Advanced Chronic Myelogenous Leukemia (CML) - Follow On: Study of BMS-354825 in Subjects With CML
This study is ongoing, but not recruiting participants.
Sponsor:
Bristol-Myers Squibb
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
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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:
Genetics Home Reference related topics:
tetrasomy 18p
Drug Information available for:
Dasatinib
U.S. FDA Resources
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:
|
| Experimental: 2 |
Drug: dasatinib
Tablets, Oral, 70 mg BID, indefinitely, survival study
Other Names:
|
| Experimental: 3 |
Drug: dasatinib
Tablets, Oral, 100 mg QD, indefinitely, survival study
Other Names:
|
| Experimental: 4 |
Drug: dasatinib
Tablets, Oral, 140 mg QD, indefinitely, survival study
Other Names:
|
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
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| 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 | |
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| Capital Federal, Buenos Aires, Argentina, 1280 | |
| Australia, New South Wales | |
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| St Leonards, New South Wales, Australia, 2065 | |
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| South Brisbane, Queensland, Australia, 4101 | |
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| Adelaide, South Australia, Australia, 5000 | |
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| Parkville, Victoria, Australia, 3050 | |
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| Perth, Western Australia, Australia, WA 6000 | |
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| Wien, Austria, 1090 | |
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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 | |
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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 | |
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| Edmonton, Alberta, Canada, T6G 1Z2 | |
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| Vancouver, British Columbia, Canada, V5Z 1M9 | |
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| Montreal, Quebec, Canada, H3A 1A1 | |
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| Brno, Czech Republic, 625 00 | |
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| Prague 2, Czech Republic, 128 20 | |
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| Aarhus C, Denmark, 8000 | |
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| Herlev, Denmark, 2730 | |
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| Odense C, Denmark, 5000 | |
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| Helsinki, Finland, 00029 | |
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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 | |
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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 | |
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| Athens, Greece, 10676 | |
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| Budapest, Hungary, 1135 | |
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| Co Galway, Galway, Ireland | |
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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 | |
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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 | |
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| Quezon City, Philippines, 1102 | |
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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 | |
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| 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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| Observatory, Western Cape, South Africa, 7925 | |
| Spain | |
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| 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 | |
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| 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 | |
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| 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 | |
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| 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 | |
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| 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