A phase 2 multicenter clinical study evaluating the safety and efficacy of Nilotinib in patients with Imatinib- resistant/intolerant CML in chronic phase
Phase 2
- Conditions
- Chronic myelogenous leukemia
- Registration Number
- JPRN-UMIN000001927
- Lead Sponsor
- Tokyo STI Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method