kamel Y, Forget F. Eltrombopag for thrombocytopenia in patients with advanced solid tumors receiving gemcitabine-based chemotherapy: a randomized, placebo-controlled phase 2 study. Int J Hematol. 2017 Dec;106(6):765-776. doi: 10.1007/s12185-017-2319-9. Epub 2017 Sep 1. PMID 28864871