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

Sponsored by:	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

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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)

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: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression free and overall survival [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Estimated Enrollment:	606
Study Start Date:	June 2005
Estimated Study Completion Date:	March 2011
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

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

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

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 94 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure 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 of Results:

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.

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-035
Study First Received:	July 21, 2005
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00123487
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

Study placed in the following topic categories:

Philadelphia Chromosome
Blast Crisis
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid

Imatinib
Leukemia
Lymphatic Diseases
Leukemia, Myeloid, Accelerated Phase
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Bone Marrow Diseases
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009