NCT00295243

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

A Phase I Trial of the Dual Kinase Inhibitor GW572016 in Combination With Topotecan in Patients With Advanced Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Advanced Solid Malignancies

Interventions

Type	Name	Description
DRUG	Topotecan

Timeline

• Start date: 2004-09-01
• Completion: 2006-11-01
• First posted: 2006-02-23
• Last updated: 2011-01-13

Locations

1 site across 1 country: United States