A Phase II Study to Determine the Activity of BMS-354825 in Subjects With Chronic Phase Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Disease That is Resistant to High Dose Imatinib Mesylate (Gleevec) or Who Are Intolerant of Imatinib

简要总结

主要结局

次要结局

• Number of Imatinib-intolerant Participants With MCyR(Baseline to 2 years)
• Percentage of Participants Who Achieved MCyR and Did Not Progress at 12 and 24 Months(12 and 24 Months)
• Median Time From First Dosing Date to Date of MCyR(Baseline (within 4 weeks of Day 1) and every 12 weeks)
• Number of Participants With Complete Hematologic Response (CHR)(Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study)
• Percentage of Participants Who Acheived CHR and Did Not Progress at 12 Months and 24 Months(12 and 24 months)
• Median Time From First Dosing Until CHR(Baseline (within 72 hours of start of therapy), weekly until Week 12, every 3 months until off-study)
• Number of Participants With Major Molecular Response (MMR)(Baseline to 2 years)
• Minimal Clinically Significant Change From Baseline in Functional Assessment of Cancer Therapy-General (FACT-G) Questionnaire Scores(Baseline, Day 29, every 4 weeks for the first 24 weeks, then every 12 weeks for the remainder of treatment, after end of treatment. Treatment continued until disease progression or development of toxicity or until other protocol-defined criteria.)
• Number of Imitanib-intolerant Participants With Drug-related Adverse Events (AEs), Death Within 30 Days of Last Dose, Death, and AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Grade 3-4 Thrombocytopenia, Grade 4-4 Neutropenia, and Any AE(Continuously, from baseline through 2 years)
• Number of Imitanib-resistant Participants With Drug-related AEs, Death Within 30 Days of Last Dose, Death, AEs Leading to Discontinuation, SAEs, Grade 3-4 Thrombocytopenia, Grade 3-4 Neutropenia, and Any AE(Continuously, from baseline through 2 years)
• Blood Sample Collection for Pharmacokinetic (PK) Analysis of Dasatinib(Day 8 of study; pretreatment through sample between 30 minutes and 3 hours following treatment, a sample between 5 hours and 8 hours following treatment and a sample at 12 hours, prior to the next dose.)