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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Malignancies

Treatments: Drug: Topotecan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00295243

1073-04 (Other Identifier)

MC0315 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)