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

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.

Official Title

A Randomized Multi-Center Open Label Study of BMS-354825 vs. Imatinib Mesylate (Gleevec) 800 mg/d in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to Imatinib at a Dose at 400 – 600 mg/d

Conditions

Chronic Myeloid Leukemia

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• To estimate the major cytogenetic response (MCyR) rates of BMS-354825 and imatinib at 800 mg daily at 12 weeks

Secondary Outcome Measures:

• Safety and Efficacy

Study Start

February 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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.

Total Enrolment

150

Contact Details

• St. Leonards, New South Wales, Australia
• Camperdown, New South Wales, Australia
• South Brisbane, Queensland, Australia
• Adelaide, South Australia, Australia
• Perth, Western Australia, Australia

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