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Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085007 |
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.
Condition | Intervention | Phase |
---|---|---|
Leukemia |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
OBJECTIVES:
Primary
Secondary
Tertiary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Documented hematologic resistance to imatinib mesylate after a prior hematologic response to imatinib mesylate administered at doses of at least 400 mg/day for at least 3 months
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center, UCLA | |
Los Angeles, California, United States, 90095-1678 |
Principal Investigator: | Ronald Paquette, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000367117, UCLA-0312018-01, BAYER-10941 |
Study First Received: | June 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00085007 |
Health Authority: | United States: Federal Government |
chronic phase chronic myelogenous leukemia Philadelphia chromosome positive chronic myelogenous leukemia relapsing chronic myelogenous leukemia |
Imatinib Philadelphia Chromosome Leukemia Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders |
Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid Bone Marrow Diseases Sorafenib |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |