Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
1 other identifier
interventional
36
1 country
4
Brief Summary
This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2006
Typical duration for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2005
CompletedFirst Posted
Study publicly available on registry
December 12, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedMarch 6, 2017
August 1, 2012
2.5 years
December 9, 2005
March 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cytogenetic response within 12 months
Every 6 months for 12 months
Secondary Outcomes (3)
To determine the rate of hematologic response at 12 months
Every Visit for 12 months
To determine the rate of molecular response at 12 months
Every 3 months for 12 months
To evaluate the time to cytogenetic and molecular response
At 12 months
Study Arms (1)
AMN107
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase
- Males or females ≥ 18 years of age
You may not qualify if:
- Impaired cardiac function
- Acute or chronic liver or renal disease
- Use of therapeutic coumadin
- Central nervous system (CNS) infiltration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Novartis Investigative Site
Haifa, Israel
Novartis Investigative Site
Jerusalem, Israel
Novartis Investigative Site
Petah Tikva, Israel
Novartis Investigative Site
Tel Litwinsky, Israel
Related Publications (1)
Kantarjian HM, Giles F, Gattermann N, Bhalla K, Alimena G, Palandri F, Ossenkoppele GJ, Nicolini FE, O'Brien SG, Litzow M, Bhatia R, Cervantes F, Haque A, Shou Y, Resta DJ, Weitzman A, Hochhaus A, le Coutre P. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood. 2007 Nov 15;110(10):3540-6. doi: 10.1182/blood-2007-03-080689. Epub 2007 Aug 22.
PMID: 17715389RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2005
First Posted
December 12, 2005
Study Start
May 1, 2006
Primary Completion
November 1, 2008
Study Completion
August 1, 2009
Last Updated
March 6, 2017
Record last verified: 2012-08