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

March 2, 2017 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Novartis Investigative Site
      • Jerusalem, Israel
        • Novartis Investigative Site
      • Petach Tikva, Israel
        • Novartis Investigative Site
      • Tel Hashomer, Israel
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMN107
Drug: AMN107

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cytogenetic response within 12 months
Time Frame: Every 6 months for 12 months
Every 6 months for 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the rate of hematologic response at 12 months
Time Frame: Every Visit for 12 months
Every Visit for 12 months
To determine the rate of molecular response at 12 months
Time Frame: Every 3 months for 12 months
Every 3 months for 12 months
To evaluate the time to cytogenetic and molecular response
Time Frame: At 12 months
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

December 9, 2005

First Submitted That Met QC Criteria

December 9, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Actual)

March 6, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMN107AIL01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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