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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00123487
First received: July 21, 2005
Last updated: April 30, 2012
Last verified: February 2012
  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 2

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-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)

Resource links provided by NLM:


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: 81 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free and overall survival [ Time Frame: 81 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 606
Study Start Date: June 2005
Estimated Study Completion Date: April 2013
Primary Completion Date: October 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

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
  • ECOG performance status score 0 - 2

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

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama-Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Loma Linda University Cancer Center
Loma Linda, California, United States, 92354
Ucla Dept. Of Medicine
Los Angeles, California, United States, 90095
United States, District of Columbia
Washington Cancer Institute At Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University Of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University School Of Medicine
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
The University Of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
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-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, Missouri
Washington University School Of Medicine
St. 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, 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, 08901
United States, New York
New York Presbyterian Hospital
New York, New York, United States, 10021
United States, North Carolina
The 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
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
The University Of Texas - M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Argentina
Local Institution
Capital Federal, Buenos Aires, Argentina, 1280
Australia, New South Wales
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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, 5000
Australia, Victoria
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Parkville, Victoria, Australia, 3050
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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Yvoir, Belgium, 5530
Brazil
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Curitiba, Parana, Brazil, 80060
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Rio De Janeiro, Rj, Brazil, 20230
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Campinas, Sao Paulo, Brazil, 13083
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Morumbi, Sao Paulo, Brazil, 05652
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Sao Paulo, Brazil, 05403
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Quebec
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Montreal, Quebec, Canada, H3A 1A1
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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Caen Cedex, France, 14033
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Creteil Cedex, France, 94010
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Grenoble Cedex 9, 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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Pessac, France, 33604
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Pierre Benite, France, 69495
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Poitiers Cedex, France, 86021
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Strasbourg Cedex, France, 67091
Germany
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Dresden, Germany, 01307
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Frankfurt, 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, 68163
Greece
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Athens, Greece, 10676
Hungary
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Budapest, Hungary, 1135
Ireland
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Co Galway, Galway, Ireland
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Dublin, Ireland
Israel
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Ramat-Gan, Israel, 52621
Italy
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Bari, Italy, 70124
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Bologna, Italy, 40138
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Monza, Italy, 20052
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Napoli, Italy, 80131
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Orbassano (To), Italy, 10043
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Roma, Italy, 00144
Korea, Republic of
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Jeollanam-Do, Korea, Republic of
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 137-040
Netherlands
Local Institution
Rotterdam, Netherlands, 3075 EA
Norway
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Trondheim, Norway, 7006
Peru
Local Institution
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
Local Institution
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
Local Institution
Observatory, Western Cape, South Africa, 7925
Spain
Local Institution
Barcelona, Spain, 08036
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Madrid, Spain, 28034
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Madrid, Spain, 28006
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Valencia, Spain, 46009
Sweden
Local Institution
Lund, Sweden, 22185
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Stockholm, Sweden, 171 76
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Umea, Sweden, 901 85
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Uppsala, Sweden, 751 85
Switzerland
Local Institution
Basel, Switzerland, 4031
Taiwan
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Taipei, Taiwan, 100
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Taipei, Taiwan, 112
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Taoyuan, Taiwan, 333
Thailand
Local Institution
Bangkok, Thailand, 10400
United Kingdom
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London, Greater London, United Kingdom, W12 ONN
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Liverpool, Merseyside, United Kingdom, L7 8XP
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Glasgow, Scotland, United Kingdom, G12 OXB
Local Institution
Newcastle, Tyne And Wear, United Kingdom, NE2 4HH
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: NCT00123487     History of Changes
Obsolete Identifiers: NCT00331396
Other Study ID Numbers: CA180-035
Study First Received: July 21, 2005
Last Updated: April 30, 2012
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

Additional relevant MeSH terms:
Blast Crisis
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid
Leukemia, Myeloid, Accelerated Phase
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Cell Transformation, Neoplastic
Neoplastic Processes
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Disease Attributes
Dasatinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013