Status:
COMPLETED
Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
Lead Sponsor:
GlaxoSmithKline
Conditions:
Thrombocytopaenia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ADRIA...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00358540
Start Date
June 1 2006
End Date
October 22 2010
Last Update
November 13 2017
Active Locations (7)
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1
GSK Investigational Site
Santa Monica, California, United States, 90403
2
GSK Investigational Site
Miami, Florida, United States, 33136
3
GSK Investigational Site
Tampa, Florida, United States, 33612
4
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106