JPRN-UMIN000002007
Completed
Phase 2
A phase 2 multicenter study evaluating the safety and efficacy of Nilotinib in patients with Imatinib-resistant/intolerant Ph+CML in chronic phase - Multicenter study of Nilotinib in CML patients with Imatinib resistance or intolerance (Shimousa Nilotinib Study)
Shimousa Hematology Study Group0 sites40 target enrollmentJune 1, 2009
ConditionsChronic myelogenous leukemia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Chronic myelogenous leukemia
- Sponsor
- Shimousa Hematology Study Group
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1\) Patients who have been treated with tyrosine kinase inhibitors (except for imatinib) prior to study entry. 2\) Patients whose clone exhibit the T315I BCR\-ABL mutation. 3\) Patients who have any cardiac disturbances. 4\) Patients who are: (a) pregnant, (b) breast feeding, (c) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial. 5\) Severe medical conditions. 6\) Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
Outcomes
Primary Outcomes
Not specified
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