Spots Global Cancer Trial Database for Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
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Trial Identification
Brief Title: Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
Official Title: A Phase I/II Study of BMS-354825 in Subjects With Imatinib Resistant or Intolerant Philadelphia Chromosome Positive Chronic Myelogenous Leukemia and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Who Are Resistant or Intolerant to Treatment
Study ID: NCT00337454
Conditions
Study Description
Brief Summary: This study is composed of Phase I and Phase II part. Phase I part: The objective is to evaluate the safety of BMS-354825 in subject with chronic phase Chronic Myelogenous Leukemia (CML). Dosage of BMS-354825 will be 50 mg BID, 70 mg BID or 90 mg BID. Phase II part: The objective is to evaluate the efficacy of BMS-354825. dosage will be decided according to the results of Phase I part. Treatment period will be 6 months for subjects with chronic phase CML, and 3 months for subjects with accelerated phase or blast phase CML and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ALL)
Detailed Description:
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Local Institution, Nagoya-Shi, Aichi, Japan
Local Institution, Nagoya, Aichi, Japan
Local Institution, Nagoya, Aichi, Japan
Local Institution, Maebashi, Gunma, Japan
Local Institution, Nishinomiya-Shi, Hyogo, Japan
Local Institution, Kagoshima-Shi, Kagoshima, Japan
Local Institution, Isehara-Shi, Kanagawa, Japan
Local Institution, Sendai, Miyagi, Japan
Local Institution, Nagasaki City, Nagasaki, Japan
Local Institution, Okayama-Shi, Okayama, Japan
Local Institution, Moriguchi, Osaka, Japan
Local Institution, Iruma-Gun, Saitama, Japan
Local Institution, Hamamatsu-Shi, Shizuoka, Japan
Local Institution, Bunkyo-Ku, Tokyo, Japan
Local Institution, Chuo-Ku, Tokyo, Japan
Local Institution, Shinjuku-Ku, Tokyo, Japan
Local Institution, Shinjuku-Ku, Tokyo, Japan
Local Institution, Kanagawa, , Japan
Local Institution, Kyoto, , Japan
Local Institution, Tochigi, , Japan
Local Institution, Tokyo, , Japan
Contact Details
Name: Bristol-Myers Squibb
Affiliation: Bristol-Myers Squibb
Role: STUDY_DIRECTOR
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