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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00905593
Expanded Access Status : Approved for marketing
First Posted : May 20, 2009
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Chronic Myeloid Leukemia Drug: Nilotinib

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 : September 2008
Estimated Primary Completion Date : April 2011

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Other protocol -defined inclusion/exclusion criteria may apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00905593

Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Mexico City, Mexico
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Pharmaceuticals Identifier: NCT00905593     History of Changes
Other Study ID Numbers: CAMN107AMX01
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
chronic myeloid leukemia,
blast crisis,
accelerated phase,
chronic phase

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Neoplastic Processes
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action