Status:
COMPLETED
Study of BMS-354825 in Subjects With CML Who Are Resistant to or Intolerant of Imatinib or Ph+All in Japan
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Myelogenous Leukemia
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- Philadelphia chromosome positive or bcr-abl gene positive
- Chronic Myelogenous Leukemia (CML)
- Subjects must have primary or acquired resistance to imatinib mesylate or have intolerance of imatinib mesylate
- Philadelphia Chromosome Positive Acute Lymphoblastic leukemia (Ph+ALL)
- Subjects must have primary or acquired resistance to chemotherapy or have intolerance of chemotherapy
- Performance status (general conditions) specified by the Eastern Cooperative Oncology Group: 0-2
- Men and women, ages 20 - 75
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 3 months after the study in such a manner that the risk of pregnancy is minimized
Exclusion
- Subjects who are eligible and willing to undergo transplantation at pre-study
- Women who are pregnant or breastfeeding
- Uncontrolled or significant cardiovascular disease
- History of significant bleeding disorder unrelated to CML or ALL
- Adequate hepatic function
- Adequate renal function
- Medication that increase bleeding risk
- Medication that change heart rhythms
- Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00337454
Start Date
July 1 2005
End Date
March 1 2007
Last Update
April 14 2011
Active Locations (21)
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1
Local Institution
Nagoya, Aichi-ken, Japan, 464-8681
2
Local Institution
Nagoya, Aichi-ken, Japan, 466-8550
3
Local Institution
Nagoya, Aichi-ken, Japan, 467-8602
4
Local Institution
Maebashi, Gunma, Japan, 371-0821