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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00339144 |
The primary objective of this study is to determine the maximum tolerated dose (MTD) or the maximum administered dose(MAD) of Dasatinib (BMS-354825) in patients in Japan.
Condition | Intervention | Phase |
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Tumors |
Drug: dasatinib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Study of BMS-354825 in Patients With Solid Tumors |
Enrollment: | 0 |
Study Start Date: | January 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A1: Experimental |
Drug: dasatinib
tablets, Oral, 100 mg, once daily for 4 weeks
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A2: Experimental |
Drug: dasatinib
tablets, Oral, 150 mg, once daily, 4 weeks
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A3: Experimental |
Drug: dasatinib
tablets, Oral, 200 mg, once daily for 4 weeks
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A4: Experimental |
Drug: dasatinib
tablets, Oral, 250 mg, once daily for 4 weeks
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Osaka | |
Local Institution | |
Osakasayama City, Osaka, Japan, 589-0014 | |
Japan, Tokyo | |
Local Institution | |
Koto-Ku, Tokyo, Japan, 135-0063 |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CA180-058 |
Study First Received: | June 19, 2006 |
Last Updated: | December 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00339144 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists |
Dasatinib |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |