A Study of Dasatinib in Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00482703

Purpose

The objective is to evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase CML by once daily (QD) or twice daily (BID)

Condition	Intervention	Phase
Myeloid Leukemia, Chronic	Drug: Dasatinib Drug: dasatinib	Phase I 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, Multicenter, Open-Label Phase II Study of Dasatinib (BMS-354825) Administered Orally at a Dose of 50mg Twice Daily or 100mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Imatinib

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To evaluate the cytogenetic response to Dasatinib (BMS-354825) administered for 24 weeks in subjects with Imatinib resistant or intolerant chronic phase CML by once daily (QD) or twice daily (BID) [ Time Frame: When 24 weeks observation is done in all subjects ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of Dasatinib (BMS-354825) [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
To evaluate the hematologic response of Dasatinib (BMS-354825) [ Time Frame: When 24 weeks observation is done in all subjects and at the end of study ] [ Designated as safety issue: No ]
To determine the time to and duration of hematologic and cytogenetic response [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
To explore mutations and biochemical assays of BCR-ABL and provide any preliminary evidence of responses [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
To evaluate the pharmacokinetics of Dasatinib (BMS-354825) by population pharmacokinetics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
To evaluate the cytogenetic efficacy in extended period [ Time Frame: at the end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	May 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Dasatinib tablets, Oral, 100 mg, once daily for 24 weeks
B: Experimental	Drug: dasatinib tablets, Oral, 50 mg, twice daily for 24 weeks

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Philadelphia chromosome positive or bcr-abl gene positive Chronic phase Chronic Myelogenous Leukemia (CML) subjects must have primary or acquired resistance to Imatinib mesylate or have intolerance of imatinib mesylate
Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
Men and women, ages 20 to 75
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized

Exclusion Criteria:

Subjects who are eligible and willing to undergo transplantation at pre-study
Women who are pregnant or breastfeeding
Uncontrolled or significant cardiovascular disease
History of significant bleeding disorder unrelated to CML
Adequate hepatic function
Adequate renal function
Medication that increases bleeding risk
Medication that changes heart rhythms
Subjects who are compulsory detained for legal reasons or 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: NCT00482703

Locations

Japan
Local Institution
Kyoto, Japan, --
Japan, Aichi
Local Institution
Nagoya, Aichi, Japan, 464-8681
Japan, Hyogo
Local Institution
Nishinomiya-Shi, Hyogo, Japan, 663-8501
Japan, Kagoshima
Local Institution
Kagoshima-Shi, Kagoshima, Japan, 890-0064
Japan, Kanagawa
Local Institution
Isehara-Shi, Kanagawa, Japan, 259-1193
Japan, Okayama
Local Institution
Okayama-Shi, Okayama, Japan, 700-0082
Japan, Shizuoka
Local Institution
Hamamatsu-Shi, Shizuoka, Japan, 431-3192
Japan, Tokyo
Local Institution
Chuo-Ku, Tokyo, Japan, 104-0045
Local Institution
Bunkyo-Ku, Tokyo, Japan, 113-8677
Local Institution
Shibuya-Ku, Tokyo, Japan, 150-8935

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA180-138
Study First Received:	June 4, 2007
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00482703
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bristol-Myers Squibb:

Imatinib resistant or intolerant chronic phase CML

Study placed in the following topic categories:

Philadelphia Chromosome
Chromosomal abnormalities
Chronic myelogenous leukemia
Hematologic Diseases
Myeloproliferative Disorders
Leukemia, Myeloid
Leukemia, Myeloid, Chronic-Phase

Imatinib
Leukemia
Dasatinib
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chromosome Aberrations
Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action

Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Translocation, Genetic

ClinicalTrials.gov processed this record on January 14, 2009