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NCT00264160 Clinical Trial

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

Leukemia, Myeloid, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00264160
Other study ID # CAMN107AIL01
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received December 9, 2005
Last updated March 2, 2017
Start date May 2006
Est. completion date August 2009

Study information
Verified date August 2012
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date August 2009
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• AMN107

Locations
Country Name City State
Israel Novartis Investigative Site Haifa
Israel Novartis Investigative Site Jerusalem
Israel Novartis Investigative Site Petach Tikva
Israel Novartis Investigative Site Tel Hashomer

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Israel, 

References & 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 selecti — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cytogenetic response within 12 months Every 6 months for 12 months
Secondary To determine the rate of hematologic response at 12 months Every Visit for 12 months
Secondary To determine the rate of molecular response at 12 months Every 3 months for 12 months
Secondary To evaluate the time to cytogenetic and molecular response At 12 months
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