Phase I Study of GW572016 With Topotecan to Treat Advanced Solid Malignancies
Phase 1
Completed
- Conditions
- Advanced Solid Malignancies
- Registration Number
- NCT00295243
- Lead Sponsor
- Mayo Clinic
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Learn whether Topotecan changes how the body handles or processes GW572016 find the highest dose of GW572016 and Topotecan that can be safely given together Learn whether GW572016 changes how the body handles or processesTopotecan Learn the side effects of GW572016 and Topotecan when given together
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States