Advanced Solid Malignancies
Conditions
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.
Interventions
DRUGTopotecan
Sponsors
GlaxoSmithKline
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed