Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
- Registration Number
- NCT00358540
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Group A eltrombopag 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. Group B eltrombopag 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
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Eltrombopag AUC(0-t) Approximately 4 weeks Doxorubicin and doxorubicinol PK Approximately 4 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 Approximately 18 weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Houston, Texas, United States