A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With 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. 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.
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
find the highest dose of GW572016 and Topotecan that can be safely given together
Charles Erlichman, M.D.
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|