These clinical study results are supplied for informational purposes only in the interests of scientific disclosure. They are not intended to substitute for the FDA-approved package insert or other approved labeling. Drug Details Company Name Business Partner Drug Name Generic Name Unique ID Studied Indications or Disease Phase Approved Drug Label Bristol-Myers Squibb SPRYCEL™ dasatinib CA180-Leuk-I Leukemia Phase I http://packageinserts.bms.com/pi/pi_sprycel.pdf Clinical Study Summary 1) CA180-002 ST: A Phase I Dose-Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-354825 in the Treatment of Patients With Chronic, Accelerated or Blast Phase Chronic Myelogenous Leukemia, or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia who have Hematologic Resistance to Imatinib Mesylate (Gleevec Tm). Publication: Talpaz M, Shah NP, Kantarjian H, Donato N, Nicoll J, Paquette R, et al. Dasatinib in imatinib-resistant Philadelphia chromosome-positive leukemias. N Engl J Med. 2006 Jun 15;354(24):2531-41. Abstract: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16775234&query_hl=6&itool=pubmed_docsum Registration: http://www.clinicaltrials.gov/ct/show/NCT00103701 2) CA180-021 ST: Effect of Ketoconazole on the Pharmacokinetics of BMS-354825 in Patients with Advanced Solid Tumors. Registration: http://www.clinicaltrials.gov/ct2/show/NCT00162214 3) CA180-039 ST: Long-Term Safety and Efficacy of Dasatinib (BMS-354825) in Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia in Subjects who Experienced Benefit on Protocol CA180-002. Registration: http://www.clinicaltrials.gov/ct2/results?term=NCT00978731 4) CA180-249 ST: The Effect of Omeprazole on the Pharmacokinetics of Dasatinib (BMS-354825) in Healthy Subjects. Registration: http://clinicaltrials.gov/ct2/show/NCT00655746 In addition to the Drug Label information contained on this website, data related to SPRYCEL™ (dasatinib) can be found at the Food and Drug Administration's website. Navigate to the Oncologic Drugs Advisory Committee section for June 2, 2006 using this http://www.fda.gov/ohrms/dockets/ac/cder06.html#OncologicDrugs link. Select the link entitled "June 2, 2006 Briefing Information" to view SPRYCEL™ (dasatinib) data that were provided for the Advisory Committee meeting. For FDA Safety Alerts and Recalls refer to the following link: www.fda.gov/MEDWATCH/safety.htm Bristol-Myers Squibb Company does not intend for the contents of this website to be construed as medical advice. You should rely only on your healthcare professional for advice on your specific situation. Company Study CA180-002 ST CA180-021 ST CA180-249 ST CA180-039 ST Back to Search Results