BAY 43-9006 in Treating Patients With Imatinib Mesylate-Resistant Chronic Phase Chronic Myelogenous Leukemia
Recruitment status was Active, not recruiting
RATIONALE: BAY 43-9006 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well BAY 43-9006 works in treating patients with imatinib mesylate-resistant chronic phase chronic myelogenous leukemia.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
|Study Start Date:||March 2004|
- 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.
- 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.
- 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.
|United States, California|
|Jonsson Comprehensive Cancer Center, UCLA|
|Los Angeles, California, United States, 90095-1678|
|Principal Investigator:||Ronald Paquette, MD||Jonsson Comprehensive Cancer Center|