Status:
COMPLETED
Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Advanced Solid Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15.
Detailed Description
Participants will take GW572016 by mouth daily each cycle (cycles 28 days in length) and will be given Topotecan intravenously on Days 1, 8 and 15. During Cycle 1 participants will be required to spen...
Eligibility Criteria
Inclusion
- Age 18 and older Histologic proof of cancer that is unresectable ANC greater than 1500 u/L PLC greater than 100,000 u/L Total bilirubin less then or equal to ULN AST less than 3 x ULN or AST less than 5 x ULN if liver involvement Creatinine less than 1.5 x ULN Hemoglobin greater than 9 g/dL Echocardiogram with ejection fraction great than 40% Life expectancy of more than 12 weeks
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00295243
Start Date
September 1 2004
End Date
November 1 2006
Last Update
January 13 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905