NCT00905593

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

2.6 years

First QC Date

May 18, 2009

Last Update Submit

July 17, 2012

Conditions

Chronic Myeloid Leukemia

Keywords

chronic myeloid leukemia,blast crisis,accelerated phase,nilotinib,imatinib,resistant,intolerant,chronic phase

Interventions

NilotinibDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Guadalajara, Jalisco, Mexico

Location

Novartis Investigative Site

Mexico City, Mexico

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveBlast Crisis

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCell Transformation, NeoplasticCarcinogenesisNeoplastic Processes

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2009

First Posted

May 20, 2009

Study Start

September 1, 2008

Primary Completion

April 1, 2011

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

ME(2)