Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: GlaxoSmithKline
• Treatments: Lapatinib; Topotecan

Criteria

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