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


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Malignancies

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Trial Information

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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

find the highest dose of GW572016 and Topotecan that can be safely given together

Principal Investigator

Charles Erlichman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

1073-04

NCT ID:

NCT00295243

Start Date:

September 2004

Completion Date:

November 2006

Related Keywords:

  • Advanced Solid Malignancies
  • Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905