Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00123487

Purpose

This is a phase II study of BMS-354825 in subjects with chronic myelogenous leukemia in accelerated phase, or in myeloid or lymphoid blast phase or with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia who are resistant or intolerant to imatinib mesylate (Gleevec).

Condition	Intervention	Phase
Myeloid Leukemia, Chronic, Accelerated Phase Leukemia, Lymphoblastic, Acute, Philadelphia-Positive	Drug: dasatinib	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Two-Arm, Multicenter, Open-Label Phase II Study of BMS-354825 Administered Orally at a Dose of 70 mg Twice Daily or 140 mg Once Daily in Subjects With Chronic Myeloid Leukemia in Accelerated Phase or in Myeloid or Lymphoid Blast Phase or With Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome tetrasomy 18p

MedlinePlus related topics: Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Chronic Myeloid Leukemia Leukemia

Drug Information available for: Dasatinib

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To estimate the Complete Hematological Response rate of 70 and 140 mg of BMS-354825 in patients who have primary or acquired resistance to imatinib [ Time Frame: 81 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free and overall survival [ Time Frame: 81 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	606
Study Start Date:	June 2005
Estimated Study Completion Date:	April 2013
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: dasatinib Tablets, Oral, 50 mg BID, indefinitely, survival study Other Names: Sprycel BMS-354825
Experimental: 2	Drug: dasatinib Tablets, Oral, 70 mg BID, indefinitely, survival study Other Names: Sprycel BMS-354825
Experimental: 3	Drug: dasatinib Tablets, Oral, 100 mg QD, indefinitely, survival study Other Names: Sprycel BMS-354825
Experimental: 4	Drug: dasatinib Tablets, Oral, 140 mg QD, indefinitely, survival study Other Names: Sprycel BMS-354825

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with Ph+ (or BCR/ABL+) accelerated phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate
Men and women, 18 years of age or older
Adequate hepatic function
Adequate renal function
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized
ECOG performance status score 0 - 2

Exclusion Criteria:

Women who are pregnant or breastfeeding
A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
Uncontrolled or significant cardiovascular disease
Medications that increase bleeding risk
Medications that change heart rhythms
Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
History of significant bleeding disorder unrelated to CML
Concurrent incurable malignancy other than CML
Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy
Prior therapy with BMS-35425
Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123487

Show 119 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications:

Chu SC, Tang JL, Li CC. Dasatinib in chronic myelogenous leukemia. N Engl J Med. 2006 Sep 7;355(10):1062-3; author reply 1063-4. No abstract available.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lilly MB, Ottmann OG, Shah NP, Larson RA, Reiffers JJ, Ehninger G, Müller MC, Charbonnier A, Bullorsky E, Dombret H, Brigid Bradley-Garelik M, Zhu C, Martinelli G. Dasatinib 140 mg once daily versus 70 mg twice daily in patients with Ph-positive acute lymphoblastic leukemia who failed imatinib: Results from a phase 3 study. Am J Hematol. 2010 Mar;85(3):164-70.

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00123487 History of Changes
Obsolete Identifiers:	NCT00331396
Other Study ID Numbers:	CA180-035
Study First Received:	July 21, 2005
Last Updated:	February 2, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Accelerated Phase Chronic Myeloid Leukemia
Lymphoid Blast Phase Chronic Myeloid Leukemia
Myeloid Blast Phase Chronic Myeloid Leukemia
Philadelphia Positive Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Blast Crisis
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases

Hematologic Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Disease Attributes
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012