A Randomized, Multicenter, Open-label Phase II Study of Dasatinib (BMS-354825) Administered Orally at a Dose of 50mg Twice Daily or 100mg Once Daily in Subjects With Chronic Phase Philadelphia Chromosome Positive Chronic Myeloid Leukemia Who Are Resistant or Intolerant to Imatinib

简要总结

主要结局

次要结局

• Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations, and Deaths During Treatment(Throughout study period to last observation. Dosing period=6 months; if beneficial, medication may continue in the extension period (ending in January 2009). Last observation=30 days past last dosing day or the discontinuation day.)
• Complete Hematologic Response (CHR) in Imatinib-Intolerant and Imatinib-Resistant Participants at Week 24(Week 24)
• Time to Major Cytogenetic Response (MCyR)(time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met)
• Pharmacokinetics of Dasatinib (BMS-354825) as Characterized by Population Pharmacokinetics(Six or more peripheral blood samples were collected at any visit after Day 7, pre-dose and 5 - 8 hours after dose administration.)
• Duration of MCyR(from the first day all criteria are met for CCyR or PCyR until the date of progressed disease (PD) or death)
• Time to CHR(time from first dose of Dasatinib (BMS-354825) until the first day CHR criteria are met)
• Duration of CHR(measured from the first day all criteria were first met for CHR (provided subjects achieved a cCHR), until the date PD is first reported or until death)
• Expression of BCR-ABL Gene Mutations of RNA (mRNA)(Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.))
• Progression-Free Survival (PFS)(time from first dose of Dasatinib (BMS-354825) until the first day criteria for CCyR or PCyR, whichever occurs first, are first met)
• Mutational Spectrum of BCR-ABL(Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.))
• Cytogenetic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study(Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.))
• Hematologic Response in Imatinib-Intolerant and Imatinib-Resistant Participants at End of Study(Baseline and at the end of long term extension period (The enrollment period was followed by an extension period until the launch of dasatinib in Japan, January 2009.))