Chronic Myelogenous Leukemia (CML) - Follow on: Study of BMS-354825 in Subjects With CML
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- user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Subjects with Philadelphia chromosome positive (Ph+) (or BCR/ABL+) chronic phase chronic myeloid leukemia whose disease has primary or acquired hematologic resistance to imatinib mesylate or who are intolerant of imatinib mesylate.</li>\n<li>Men and women, 18 years or older</li>\n<li>Adequate hepatic function</li>\n<li>Adequate renal function</li>\n<li>Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Women who are pregnant or breastfeeding</li>\n<li>Subjects who are eligible and willing to undergo transplantation during the screening period</li>\n<li>A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy</li>\n<li>Uncontrolled or significant cardiovascular disease</li>\n<li>Medications that increase bleeding risk</li>\n<li>Medications that change heart rhythms</li>\n<li>Dementia or altered mental status that would prohibit the understanding or rendering of informed consent</li>\n<li>History of significant bleeding disorder unrelated to CML</li>\n<li>Concurrent incurable malignancy other than CML</li>\n<li>Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy</li>\n<li>Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study</li>\n</ul>\n</p>', created = 1283575468, expire = 1283661868, headers = '', serialized = 0 WHERE cid = '1:35957d00dc3ac37c4dac7ce8f5b0bd19' in /persistent/html/includes/cache.inc on line 109.
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Trial phase:
Phase III
Recruitment status:
Active, not recruiting This is a phase III study of BMS-354825 in subjects with chronic phase Philadelphia chromosome or BCR-ABL positive chronic myelogenous leukemia, who are resistant or intolerant to imatinib mesylate (Gleevec).
Conditions
Asthma
Brain and Central Nervous System Tumors
Breast Cancer
Cancer
Cardiovascular Diseases
Colorectal Cancer
Depression
Healthy
Heart Diseases
HIV Infections
Hypertension
Leukemia
Lung Cancer
Lymphoma
Myelodysplastic Syndromes
Obesity
Ovarian Cancer
Prostate Cancer
Schizophrenia
Unspecified Adult Solid Tumor, Protocol Specific
Clinical trial sponsors
AstraZeneca
Bristol-Myers Squibb
Department of Veterans Affairs
Eli Lilly and Company
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
GlaxoSmithKline
Hoffmann-La Roche
M.D. Anderson Cancer Center
Memorial Sloan-Kettering Cancer Center
Merck
National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Drug Abuse (NIDA)
Novartis
Pfizer
Sanofi-Aventis
User login
Study design
Active Control
Cohort
Crossover Assignment
Dose Comparison
Double-Blind
Double Blind (Subject, Investigator)
Efficacy Study
Non-Randomized
Open Label
Other
Parallel Assignment
Placebo Control
Prevention
Prospective
Randomized
Safety/Efficacy Study
Safety Study
Single Group Assignment
Treatment
Uncontrolled
