Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia - Full Text View

Purpose

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Condition	Intervention	Phase
Chronic Myeloid Leukemia Philadelphia-Positive Myeloid Leukemia	Drug: Dasatinib Drug: Imatinib	Phase II

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic

ChemIDplus related topics:

Imatinib Imatinib mesylate Dasatinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

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 Imatinib at a Dose at 400 - 600 mg/d

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To estimate the major cytogenetic response (MCyR) rates of BMS-354825 and imatinib at 800 mg daily [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and Efficacy [ Time Frame: continuously throughout the study ] [ Designated as safety issue: Yes ]

Enrollment:	151
Study Start Date:	February 2005
Study Completion Date:	March 2008
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Active Comparator	Drug: Dasatinib Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks
2: Experimental Active Comparator	Drug: Imatinib Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men and women, 18 years of age or older.
Subjects with Chronic Phase Ph+ CML.
Subjects have not been treated with imatinib at a dose >600 mg/day.
Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day.
Able to tolerate imatinib at the highest dose the subject had received in the past.
Demonstrate adequate renal and hepatic function.
Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.

Exclusion Criteria:

Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
Women using a prohibited contraceptive method.
Women who are pregnant or breastfeeding.
Men whose sexual partners are women who are of childbearing potential, and who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period as outlined above.
Prior treatment with imatinib at a dose >600 mg/day.
Subjects who have previously identified specific BCR-ABL mutations.
Previous diagnosis of accelerated phase or blast crisis CML.
Intolerance to imatinib at any dose.
Subjects who are eligible and willing to undergo transplantation during the screening period.
Serious uncontrolled medical disorder or active infection.
Uncontrolled or significant cardiovascular disease.
Uncontrolled hypertension.
Dementia or altered mental status.
Evidence of organ dysfunction.
Use of imatinib within 7 days.
Use of interferon or cytarabine within 14 days.
Use of a targeted small molecule anticancer agent within 14 days.
Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
Prior therapy with BMS-354825.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00103844

Show 132 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	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 www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-017
First Received:	February 15, 2005
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00103844
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Chronic Phase Philadelphia chromosome Positive (Ph+) chronic myeloid leukemia

Study placed in the following topic categories:

Imatinib

Chromosomal abnormalities

Philadelphia Chromosome

Leukemia

Chronic myelogenous leukemia

Hematologic Diseases

Dasatinib

Chromosome Aberrations

Myeloproliferative Disorders

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Leukemia, Myeloid

Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Protein Kinase Inhibitors

Pharmacologic Actions

Translocation, Genetic

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00103844