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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
GSK Investigational Site
Santa Monica, California, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Tampa, Florida, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters
Time frame: Approximately 42 weeks
OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir
Time frame: Approximately 18 weeks
Eltrombopag AUC(0-t)
Time frame: Approximately 4 weeks
Doxorubicin and doxorubicinol PK
Time frame: Approximately 4 weeks
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GSK Investigational Site
Greenville, South Carolina, United States
GSK Investigational Site
Dallas, Texas, United States
GSK Investigational Site
Houston, Texas, United States