An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen
Overview
- Phase
- Phase 1
- Intervention
- eltrombopag
- Conditions
- Thrombocytopaenia
- Sponsor
- GlaxoSmithKline
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group B
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
Intervention: eltrombopag
Group A
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.
Intervention: eltrombopag
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)