Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide

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

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.

Inclusion criteria:

• Adult subjects, 18 years or older
• Adequate liver and kidney function
• Prior history of ≥grade 2 thrombocytopenia (platelet nadir ≤ 75,000/microliters)
• Ability to ingest and retain oral medication
• Practice acceptable birth control
• Ability to understand and follow study requirements
• Life expectancy of at least 3 months

Exclusion criteria:

• History of platelet disorders, dysfunction, or a bleeding disorder
• Anti-coagulant used within 2 weeks prior to study start
• Females who are lactating or expecting
• History of thromboembolic events or drug induced thrombocytopenia
• History of central nervous system, brain and/or leptomeningeal metastases
• Prior surgery within 2 weeks or radiotherapy within 4 weeks of study start
• Pre-existing cardiac disease