Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sarcoma; Thrombocytopenia; Thrombopoiesis
Intervention: eltrombopag (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718
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.
Clinical Details
Official title: 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
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Primary outcome: Safety and tolerability
Secondary outcome: Optimal biological dose, Pharmacokinetics
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718
GSK Investigational Site, Santa Monica, California 90403, United States; Withdrawn
GSK Investigational Site, Santa Monica, California 90403, United States; Recruiting
GSK Investigational Site, Philadelphia, Pennsylvania 19106, United States; Recruiting
GSK Investigational Site, Philadelphia, Pennsylvania 19106, United States; Withdrawn
GSK Investigational Site, Houston, Texas 77030-4009, United States; Completed
GSK Investigational Site, Houston, Texas 77030-4009, United States; Withdrawn
Additional Information
Starting date: June 2006
Last updated: October 15, 2009
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