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

Primary Purpose

Leukemia, Myeloid, Chronic

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

AMN107

About this trial

This is an interventional treatment trial for Leukemia, Myeloid, Chronic focused on measuring AMN107, CML, Bcr Abl, cytogenetic response, Chronic Myelogenous Leukemia (CML), imatinib mesylate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AMN107

Arm Description

Outcomes

Primary Outcome Measures

Cytogenetic response within 12 months

Secondary Outcome Measures

To determine the rate of hematologic response at 12 months

To determine the rate of molecular response at 12 months

To evaluate the time to cytogenetic and molecular response

Full Information

NCT ID

NCT00264160

First Posted

December 9, 2005

Last Updated

March 2, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00264160

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

November 2008 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myeloid, Chronic

Keywords

AMN107, CML, Bcr Abl, cytogenetic response, Chronic Myelogenous Leukemia (CML), imatinib mesylate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMN107

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AMN107

Primary Outcome Measure Information:

Title

Cytogenetic response within 12 months

Time Frame

Every 6 months for 12 months

Secondary Outcome Measure Information:

Title

To determine the rate of hematologic response at 12 months

Time Frame

Every Visit for 12 months

Title

To determine the rate of molecular response at 12 months

Time Frame

Every 3 months for 12 months

Title

To evaluate the time to cytogenetic and molecular response

Time Frame

At 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Haifa

Country

Israel

Facility Name

Novartis Investigative Site

City

Jerusalem

Country

Israel

Facility Name

Novartis Investigative Site

City

Petach Tikva

Country

Israel

Facility Name

Novartis Investigative Site

City

Tel Hashomer

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

17715389

Citation

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.

Results Reference

result

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

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