Dasatinib in Imatinib Resistant/Intolerant Chinese CML (Chronic and Advanced Phase) Subjects
NCT ID: NCT00529763
Last Updated: 2023-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2007-11-17
2022-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Dasatinib
Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study
Interventions
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Dasatinib
Tablets, Oral, 70 mg BID (AD CML) or 100 mg QD (Chronic CML), once or twice daily dependent on disease stage, until subjects meet discontinuation (DC) criteria for study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Beijing, Beijing Municipality, China
Local Institution - 0004
Fuzhou, Fujian, China
Local Institution
Fuzhou, Fujian, China
Local Institution
Guangzhou, Guangdong, China
Local Institution
Nanjing, Jiangsu, China
Local Institution - 0008
Suzhou, Jiangsu, China
Local Institution
Suzhou, Jiangsu, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Shanghai, Shanghai Municipality, China
Local Institution
Chengdou, Sichuan, China
Local Institution
Chengdu, Sichuan, China
Local Institution
Tianjin, Tianjin Municipality, China
Local Institution - 0009
Hangzhou, Zhejiang, China
Local Institution
Hangzhou, Zhejiang, China
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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CA180-160
Identifier Type: -
Identifier Source: org_study_id
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