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The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Experimental | Group B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide |
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| Group A | Experimental | Group A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eltrombopag | Drug | Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters | Approximately 42 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir | Approximately 18 weeks | |
| Eltrombopag AUC(0-t) | Approximately 4 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Santa Monica | California | 90403 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23564375 | Background | Hayes S, Mudd PN Jr, Ouellet D, Johnson BM, Williams D, Gibiansky E. Population PK/PD modeling of eltrombopag in subjects with advanced solid tumors with chemotherapy-induced thrombocytopenia. Cancer Chemother Pharmacol. 2013 Jun;71(6):1507-20. doi: 10.1007/s00280-013-2150-9. Epub 2013 Apr 6. | |
| 23497336 | Derived |
| Label | URL |
|---|---|
| Results for study 105499 can be found on the GSK Clinical Study Register. | View source |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| Doxorubicin and doxorubicinol PK | Approximately 4 weeks |
| Miami |
| Florida |
| 33136 |
| United States |
| GSK Investigational Site | Tampa | Florida | 33612 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19106 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29605 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Houston | Texas | 77030-4009 | United States |
| Chawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Kamel YM. Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide. BMC Cancer. 2013 Mar 16;13:121. doi: 10.1186/1471-2407-13-121. |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |