Open Label Multi-Centric Phase II Study of the Raf Kinase Inhibitor BAY 43-9006 in Chronic Myelogenous Leukemia (CML) Patients Resistant to Gleevec (Imatinib)
OBJECTIVES:
Primary
- Determine the major hematologic response rate (complete and partial response) in
patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia.
- Determine the safety of this drug in these patients.
Secondary
- Determine the cytogenetic response rate in patients treated with this drug.
- Determine the duration of hematologic response in patients treated with this drug.
- Determine the duration of cytogenetic response in patients treated with this drug.
- Determine time to progression in patients treated with this drug.
- Determine overall survival of patients treated with this drug.
Tertiary
- Determined the molecular response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral BAY 43-9006 twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Ronald Paquette, MD
Principal Investigator
Jonsson Comprehensive Cancer Center
United States: Federal Government
CDR0000367117
NCT00085007
March 2004
Name | Location |
---|---|
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |