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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: | NCT00345826 |
RATIONALE: Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects of dasatinib in treating patients with chronic myelogenous leukemia or acute lymphoblastic leukemia.
Condition | Intervention | Phase |
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Leukemia |
Drug: dasatinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Subjects Who Experienced Clinical Benefit on Protocol CA 180-002 |
Estimated Enrollment: | 54 |
Study Start Date: | November 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, roll-over study of protocol UCLA-0303035.
Patients receive oral dasatinib once or twice daily for 5, 6, or 7 days. Treatment repeats every 7 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 54 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:
Diagnosis of one of the following hematologic malignancies:
Chronic phase chronic myelogenous leukemia (CML)
In complete hematologic response after treatment on protocol UCLA-0303035, as indicated by the following criteria:
Accelerated or blastic phase CML or acute lymphoblastic leukemia
In major hematologic response* after treatment on protocol UCLA-0303035, defined as 1 of the following:
In complete hematologic response*, as indicated by the following criteria:
No evidence of leukemia, as indicated by the following criteria:
In minor hematologic response* after treatment on protocol UCLA-0303035, as indicated by the following criteria:
PATIENT CHARACTERISTICS:
No history of the following significant bleeding disorders unrelated to CML:
PRIOR CONCURRENT THERAPY:
No concurrent use of the following drugs that may confer risk of torsades de pointes:
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 |
Principal Investigator: | Charles Sawyers, MD | Jonsson Comprehensive Cancer Center |
Study ID Numbers: | CDR0000480396, UCLA-0509010-01, BMS-CA180039 |
Study First Received: | June 28, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00345826 |
Health Authority: | United States: Federal Government |
accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia |
relapsing chronic myelogenous leukemia recurrent adult acute lymphoblastic leukemia Philadelphia chromosome positive chronic myelogenous leukemia |
Philadelphia Chromosome Blast Crisis Leukemia, Lymphoid Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Chronic myelogenous leukemia Hematologic Diseases Myeloproliferative Disorders Leukemia, Myeloid Leukemia, Myeloid, Chronic-Phase |
Recurrence Acute lymphoblastic leukemia, adult Leukemia Lymphatic Diseases Leukemia, Myeloid, Accelerated Phase Dasatinib Leukemia, Myelogenous, Chronic, BCR-ABL Positive Bone Marrow Diseases Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases |
Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |