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

• Status: Completed
• Trial end date: 2010-10-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

Criteria

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