Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With Advanced Solid Malignancies|
- find the highest dose of GW572016 and Topotecan that can be safely given together
- Learn the side effects of GW572016 and Topotecan when given together
- Learn whether GW572016 changes how the body handles or processesTopotecan
- Learn whether Topotecan changes how the body handles or processes GW572016
|Study Start Date:||September 2004|
|Study Completion Date:||November 2006|
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 spend the evening before Day 1 in the General Clinical Research Center and frequent blood samples will be drawn on Day 1; this schedule will be repeated the evening of Day 6 with the blood samples drawn on Day 7. Participants will have weekly CBCs.