Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia

August 25, 2011 updated by: Novartis Pharmaceuticals

An Open-label, Multicenter, Expanded Access Study of Oral AMN107 in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase.

This study will further evaluate if AMN107 is safe in adults with chronic myeloid leukemia who are resistant or intolerant to imatinib and to provide patients access to this new drug until the drug becomes commercially available.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

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

  • Australia
      • Saint Leonards, Australia
        • Novartis Investigative Site
  • Austria
      • Graz, Austria
        • Novartis Investigative Site
      • Innsbruck, Austria
        • Novartis Investigative Site
      • Linz, Austria
        • Novartis Investigative Site
      • Wels, Austria
        • Novartis Investigative Site
      • Wien, Austria
        • Novartis Investigative Site
  • Belgium
      • Aalst, Belgium
        • Novartis Investigative Site
      • Antwerpen, Belgium
        • Novartis Investigative Site
      • Arlon, Belgium
        • Novartis Investigative Site
      • Brugge, Belgium
        • Novartis Investigative Site
      • Brussels, Belgium
        • Novartis Investigative Site
      • Bruxelles, Belgium
        • Novartis Investigative Site
      • Edegem, Belgium
        • Novartis Investigative Site
      • Gent, Belgium
        • Novartis Investigative Site
      • Hasselt, Belgium
        • Novartis Investigative Site
      • La Louviere, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
      • Liege, Belgium
        • Novartis Investigative Site
      • Roeselare, Belgium
        • Novartis Investigative Site
      • Verviers, Belgium
        • Novartis Investigative Site
      • Yvoir, Belgium
        • Novartis Investigative Site
  • Brazil
      • Belo Horizonte, Brazil
        • Novartis Investigative Site
      • Brasilia-DF, Brazil
        • Novartis Investigative Site
      • Campinas, Brazil
        • Novartis Investigative Site
      • Curitaba, Brazil
        • Novartis Investigative Site
      • Curitiba, Brazil
        • Novartis Investigative Site
      • Porto Alegre-RS, Brazil
        • Novartis Investigative Site
      • Ribeirao Preto, Brazil
        • Novartis Investigative Site
      • Rio de Janeiro, Brazil
        • Novartis Investigative Site
      • Sao Paulo, Brazil
        • Novartis Investigative Site
  • Canada
      • Edmonton, Canada
        • Novartis Investigative Site
      • Halifax, Canada
        • Novartis Investigative Site
      • Hamilton, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • Ottawa, Canada
        • Novartis Investigative Site
      • Toronto, Canada
        • Novartis Investigative Site
      • Vancouver, Canada
        • Novartis Investigative Site
  • China
      • Beijing, China
        • Novartis Investigative Site
      • Guangzhou, China
        • Novartis Investigative Site
      • Shanghai, China
        • Novartis Investigative Site
      • Tianjing, China
        • Novartis Investigative Site
  • Czech Republic
      • Brno, Czech Republic
        • Novartis Investigative Site
      • Hradec Kralove, Czech Republic
        • Novartis Investigative Site
      • Olomouc, Czech Republic
        • Novartis Investigative Site
      • Plzen-Lochotin, Czech Republic
        • Novartis Investigative Site
      • Praha 2, Czech Republic
        • Novartis Investigative Site
  • Denmark
      • Copenhagen, Denmark
        • Novartis Investigative Site
      • Vejle, Denmark
        • Novartis Investigative Site
  • France
      • Angers, France
        • Novartis Investigative Site
      • Bordeaux, France
        • Novartis Investigative Site
      • Caen, France
        • Novartis Investigative Site
      • Clermont-Ferrand, France
        • Novartis Investigative Site
      • Creteil, France
        • Novartis Investigative Site
      • Dijon, France
        • Novartis Investigative Site
      • Grenoble, France
        • Novartis Investigative Site
      • Le Chesnay, France
        • Novartis Investigative Site
      • Lille, France
        • Novartis Investigative Site
      • Limoges, France
        • Novartis Investigative Site
      • Lyon, France
        • Novartis Investigative Site
      • Marseille, France
        • Novartis Investigative Site
      • Nantes, France
        • Novartis Investigative Site
      • Nice, France
        • Novartis Investigative Site
      • Paris, France
        • Novartis Investigative Site
      • Poitiers, France
        • Novartis Investigative Site
      • Reims, France
        • Novartis Investigative Site
      • Rennes, France
        • Novartis Investigative Site
      • Rouen, France
        • Novartis Investigative Site
      • Strasbourg, France
        • Novartis Investigative Site
      • Toulouse, France
        • Novartis Investigative Site
      • Vandoeuvre, France
        • Novartis Investigative Site
      • Vandoeuvre les Nancy, France
        • Novartis Investigative Site
  • Germany
      • Aschaffenburg, Germany
        • Novartis Investigative Site
      • Augsburg, Germany
        • Novartis Investigative Site
      • Berlin, Germany
        • Novartis Investigative Site
      • Braunschweig, Germany
        • Novartis Investigative Site
      • Bremen, Germany
        • Novartis Investigative Site
      • Bremerhaven, Germany
        • Novartis Investigative Site
      • Chemnitz, Germany
        • Novartis Investigative Site
      • Dresden, Germany
        • Novartis Investigative Site
      • Essen, Germany
        • Novartis Investigative Site
      • Frankfurt, Germany
        • Novartis Investigative Site
      • Freiburg, Germany
        • Novartis Investigative Site
      • Greifswald, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Hannover, Germany
        • Novartis Investigative Site
      • Heidelberg, Germany
        • Novartis Investigative Site
      • Kiel, Germany
        • Novartis Investigative Site
      • Koln, Germany
        • Novartis Investigative Site
      • Leipzig, Germany
        • Novartis Investigative Site
      • Mainz, Germany
        • Novartis Investigative Site
      • Mannheim, Germany
        • Novartis Investigative Site
      • Marburg, Germany
        • Novartis Investigative Site
      • Munchen, Germany
        • Novartis Investigative Site
      • Oldenburg, Germany
        • Novartis Investigative Site
      • Osnabruck, Germany
        • Novartis Investigative Site
      • Regensburg, Germany
        • Novartis Investigative Site
      • Stuttgart, Germany
        • Novartis Investigative Site
      • Tubingen, Germany
        • Novartis Investigative Site
      • Ulm, Germany
        • Novartis Investigative Site
      • Weiden, Germany
        • Novartis Investigative Site
      • Wiesbaden, Germany
        • Novartis Investigative Site
  • Greece
      • Athens, Greece
        • Novartis Investigative Site
  • Hong Kong
      • Pokfulam, Hong Kong
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
  • Ireland
      • Dublin, Ireland
        • Novartis Investigative Site
  • Italy
      • Ancona, Italy
        • Novartis Investigative Site
      • Bari, Italy
        • Novartis Investigative Site
      • Bologna, Italy
        • Novartis Investigative Site
      • Bolzano, Italy
        • Novartis Investigative Site
      • Brescia, Italy
        • Novartis Investigative Site
      • Cagliari, Italy
        • Novartis Investigative Site
      • Campobasso, Italy
        • Novartis Investigative Site
      • Catania, Italy
        • Novartis Investigative Site
      • Catanzaro, Italy
        • Novartis Investigative Site
      • Ferrara, Italy
        • Novartis Investigative Site
      • Firenze, Italy
        • Novartis Investigative Site
      • Genova, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Monza, Italy
        • Novartis Investigative Site
      • Napoli, Italy
        • Novartis Investigative Site
      • Novara, Italy
        • Novartis Investigative Site
      • Nuoro, Italy
        • Novartis Investigative Site
      • Orbassano, Italy
        • Novartis Investigative Site
      • Padova, Italy
        • Novartis Investigative Site
      • Palermo, Italy
        • Novartis Investigative Site
      • Pavia, Italy
        • Novartis Investigative Site
      • Perugia, Italy
        • Novartis Investigative Site
      • Pesaro, Italy
        • Novartis Investigative Site
      • Pescara, Italy
        • Novartis Investigative Site
      • Pisa, Italy
        • Novartis Investigative Site
      • Reggio Calabria, Italy
        • Novartis Investigative Site
      • Reggio Emilia, Italy
        • Novartis Investigative Site
      • Rionero in Vulture, Italy
        • Novartis Investigative Site
      • Roma, Italy
        • Novartis Investigative Site
      • Ronciglione, Italy
        • Novartis Investigative Site
      • San Giovanni Rotundo, Italy
        • Novartis Investigative Site
      • Siena, Italy
        • Novartis Investigative Site
      • Tarante, Italy
        • Novartis Investigative Site
      • Torino, Italy
        • Novartis Investigative Site
      • Udine, Italy
        • Novartis Investigative Site
      • Via Pansini, Italy
        • Novartis Investigative Site
  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Novartis Investigative Site
      • Deajeon, Korea, Republic of
        • Novartis Investigative Site
      • Jeollanam-do, Korea, Republic of
        • Novartis Investigative Site
      • Pusan, Korea, Republic of
        • Novartis Investigative Site
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon
        • Novartis Investigative Site
  • Malaysia
      • Georgetown, Penang, Malaysia
        • Novartis Investigative Site
      • Kuala Lumpur, Malaysia
        • Novartis Investigative Site
      • Pulau Pinang, Malaysia
        • Novartis Investigative Site
      • Subang Jaya, Selangor, Malaysia
        • Novartis Investigative Site
  • Mexico
      • Mexico D.F., Mexico
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
      • Enschede, Netherlands
        • Novartis Investigative Site
      • Leiden, Netherlands
        • Novartis Investigative Site
      • Maastricht, Netherlands
        • Novartis Investigative Site
      • Rotterdam, Netherlands
        • Novartis Investigative Site
  • Norway
      • Oslo, Norway
        • Novartis Investigative Site
  • Poland
      • Gdansk, Poland
        • Novartis Investigative Site
      • Krakow, Poland
        • Novartis Investigative Site
      • Poznan, Poland
        • Novartis Investigative Site
      • Szczecin, Poland
        • Novartis Investigative Site
      • Warszawa, Poland
        • Novartis Investigative Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Novartis Investigative Site
      • Moscow, Russian Federation
        • Novartis Investigative Site
      • Novosibirsk, Russian Federation
        • Novartis Investigative Site
      • Saint-Petersburg, Russian Federation
        • Novartis Investigative Site
      • Samara, Russian Federation
        • Novartis Investigative Site
      • Ufa, Russian Federation
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia
        • Novartis Investigative Site
      • Kosice, Slovakia
        • Novartis Investigative Site
  • South Africa
      • Cape Town, South Africa
        • Novartis Investigative Site
      • Johannesburg, South Africa
        • Novartis Investigative Site
      • Roodepoort, Gauteng, South Africa
        • Novartis Investigative Site
  • Spain
      • Baracaldo, Pais Vasco, Spain
        • Novartis Investigative Site
      • Barcelona, Cataluna, Spain
        • Novartis Investigative Site
      • Cataluna, Spain
        • Novartis Investigative Site
      • Granada, Andalucia, Spain
        • Novartis Investigative Site
      • Las Palmas de Gran Canaria, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Malaga, Spain
        • Novartis Investigative Site
      • Murcia, Spain
        • Novartis Investigative Site
      • Salamanca, Castilla y Leon, Spain
        • Novartis Investigative Site
      • San Sabastian, Pais Vasco, Spain
        • Novartis Investigative Site
      • Santiago de Compostela, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
      • Zaragoza, Spain
        • Novartis Investigative Site
  • Sweden
      • Goteborg, Sweden
        • Novartis Investigative Site
      • Linkoping, Sweden
        • Novartis Investigative Site
      • Lund, Sweden
        • Novartis Investigative Site
      • Stockholm, Sweden
        • Novartis Investigative Site
      • Uppsala, Sweden
        • Novartis Investigative Site
  • Switzerland
      • Basel, Switzerland
        • Novartis Investigative Site
      • Bern, Switzerland
        • Novartis Investigative Site
      • Lausanne, Switzerland
        • Novartis Investigative Site
      • Zurich, Switzerland
        • Novartis Investigative Site
  • Taiwan
      • Chiayi, Taiwan
        • Novartis Investigative Site
      • Kaohsiung, Taiwan
        • Novartis Investigative Site
      • Taichung, Taiwan
        • Novartis Investigative Site
      • Tainan, Taiwan
        • Novartis Investigative Site
      • Taipei, Taiwan
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand
        • Novartis Investigative Site
  • Turkey
      • Ankara, Turkey
        • Novartis Investigative Site
      • Istanbul, Turkey
        • Novartis Investigative Site
      • Malatya, Turkey
        • Novartis Investigative Site
      • Samsun, Turkey
        • Novartis Investigative Site
  • United Kingdom
      • Cambridge, United Kingdom
        • Novartis Investigative Site
      • Leeds, United Kingdom
        • Novartis Investigative Site
      • Liverpool, United Kingdom
        • Novartis Investigative Site
      • London, United Kingdom
        • Novartis Investigative Site
      • Manchester, United Kingdom
        • Novartis Investigative Site
      • Nottingham, United Kingdom
        • Novartis Investigative Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36693
        • University of South Alabama Cancer Research Institute
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Lancaster, California, United States, 93534
        • Antelope Valley Cancer Center
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Cancer Institute
      • Washington, District of Columbia, United States, 20007-2113
        • Georgetown University Medical Center-Lombardi Cancer Center
    • Florida
      • Melbourne, Florida, United States, 32901
        • Osler Medical Inc./Osler Clinical Research
      • Miami, Florida, United States, 33176
        • Advanced Medical Specialties
      • Orange Park, Florida, United States, 32073
        • Integrated Community
      • Orlando, Florida, United States, 32804
        • Florida Hospital Cancer Institute
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center
      • Pensacola, Florida, United States, 32501
        • Hematology Oncology Assoc.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Cancer Institute
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
      • Chicago, Illinois, United States, 60612
        • Stroger Cook County Hospital
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • St. Francis Hospital & Health Centers
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Louisville Oncology Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • St. Agnes Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Grosse Pointe, Michigan, United States, 48236
        • St. John Hospital and Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Southeast Nebraska Cancer Center
      • Omaha, Nebraska, United States, 68114
        • Nebraska Methodist Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Health Sciences Center
      • Santa Fe, New Mexico, United States, 87505
        • Cancer Institute of New Mexico
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Mineola, New York, United States, 11501
        • Winthrop Hematology/Oncology
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical Center
      • New York, New York, United States, 10017
        • Memorial Sloan Kettering Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 734112
        • Cancer Care Associates
      • Tulsa, Oklahoma, United States, 74136
        • Cancer Care Associates
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Sciences University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Cancer Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
      • Charleston, South Carolina, United States, 29425
        • MUSC Hollings Cancer Center
      • Columbia, South Carolina, United States, 29203
        • Three Medical Park
      • Greenville, South Carolina, United States, 29615
        • Cancer Center Of The Carolinas
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Utah Cancer Specialists
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute

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

14 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 chronic myeloid leukemia in blast crisis, accelerated phase, or chronic phase.
  • Chronic myeloid leukemia patients who have been treated with an investigational tyrosine kinase inhibitor.
  • Laboratory values within normal limits.

Exclusion criteria:

  • Impaired cardiac function.
  • Acute or chronic liver or renal disease considered unrelated to tumor.
  • Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
  • Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval or to inhibit the metabolism of AMN107 (CYP3A4/5 inhibitors).
  • Patients with a history of another malignancy that is currently clinically significant or currently requires active intervention.

Other 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?

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

January 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 9, 2006

First Submitted That Met QC Criteria

March 9, 2006

First Posted (Estimate)

March 13, 2006

Study Record Updates

Last Update Posted (Estimate)

August 26, 2011

Last Update Submitted That Met QC Criteria

August 25, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMN107A2109

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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