Purpose

The purpose of this study is to see what effect an investigational drug (BMS-354825) has on subjects who are in chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph CML), who are either resistant to high dose imatinib mesylate (Gleevec) or not tolerant of imatinib. Other purposes of the study are to see what side effects this drug may have on subjects, to study the level of BMS-354825 in the blood, and if BMS-354825 is effective in treating leukemia.


Condition Intervention Phase
Chronic Myeloid Leukemia
Philadelphia-Positive Myeloid Leukemia
 Drug: dasatinib
 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, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Major cytogenetic response (MCyR) rate in imatinib resistant patients [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Major cytogenetic response (MCyR) rate in imatinib intolerant patients [ Time Frame: 3 years ]
  • complete hematologic response (CHR) rate [ Time Frame: 3 years ]
  • major molecular response rate (MMoR) [ Time Frame: 3 years ]
  • assessment of health-related quality of life [ Time Frame: 3 years ]
  • assessment of safety and tolerability of BMS-354825 [ Time Frame: 3 years ]
  • pharmacokinetic analysis of BMS-354825 for population pharmacokinetic modeling [ Time Frame: day 8 pf study ]

Enrollment:   424
Study Start Date:   February 2005
Study Completion Date:   April 2008
Primary Completion Date:   April 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: dasatinib
tablets, Oral, 70 mg BID, twice daily, depending on response

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

Criteria

Inclusion Criteria:

  • Open to subjects 18 years of age and over.
  • Subjects with chronic phase Ph CML.
  • Subjects must have previously been treated with imatinib at a dose of >600 mg/day AND developed progressive disease while receiving imatinib at that dose; OR
  • Have CML with resistance to imatinib less than or equal to 600 mg/day with genetic mutation in the BCR-ABL gene that is associated with a high level of resistance to imatinib; OR
  • Be intolerant of imatinib at any dose.
  • Demonstrate adequate organ function.
  • Women able to bear children must have a negative serum or urine pregnancy test. Adequate methods of contraception need to be used throughout the study, to avoid pregnancy for the entire interval of at least 1 month before and 3 months after completion of the study medication.

Exclusion Criteria:

  • Woman 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.
  • Previous diagnosis of accelerated phase or blast crisis CML.
  • Subjects who are eligible and willing to undergo transplantation during the screening period.
  • Uncontrolled or significant cardiovascular disease.
  • Use of Imatinib within 7 days.
  • Use of interferon or cytarabine within 14 days.
  • Use of a targeted small molecule anti-cancer agent within 14 days.
  • Subjects who are taking certain medication that are accepted to have a risk of causing Torsade de Pointes.
  • Subjects taking certain 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: NCT00101660

 Show 85 Study Locations

Sponsors and Collaborators
Bristol-Myers Squibb

Investigators
Study Director:     Bristol-Myers Squibb     Bristol-Myers Squibb    
Bristol-Myers Squibb
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:   CA180-013
First Received:   January 12, 2005
Last Updated:   June 27, 2008
ClinicalTrials.gov Identifier:   NCT00101660
Health Authority:   United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Chronic phase Philadelphia chromosome chronic myeloid leukemia (Ph CML)  

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
Enzyme Inhibitors
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Protein Kinase Inhibitors
Pharmacologic Actions
Translocation, Genetic

Source: National Library of Medicine (NLM) July 10, 2008

  


 
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