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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Chronic Myeloid Leukemia; Philadelphia-Positive Myeloid Leukemia

Treatments: Drug: Dasatinib; Drug: Imatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00103844

CA180-017

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1

Experimental group

Description:

Active Comparator

Treatment:

Drug: Dasatinib

2

Experimental group

Description:

Active Comparator

Treatment:

Drug: Imatinib

Sponsor of this trial

Lead Sponsor

Bristol-Myers Squibb (BMS)