|
|
|
|
|
|
Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112775 |
RATIONALE: BMS-354825 and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This randomized phase II trial is studying BMS-354825 to see how well it works compared to imatinib mesylate in treating patients with chronic phase chronic myelogenous leukemia that did not respond to previous imatinib mesylate.
Condition | Intervention | Phase |
Leukemia |
Drug: dasatinib Drug: imatinib mesylate |
Phase II |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | Imatinib Imatinib mesylate Dasatinib |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Randomized Multi-Center Open Label Study of BMS-354825 vs Imatinib Mesylate (Gleevec®) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Iamtinib at a Dose of 400-600 mg/d |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, randomized, crossover study. Patients are stratified according to study site and cytogenetic response to prior imatinib mesylate (yes vs no). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at day 29, every 4 weeks for 24 weeks, every 12 weeks for the remainder of study treatment, and then at the completion of study treatment.
After the completion of study treatment, patients are followed for at least 30 days.
PROJECTED ACCRUAL: A minimum of 150 patients (100 in arm I and 50 in arm II) will be accrued for this study within 6-12 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of chronic phase chronic myelogenous leukemia (CML), meeting all of the following criteria:
Must have developed resistant disease during prior treatment with imatinib mesylate* at a dose of 400-600 mg/day**, as defined by 1 of the following:
Loss of major cytogenetic response (MCyR)
Loss of complete hematologic response (CHR)
NOTE: **Imatinib mesylate dose ≤ 600 mg/day
Able to tolerate chronic administration of imatinib mesylate at the highest dose received during prior treatment
No previously identified BCR-ABL mutation of 1 of the following types:
No prior diagnosis of accelerated phase or blast crisis CML
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
No history of a significant bleeding disorder unrelated to CML, including any of the following:
Hepatic
Renal
Cardiovascular
No prolonged QTc interval (i.e., > 450 msec) by EKG using Bazett's correction
No history of second or third degree heart block
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
At least 5 days or 5 half-lives (whichever is greater) since prior and no concurrent drugs that carry a risk of causing torsades de Pointes, including any of the following:
At least 5 days or 5 half-lives (whichever is greater) since prior and no concurrent medication that directly inhibits platelet function (except anagrelide for thrombocytosis due to CML), including any of the following:
At least 5 days or 5 half-lives (whichever is greater) since prior and no concurrent anticoagulants (e.g., warfarin, heparin, or low molecular weight heparin [e.g., danaparoid, dalteparin, tinzaparin, or enoxaparin])
No concurrent CYP3A4 inhibitors or inducers, including any of the following:
United States, California | |||||
Jonsson Comprehensive Cancer Center at UCLA | |||||
Los Angeles, California, United States, 90095-1781 |
Jonsson Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Ronald Paquette, MD | Jonsson Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000428457, UCLA-0501047-01, BMS-CA180017, EUDRACT-2004-004450-96 |
First Received: | June 2, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00112775 |
Health Authority: | United States: Federal Government |
|
|
|
|
|