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

Completed · Phase 1

Conditions studied: Thrombocytopaenia

In brief

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.

Key facts

Study ID

NCT00358540

Run by

GlaxoSmithKline

People needed

18

Starts

2006-06-01

Expected to finish

2010-10-22

Last updated by the study team

2017-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• GSK Investigational Site — Greenville, South Carolina, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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