Study of Dasatinib (BMS-354825) in Patients With Accelerated Phase Chronic Myeloid Leukemia

NCT ID: NCT00101647

Last Updated: 2011-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2008-03-31

Brief Summary

The purpose of this clinical research study is to learn if BMS-354825 will have activity, defined by hematologic response, in subjects who have accelerated phase chronic myeloid leukemia (CML) who are resistant to or intolerant to imatinib mesylate. The safety of this treatment will also be studied.

Conditions

Chronic Myelogenous Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure

Interventions

Dasatinib

Tablets, Oral, 70 mg, twice daily, until disease progression or intolerable toxicity, switch to the roll-over study or study closure

Intervention Type: DRUG

Other Intervention Names

BMS-354825; Sprycel

Eligibility Criteria

Inclusion Criteria

• Subjects with Philadelphia chromosome positive (PH+) or the fused gene BCR/ABL positive (BCR/ABL+) accelerated phase chronic myeloid leukemia (CML) whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.
• Subjects must have had prior exposure to imatinib. However, imatinib mesylate does not need to be their most recent CML treatment prior to coming on this study.
• 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 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 subjects 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 dasatinib (BMS-354825).
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Bristol-Myers Squibb

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Birmingham, Alabama, United States

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Anaheim, California, United States

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Los Angeles, California, United States

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Stanford, California, United States

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Vallejo, California, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Kansas City, Kansas, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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St Louis, Missouri, United States

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Hackensack, New Jersey, United States

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New York, New York, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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St Leonards, New South Wales, Australia

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South Brisbane, Queensland, Australia

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East Melbourne, Victoria, Australia

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Parkville, Victoria, Australia

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Wien, , Australia

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B-Leuven, , Belgium

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Edegem, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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São Paulo, São Paulo, Brazil

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Campinas, , Brazil

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Toronto, Ontario, Canada

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Aarhus, , Denmark

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Helsinki, , Finland

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Lille, , France

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Lyon, , France

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Nantes, , France

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Paris, , France

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Pessac, , France

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Poitiers, , France

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Strasbourg, , France

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Hamburg, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Ramat Gan, , Israel

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Bologna, , Italy

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Napoli, , Italy

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Orbassano, , Italy

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Roma, , Italy

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Nijmegen, , Netherlands

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Rotterdam, , Netherlands

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Trondheim, , Norway

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Lima, Lima Province, Peru

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Quezon City, , Philippines

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Singapore, , Singapore

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Jeollanam-Do, , South Korea

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Kyunggi-Do, , South Korea

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Seoul, , South Korea

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Gothenburg, , Sweden

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Lund, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Basel, , Switzerland

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Glasgow, Central, United Kingdom

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London, Greater London, United Kingdom

Countries

United States; Argentina; Australia; Belgium; Brazil; Canada; Denmark; Finland; France; Germany; Israel; Italy; Netherlands; Norway; Peru; Philippines; Singapore; South Korea; Sweden; Switzerland; Taiwan; Thailand; United Kingdom

References

Guilhot F, Apperley J, Kim DW, Bullorsky EO, Baccarani M, Roboz GJ, Amadori S, de Souza CA, Lipton JH, Hochhaus A, Heim D, Larson RA, Branford S, Muller MC, Agarwal P, Gollerkeri A, Talpaz M. Dasatinib induces significant hematologic and cytogenetic responses in patients with imatinib-resistant or -intolerant chronic myeloid leukemia in accelerated phase. Blood. 2007 May 15;109(10):4143-50. doi: 10.1182/blood-2006-09-046839. Epub 2007 Jan 30.

Reference Type: BACKGROUND

PMID: 17264298 (View on PubMed)

Apperley JF, Cortes JE, Kim DW, Roy L, Roboz GJ, Rosti G, Bullorsky EO, Abruzzese E, Hochhaus A, Heim D, de Souza CA, Larson RA, Lipton JH, Khoury HJ, Kim HJ, Sillaber C, Hughes TP, Erben P, Van Tornout J, Stone RM. Dasatinib in the treatment of chronic myeloid leukemia in accelerated phase after imatinib failure: the START a trial. J Clin Oncol. 2009 Jul 20;27(21):3472-9. doi: 10.1200/JCO.2007.14.3339. Epub 2009 Jun 1.

Reference Type: BACKGROUND

PMID: 19487385 (View on PubMed)

Other Identifiers

CA180-005

Identifier Type: -

Identifier Source: org_study_id

NCT00108693

Identifier Type: -

Identifier Source: nct_alias