Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00123474
First received: July 21, 2005
Last updated: August 11, 2014
Last verified: January 2014
  Purpose

This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).


Condition Intervention Phase
Myeloid Leukemia, Chronic, Chronic-Phase
Drug: dasatinib
Phase 3

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-by-Two, Multicenter, Open-Label Phase III Study of BMS-354825 Administered Orally at a Dose of 50 mg or 70 mg Twice Daily or 100 mg or 140 mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome or BCR-ABL Positive Chronic Myelogenous Leukemia Who Are Resistant or Intolerant to Imatinib Mesylate (Gleevec)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare the efficacy of BMS-354825 as defined by MCyR when administered QD relative to BMS-354825 administered BID in the treatment of CP CML imatinib-resistant subjects [ 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 ]
  • Comparison of Major Cytogenetic Response rate between two dose levels [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 651
Study Start Date: July 2005
Study Completion Date: July 2014
Primary Completion Date: September 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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic 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 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
  • Subjects who are eligible and willing to undergo transplantation during the screening period
  • 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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00123474

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Central Hematology Oncology Medical Group Inc.
Alhambra, California, United States, 91801
Pacific Cancer Medical Center Inc
Anaheim, California, United States, 92801
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
Pacific Shores Medical Group
Long Beach, California, United States, 90813
Ucla Dept. Of Medicine
Los Angeles, California, United States, 90095
Ventura County Hematology-Oncology Specialists
Oxnard, California, United States, 93030
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
United States, District of Columbia
Georgetown University Med Ctr
Washington, District of Columbia, United States, 20007
Washington Cancer Institute At Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University Of Florida
Gainesville, Florida, United States, 32610
University Of Miami
Miami, Florida, United States, 33136
Md Anderson Cancer Center Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Georgia Cancer Specialists
Atlanta, Georgia, United States, 30341
Emory University School Of Medicine
Atlanta, Georgia, United States, 30322
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, United States, 30046
United States, Illinois
University Of Chicago
Chicago, Illinois, United States, 60637
Northwestern University Feinberg School Of Medicine
Chicago, Illinois, United States, 60611
Oncology Hematology Associates Of Central Illinois, Pc
Peoria, Illinois, United States, 61615
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University Of Kansas Medical Center
Westwood, Kansas, United States, 66205
United States, Kentucky
University Of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
University Of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Faber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School Of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Devetten, Marcel
Omaha, Nebraska, United States, 68198
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New Jersey
The Cancer Center At Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
The Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
United States, North Carolina
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, United States, 15224
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Ut Southwestern Medical Center
Dallas, Texas, United States, 75390
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Argentina
Local Institution
La Plata, Buenos Aires, Argentina, 1900
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Buenos Aires, Argentina, 1221
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Capital Federal, Argentina, 1280
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Cordoba, Argentina, X5016KEH
Australia, New South Wales
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Camperdown, New South Wales, Australia, 2050
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St Leonards, New South Wales, Australia, 2065
Australia, Queensland
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South Brisbane, Queensland, Australia, 4101
Australia, South Australia
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Adelaide, South Australia, Australia, SA 5000
Australia, Victoria
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East Melbourne, Victoria, Australia, 3002
Australia, Western Australia
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Perth, Western Australia, Australia, WA 6000
Austria
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Wien, Austria, 1090
Belgium
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B-leuven, Belgium, 3000
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Brugge, Belgium, 8000
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Bruxelles, Belgium, 1000
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Charleroi, Belgium, 6000
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Edegem, Belgium, 2650
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Yvoir, Belgium, 5530
Brazil
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Curitiba, Parana, Brazil, 80060
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CEP - Campinas, Brazil, 13083
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Rio de Janeiro, Brazil, 20231
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San Paulo, Sp, Brazil, 05403
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Sao Paulo, Brazil, 05652
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
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Montreal, Quebec, Canada, H2W 1S6
Czech Republic
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Brno, Czech Republic, 625 00
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Prague 2, Czech Republic, 128 20
Denmark
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Aarhus C, Denmark, 8000
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Herlev, Denmark, 2730
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Odense C, Denmark, 5000
Finland
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Helsinki, Finland, 00029
France
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Cedex, Pierre Benite, France, 69495
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Caen, France, 14000
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Creteil Cedex, France, 94010
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Grenoble Cedex 09, France, 38043
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Lille Cedex, France, 59037
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Marseille Cedex 9, France, 13273
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Nantes, France, 44000
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Paris Cedex 10, France, 75475
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Poitiers Cedex, France, 86021
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Strasbourg, France, 67091
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Toulouse Cedex 9, France, 31059
Germany
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Dresden, Germany, 01307
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Frankfurt/main, Germany, 60590
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Hamburg, Germany, 20246
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Leipzig, Germany, 04103
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Mainz, Germany, 55131
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Mannheim, Germany, 68167
Hungary
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Budapest, Hungary, 1135
Ireland
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Co Galway, Galway, Ireland
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Dublin, Ireland, 8
Israel
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Ramat-gan, Israel, 52621
Italy
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Bari, Italy, 70124
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Monza (mi), Italy, 20052
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Napoli, Italy, 80131
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Orbassano, Italy, 10043
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Roma, Italy, 00161
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Roma, Italy, 00144
Korea, Republic of
Local Institution
Jeollanam-do, Korea, Republic of, 519-809
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Kyunggi-do, Korea, Republic of, 480-130
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 110-744
Mexico
Local Institution
Distrito Federal, Mexico, 02990
Netherlands
Local Institution
Nijmegen, Netherlands, 6525 GA
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Rotterdam, Netherlands, 3075 EA
Norway
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Trondheim, Norway, 7006
Peru
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Jesus Maria, Lima, Peru, 11
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Lima, Peru, 34
Philippines
Local Institution
Quezon City, Philippines, 1102
Poland
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Gdansk, Poland, 80 211
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Katowice, Poland, 40032
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Krakow, Poland, 31501
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Lodz, Poland, 93510
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Lublin, Poland, 20 950
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Warsaw, Poland, 02097
Russian Federation
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Moscow, Russian Federation, 125167
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St.petersburg, Russian Federation, 197022
Singapore
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Singapore, Singapore, 169608
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9301
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Groenkloof, Gauteng, South Africa, 0181
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Parktown, Gauteng, South Africa, 2193
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Soweto, Gauteng, South Africa, 2013
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Observatory, Western Cape, South Africa, 7925
Spain
Local Institution
Madrid, Spain, 28034
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Madrid, Spain, 28006
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Pamplona, Spain, 31008
Sweden
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Lund, Sweden, 22185
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Uppsala, Sweden, 751 85
Switzerland
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Basel, Switzerland, 4031
Taiwan
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Taipei, Taiwan, 100
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Taoyuan County, Taiwan, 333
United Kingdom
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Cambridge, Cambridgeshire, United Kingdom, CB2 2XY
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London, Greater London, United Kingdom, W12 OHS
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Liverpool, Merseyside, United Kingdom, L7 8XP
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Newcastle, Tyne And Wear, United Kingdom, NE2 2DR
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Birmingham, West Midlands, United Kingdom, B15 2TH
Local Institution
Glasgow, United Kingdom, G12 0ZD
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00123474     History of Changes
Other Study ID Numbers: CA180-034
Study First Received: July 21, 2005
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Chronic Phase Chronic Myelogenous Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid, Chronic-Phase
Philadelphia Chromosome
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Disease Attributes
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014