Active, Not Recruiting
Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects - CA180-160
Updated: 29 November, 2017 | ClinicalTrials.gov
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Trial Details
Phase
Gender(s)
Age Range
Active, Not Recruiting
Treatment Options
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Signed Written Informed Consent - Men and women, ages 18 years of age or older - Subjects with Chronic Phase (CP) or Advanced Disease (AD) chronic myeloid leukemia (CML)/Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Subjects resistant/intolerant to imatinib - Subjects presenting: 1. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2 2. Adequate hepatic function 3. Adequate renal function 4. Sodium, Potassium, Magnesium, Phosphorus, Calcium higher or equal than the lower limit of normal range Exclusion Criteria: - Women of child bearing potential who are not using adequate birth control - Women who are pregnant or breastfeeding - Subjects eligible for stem cell transplantation - Serious uncontrolled medical disorder or active infection - Uncontrolled or significant cardiovascular disease - Concurrent incurable malignancy other than CML - Subjects who received imatinib, interferon, cytarabine within 7 days or other antineoplastic agents other than hydroxyurea within 14 days before dasatinib, Dasatinib in the past - History of significant bleeding unrelated to CML
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