JPRN-UMIN000001927
Unknown
Phase 2
A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase - Multicenter clinical study of Nilotinib in CML patients with Imatinib resistance or intolerance(TSSG nilotinib-study)
Tokyo STI Study Group0 sites50 target enrollmentMay 1, 2009
ConditionsChronic myelogenous leukemia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic myelogenous leukemia
- Sponsor
- Tokyo STI Study Group
- Enrollment
- 50
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Patients who have received treatment with tyrosine kinase inhibitors(except for imatinib) prior to study entry. 2\) Patients who are receiving treatment with other investigational agents. 3\) Patients who exhibit the T315I BCR\-ABL mutation. 4\) Patients who have any cardiac disturbances. 5\) Severe medical conditions. 6\) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug. 7\) Patients who are: (a)pregnant, (b)breast feeding, (c)male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial.
Outcomes
Primary Outcomes
Not specified
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