Status:
APPROVED_FOR_MARKETING
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Myeloid Leukemia
Eligibility:
All Genders
18-60 years
Brief Summary
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ...
Eligibility Criteria
Inclusion
- Having participated in Novartis study CAMN107A2109, and
- Written signed and dated informed consent prior to any study procedures being performed.
Exclusion
- Impaired cardiac function,
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
- Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
- patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
- Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
- Patients unwilling or unable to comply with the protocol.
- Other protocol -defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2008
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00905593
Start Date
September 1 2008
Last Update
July 18 2012
Active Locations (2)
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1
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
2
Novartis Investigative Site
Mexico City, Mexico