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Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00264160
First received: December 9, 2005
Last updated: March 2, 2017
Last verified: August 2012

December 9, 2005
March 2, 2017
May 2006
November 2008   (Final data collection date for primary outcome measure)
Cytogenetic response within 12 months [ Time Frame: Every 6 months for 12 months ]
Not Provided
Complete list of historical versions of study NCT00264160 on ClinicalTrials.gov Archive Site
  • To determine the rate of hematologic response at 12 months [ Time Frame: Every Visit for 12 months ]
  • To determine the rate of molecular response at 12 months [ Time Frame: Every 3 months for 12 months ]
  • To evaluate the time to cytogenetic and molecular response [ Time Frame: At 12 months ]
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Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy
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.
Not Provided
Interventional
Phase 2
Phase 3
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Leukemia, Myeloid, Chronic
Drug: AMN107
Experimental: AMN107
Intervention: Drug: AMN107
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. Epub 2007 Aug 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2009
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase
  • Males or females ≥ 18 years of age

Exclusion Criteria:

  • Impaired cardiac function
  • Acute or chronic liver or renal disease
  • Use of therapeutic coumadin
  • Central nervous system (CNS) infiltration

Additional protocol-defined inclusion/exclusion criteria may apply.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00264160
CAMN107AIL01
Not Provided
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Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP