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| Name | Class |
|---|---|
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| Tianjin Medical University Second Hospital | OTHER |
| Tianjin Third Central Hospital | OTHER |
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To evaluate the efficacy and safety of eltrombopag to treat chemotherapy-induced thrombocytopenia in solid tumors
This is a single-arm study to evaluate the safety and efficacy of eltrombopag to treat chemotherapy-induced thrombocytopenia(CIT). 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 eltrombopag from week 1 to week 24, and observe incidence of adverse events during the treatment of eltrombopag.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 in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of eltrombopag treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 subjects with chemotherapy-induced thrombocytopenia | Experimental | 50 enrolled subjects will be picked up to take eltrombopag at the indicated dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eltrombopag | Drug | The subjects will initiate treatment with 75 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 75 mg daily. Subjects whose platelet count ≤100×109/L,the eltrombopag dose will maintain. If platelet count >100×109/L for 2 weeks, the subjects need to reduce the dose of eltrombopag 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 eltrombopag to 25mg once every other day during the treatment period, eltrombopag 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 eltrombopag if the platelet is greater than 50×109/L. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the platelet counts after the treatment of eltrombopag | The investigator will assess the changes of the platelet counts after the treatment of eltrombopag from week 1 to week 24. | 24 weeks |
| Incidence of adverse events after the treatment of eltrombopag | The investigator will observe incidence of adverse events after the treatment of eltrombopag, including thrombosis, diarrhea, skin rash, abnormal liver function and so on. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 eltrombopag,if necessary | 24 weeks |
| Changes of concentration of TPO antibodies in peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunfei Chen, MD | Contact | +86-22-23909009 | chenyunfei@ihcams.ac.cn | |
| Lei Zhang, MD | Contact | +86-22-23909240 | zhanglei1@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Lei Zhanglei, MD | Chinese Academy of Medical Science and Blood Disease Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Science and Blood Disease Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25165041 | Background | Winer 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. | |
| 28864871 |
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Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
From 12 months 36 months after study completion.
Upon request to PI.
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| Tianjin People's Hospital |
| OTHER |
| Henan Cancer Hospital | OTHER_GOV |
| The Second Affiliated Hospital of Kunming Medical University | OTHER |
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The investigator will observe the concentration of antibodies in peripheral blood ,if necessary |
| 24 weeks |
| Changes of concentration of anti-c-Mpl antibodies in peripheral blood | The investigator will observe the concentration of antibodies in peripheral blood ,if necessary | 24 weeks |
| Changes of concentration of TPO neutralizing antibodies in peripheral blood | The investigator will observe the concentration of antibodies in peripheral blood ,if necessary | 24 weeks |
| Winer 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. |