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: August 6, 2012
Last verified: August 2012

December 9, 2005
August 6, 2012
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • To determine the rate of molecular response at 12 months [ Time Frame: Every 3 months for 12 months ] [ Designated as safety issue: Yes ]
  • To evaluate the time to cytogenetic and molecular response [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Myeloid, Chronic
Drug: AMN107
Experimental: AMN107
Intervention: Drug: AMN107
Not Provided

*   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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00264160
CAMN107AIL01
Not Provided
Novartis ( 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