Dasatinib (BMS-354835) Versus Imatinib Mesylate in Subjects With Chronic Myeloid Leukemia

NCT ID: NCT00103844

Last Updated: 2010-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-03-31

Brief Summary

The primary purpose of this study is to estimate the major cytogenetic response rates of BMS-354825 and imatinib (800 mg/d) in subjects with chronic phase, Philadelphia chromosome positive, chronic myeloid leukemia (PH+ CML) with disease resistant to imatinib at a dose of 400-600 mg/d.

Conditions

Chronic Myeloid Leukemia; Philadelphia-Positive Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Active Comparator

Group Type: EXPERIMENTAL

Dasatinib

Intervention Type: DRUG

Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks

2

Active Comparator

Group Type: EXPERIMENTAL

Imatinib

Intervention Type: DRUG

Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks

Interventions

Dasatinib

Tablets, oral, 20 mg and 50mg, twice daily, up to 96 weeks

Intervention Type: DRUG

Imatinib

Tablets, Oral, 400mg and 100mg, twice daily, up to 96 weeks

Intervention Type: DRUG

Other Intervention Names

Sprycel; BMS-354825

Eligibility Criteria

Inclusion Criteria

• Men and women, 18 years of age or older.
• Subjects with Chronic Phase Ph+ CML.
• Subjects have not been treated with imatinib at a dose >600 mg/day.
• Subjects developed resistance to disease while receiving an imatinib dose 400-600 mg/day.
• Able to tolerate imatinib at the highest dose the subject had received in the past.
• Demonstrate adequate renal and hepatic function.
• Women of childbearing potential must have a negative serum or urine pregnancy test, must be using an adequate method of contraception.

Exclusion Criteria

• Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period for a least 1 month before and at least 3 months after the completion of the study.
• Women using a prohibited contraceptive method.
• Women 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.
• Prior treatment with imatinib at a dose >600 mg/day.
• Subjects who have previously identified specific BCR-ABL mutations.
• Previous diagnosis of accelerated phase or blast crisis CML.
• Intolerance to imatinib at any dose.
• Subjects who are eligible and willing to undergo transplantation during the screening period.
• Serious uncontrolled medical disorder or active infection.
• Uncontrolled or significant cardiovascular disease.
• Uncontrolled hypertension.
• Dementia or altered mental status.
• Evidence of organ dysfunction.
• Use of imatinib within 7 days.
• Use of interferon or cytarabine within 14 days.
• Use of a targeted small molecule anticancer agent within 14 days.
• Subjects taking certain medications that are accepted to have a risk of causing Torsades de Pointes.
• Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
• Prior therapy with BMS-354825.

• 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

Local Institution

Birmingham, Alabama, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Fullerton, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Monterey Park, California, United States

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San Diego, California, United States

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Santa Barbara, California, United States

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Santa Maria, California, United States

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Stanford, California, United States

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Vallejo, California, United States

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Aurora, Colorado, United States

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Hartford, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Athens, Georgia, United States

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Atlanta, Georgia, United States

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Lawrenceville, Georgia, United States

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Tucker, Georgia, United States

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Chicago, Illinois, United States

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Peoria, Illinois, United States

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Indianapolis, Indiana, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Boston, Massachusetts, United States

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Minneapolis, Minnesota, United States

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Rochester, Minnesota, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Hackensack, New Jersey, United States

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Morristown, New Jersey, United States

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New Brunswick, New Jersey, United States

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Cary, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Greenville, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Tyler, Texas, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Spokane, Washington, United States

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Vancouver, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Córdoba, Córdoba Province, Argentina

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Camperdown, New South Wales, Australia

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St Leonards, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Adelaide, South Australia, Australia

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Perth, Western Australia, Australia

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Wein, , Austria

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B-Leuven, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Charleroi, , Belgium

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Edegem, , Belgium

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Yvoir, , Belgium

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Curitiba, Paraná, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, , China

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Shanghai, , China

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Aarhus, , Denmark

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Tallinn, , Estonia

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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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Dresden, , Germany

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Groenkloof, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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Budapest, , Hungary

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Dublin, , Ireland

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Ramat Gan, , Israel

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Bari, , Italy

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Bologna, , Italy

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Milan, , Italy

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Napoli, , Italy

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Orbassano, , Italy

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Roma, , Italy

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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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Katowice, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Warsaw, , Poland

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San Juan, , Puerto Rico

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Moscow, , Russia

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Saint Petersburg, , Russia

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Singapore, , Singapore

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Bloemfontein, Free State, South Africa

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Parktown, Gauteng, South Africa

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Soweto, Gauteng, South Africa

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Kyunggi-Do, , South Korea

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Barcelona, , Spain

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Madrid, , Spain

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Gothenburg, , Sweden

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Lund, , Sweden

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Stockholm, , Sweden

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Umeå, , Sweden

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Uppsala, , Sweden

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Basel, , Switzerland

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Bellinzona, , Switzerland

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Glasglow, Central, United Kingdom

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London, Greater London, United Kingdom

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Newcastle, Tyne and Wear, United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Canada; China; Denmark; Estonia; Finland; France; Germany; Hungary; Ireland; Israel; Italy; Norway; Peru; Philippines; Poland; Puerto Rico; Russia; Singapore; South Africa; South Korea; Spain; Sweden; Switzerland; Taiwan; Thailand; United Kingdom

References

Kantarjian H, Pasquini R, Levy V, Jootar S, Holowiecki J, Hamerschlak N, Hughes T, Bleickardt E, Dejardin D, Cortes J, Shah NP. Dasatinib or high-dose imatinib for chronic-phase chronic myeloid leukemia resistant to imatinib at a dose of 400 to 600 milligrams daily: two-year follow-up of a randomized phase 2 study (START-R). Cancer. 2009 Sep 15;115(18):4136-47. doi: 10.1002/cncr.24504.

Reference Type: BACKGROUND

PMID: 19536906 (View on PubMed)

Muller MC, Cortes JE, Kim DW, Druker BJ, Erben P, Pasquini R, Branford S, Hughes TP, Radich JP, Ploughman L, Mukhopadhyay J, Hochhaus A. Dasatinib treatment of chronic-phase chronic myeloid leukemia: analysis of responses according to preexisting BCR-ABL mutations. Blood. 2009 Dec 3;114(24):4944-53. doi: 10.1182/blood-2009-04-214221. Epub 2009 Sep 24.

Reference Type: BACKGROUND

PMID: 19779040 (View on PubMed)

Other Identifiers

CA180-017

Identifier Type: -

Identifier Source: org_study_id