ENACT: Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Approved for marketing

CT.gov ID

NCT00905593

Collaborator

(none)

Locations

Study Details

Study Description

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 ongoing patients participating on [CAMN107A2109] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloid Leukemia	Drug: Nilotinib

Study Design

Study Type:

Expanded Access

Official Title:

An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Apr 1, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Having participated in Novartis study CAMN107A2109, and
Written signed and dated informed consent prior to any study procedures being performed.

Exclusion Criteria:

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.