AzTrials
AzTrials

Chronic Myeloid LeukemiaNCT00302016

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

A study testing AMN107 in people with Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 270 sites in 34 countries.

No Longer Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Myeloid Leukemia
What is being tested?
AMN107
How many people
Not given
Where
270 sitesin 34 countries
Study dates
Jan 2006to Nov 2008
Phase
Expanded access
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

270 sites in 34 countries.

270 sites in 34 countries

United States59 sites

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University Cancer Institute

    Atlanta, Georgia, 30322

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • University of Colorado

    Aurora, Colorado, 80010

  • St. Agnes Hospital

    Baltimore, Maryland, 21229

  • St. Francis Hospital & Health Centers

    Beech Grove, Indiana, 46107

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29403

  • MUSC Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Stroger Cook County Hospital

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • Three Medical Park

    Columbia, South Carolina, 29203

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218

  • Wayne State University

    Detroit, Michigan, 48201

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Duke University

    Durham, North Carolina, 27710

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Cancer Center of the Carolinas

    Greenville, South Carolina, 29615

  • St. John Hospital and Medical Center

    Grosse Pointe, Michigan, 48236

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Antelope Valley Cancer Center

    Lancaster, California, 93534

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68516

  • Louisville Oncology Research

    Louisville, Kentucky, 40202

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Osler Medical Inc./Osler Clinical Research

    Melbourne, Florida, 32901

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Winthrop Hematology/Oncology

    Mineola, New York, 11501

  • University of South Alabama Cancer Research Institute

    Mobile, Alabama, 36693

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10017

  • Weill Cornell Medical Center

    New York, New York, 10021

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Cancer Care Associates

    Oklahoma City, Oklahoma, 734112

  • Nebraska Methodist Cancer Center

    Omaha, Nebraska, 68114

  • Integrated Community

    Orange Park, Florida, 32073

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • MD Anderson Cancer Center

    Orlando, Florida, 32806

  • Stanford University

    Palo Alto, California, 94304

  • Hematology Oncology Assoc.

    Pensacola, Florida, 32501

  • Western Pennsylvania Cancer Institute

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Mayo Clinic Hospital

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Cancer Institute of New Mexico

    Santa Fe, New Mexico, 87505

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Georgetown University Medical Center-Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007-2113

  • Washington Cancer Institute

    Washington D.C., District of Columbia, 20010

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

Italy36 sites

  • Novartis Investigative Site

    Ancona

  • Novartis Investigative Site

    Bari

  • Novartis Investigative Site

    Bologna

  • Novartis Investigative Site

    Bolzano

  • Novartis Investigative Site

    Brescia

  • Novartis Investigative Site

    Cagliari

  • Novartis Investigative Site

    Campobasso

  • Novartis Investigative Site

    Catania

  • Novartis Investigative Site

    Catanzaro

  • Novartis Investigative Site

    Ferrara

  • Novartis Investigative Site

    Florence

  • Novartis Investigative Site

    Genova

  • Novartis Investigative Site

    Milan

  • Novartis Investigative Site

    Monza

  • Novartis Investigative Site

    Naples

  • Novartis Investigative Site

    Novara

  • Novartis Investigative Site

    Nuoro

  • Novartis Investigative Site

    Orbassano

  • Novartis Investigative Site

    Padova

  • Novartis Investigative Site

    Palermo

  • Novartis Investigative Site

    Pavia

  • Novartis Investigative Site

    Perugia

  • Novartis Investigative Site

    Pesaro

  • Novartis Investigative Site

    Pescara

  • Novartis Investigative Site

    Pisa

  • Novartis Investigative Site

    Reggio Calabria

  • Novartis Investigative Site

    Reggio Emilia

  • Novartis Investigative Site

    Rionero in Vulture

  • Novartis Investigative Site

    Roma

  • Novartis Investigative Site

    Ronciglione

  • Novartis Investigative Site

    San Giovanni Rotundo

  • Novartis Investigative Site

    Siena

  • Novartis Investigative Site

    Tarante

  • Novartis Investigative Site

    Torino

  • Novartis Investigative Site

    Udine

  • Novartis Investigative Site

    Via Pansini

Other trials in Italy

Germany30 sites

  • Novartis Investigative Site

    Aschaffenburg

  • Novartis Investigative Site

    Augsburg

  • Novartis Investigative Site

    Berlin

  • Novartis Investigative Site

    Braunschweig

  • Novartis Investigative Site

    Bremen

  • Novartis Investigative Site

    Bremerhaven

  • Novartis Investigative Site

    Chemnitz

  • Novartis Investigative Site

    Cologne

  • Novartis Investigative Site

    Dresden

  • Novartis Investigative Site

    Essen

  • Novartis Investigative Site

    Frankfurt

  • Novartis Investigative Site

    Freiburg im Breisgau

  • Novartis Investigative Site

    Greifswald

  • Novartis Investigative Site

    Hamburg

  • Novartis Investigative Site

    Hanover

  • Novartis Investigative Site

    Heidelberg

  • Novartis Investigative Site

    Kiel

  • Novartis Investigative Site

    Leipzig

  • Novartis Investigative Site

    Mainz

  • Novartis Investigative Site

    Mannheim

  • Novartis Investigative Site

    Marburg

  • Novartis Investigative Site

    München

  • Novartis Investigative Site

    Oldenburg

  • Novartis Investigative Site

    Osnabrück

  • Novartis Investigative Site

    Regensburg

  • Novartis Investigative Site

    Stuttgart

  • Novartis Investigative Site

    Tübingen

  • Novartis Investigative Site

    Ulm

  • Novartis Investigative Site

    Weiden

  • Novartis Investigative Site

    Wiesbaden

Other trials in Germany

France22 sites

  • Novartis Investigative Site

    Angers

  • Novartis Investigative Site

    Bordeaux

  • Novartis Investigative Site

    Caen

  • Novartis Investigative Site

    Clermont-Ferrand

  • Novartis Investigative Site

    Créteil

  • Novartis Investigative Site

    Dijon

  • Novartis Investigative Site

    Grenoble

  • Novartis Investigative Site

    Le Chesnay

  • Novartis Investigative Site

    Lille

  • Novartis Investigative Site

    Limoges

  • Novartis Investigative Site

    Lyon

  • Novartis Investigative Site

    Marseille

  • Novartis Investigative Site

    Nantes

  • Novartis Investigative Site

    Nice

  • Novartis Investigative Site

    Paris

  • Novartis Investigative Site

    Poitiers

  • Novartis Investigative Site

    Reims

  • Novartis Investigative Site

    Rennes

  • Novartis Investigative Site

    Rouen

  • Novartis Investigative Site

    Strasbourg

  • Novartis Investigative Site

    Toulouse

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy

Other trials in France

Belgium14 sites

  • Novartis Investigative Site

    Aalst

  • Novartis Investigative Site

    Antwerp

  • Novartis Investigative Site

    Arlon

  • Novartis Investigative Site

    Bruges

  • Novartis Investigative Site

    Brussels

  • Novartis Investigative Site

    Edegem

  • Novartis Investigative Site

    Ghent

  • Novartis Investigative Site

    Hasselt

  • Novartis Investigative Site

    La Louvière

  • Novartis Investigative Site

    Leuven

  • Novartis Investigative Site

    Liège

  • Novartis Investigative Site

    Roeselare

  • Novartis Investigative Site

    Verviers

  • Novartis Investigative Site

    Yvoir

Other trials in Belgium

Spain13 sites

  • Novartis Investigative Site

    Baracaldo, Pais Vasco

  • Novartis Investigative Site

    Barcelona, Cataluna

  • Novartis Investigative Site

    Cataluna

  • Novartis Investigative Site

    Granada, Andalucia

  • Novartis Investigative Site

    Las Palmas de Gran Canaria

  • Novartis Investigative Site

    Madrid

  • Novartis Investigative Site

    Málaga

  • Novartis Investigative Site

    Murcia

  • Novartis Investigative Site

    Salamanca, Castilla Y Leon

  • Novartis Investigative Site

    San Sabastian, Pais Vasco

  • Novartis Investigative Site

    Santiago de Compostela

  • Novartis Investigative Site

    Valencia

  • Novartis Investigative Site

    Zaragoza

Other trials in Spain

Brazil9 sites

  • Novartis Investigative Site

    Belo Horizonte

  • Novartis Investigative Site

    Brasilia-DF

  • Novartis Investigative Site

    Campinas

  • Novartis Investigative Site

    Curitaba

  • Novartis Investigative Site

    Curitiba

  • Novartis Investigative Site

    Porto Alegre-RS

  • Novartis Investigative Site

    Ribeirão Preto

  • Novartis Investigative Site

    Rio de Janeiro

  • Novartis Investigative Site

    São Paulo

Other trials in Brazil

Canada7 sites

  • Novartis Investigative Site

    Edmonton

  • Novartis Investigative Site

    Halifax

  • Novartis Investigative Site

    Hamilton

  • Novartis Investigative Site

    Montreal

  • Novartis Investigative Site

    Ottawa

  • Novartis Investigative Site

    Toronto

  • Novartis Investigative Site

    Vancouver

Other trials in Canada

Russia6 sites

  • Novartis Investigative Site

    Chelyabinsk

  • Novartis Investigative Site

    Moscow

  • Novartis Investigative Site

    Novosibirsk

  • Novartis Investigative Site

    Saint Petersburg

  • Novartis Investigative Site

    Samara

  • Novartis Investigative Site

    Ufa

Other trials in Russia

United Kingdom6 sites

  • Novartis Investigative Site

    Cambridge

  • Novartis Investigative Site

    Leeds

  • Novartis Investigative Site

    Liverpool

  • Novartis Investigative Site

    London

  • Novartis Investigative Site

    Manchester

  • Novartis Investigative Site

    Nottingham

Other trials in United Kingdom

Austria5 sites

  • Novartis Investigative Site

    Graz

  • Novartis Investigative Site

    Innsbruck

  • Novartis Investigative Site

    Linz

  • Novartis Investigative Site

    Vienna

  • Novartis Investigative Site

    Wels

Other trials in Austria

Czechia5 sites

  • Novartis Investigative Site

    Brno

  • Novartis Investigative Site

    Hradec Králové

  • Novartis Investigative Site

    Olomouc

  • Novartis Investigative Site

    Plzen-Lochotin

  • Novartis Investigative Site

    Prague

Other trials in Czechia

Netherlands5 sites

  • Novartis Investigative Site

    Amsterdam

  • Novartis Investigative Site

    Enschede

  • Novartis Investigative Site

    Leiden

  • Novartis Investigative Site

    Maastricht

  • Novartis Investigative Site

    Rotterdam

Other trials in Netherlands

Poland5 sites

  • Novartis Investigative Site

    Gdansk

  • Novartis Investigative Site

    Krakow

  • Novartis Investigative Site

    Poznan

  • Novartis Investigative Site

    Szczecin

  • Novartis Investigative Site

    Warsaw

Other trials in Poland

South Korea5 sites

  • Novartis Investigative Site

    Daegu

  • Novartis Investigative Site

    Deajeon

  • Novartis Investigative Site

    Jeollanam-do

  • Novartis Investigative Site

    Pusan

  • Novartis Investigative Site

    Seoul

Other trials in South Korea

Sweden5 sites

  • Novartis Investigative Site

    Gothenburg

  • Novartis Investigative Site

    Linköping

  • Novartis Investigative Site

    Lund

  • Novartis Investigative Site

    Stockholm

  • Novartis Investigative Site

    Uppsala

Other trials in Sweden

Taiwan5 sites

  • Novartis Investigative Site

    Chiayi City

  • Novartis Investigative Site

    Kaohsiung City

  • Novartis Investigative Site

    Taichung

  • Novartis Investigative Site

    Tainan

  • Novartis Investigative Site

    Taipei

Other trials in Taiwan

China4 sites

  • Novartis Investigative Site

    Beijing

  • Novartis Investigative Site

    Guangzhou

  • Novartis Investigative Site

    Shanghai

  • Novartis Investigative Site

    Tianjing

Other trials in China

Malaysia4 sites

  • Novartis Investigative Site

    Georgetown, Penang

  • Novartis Investigative Site

    Kuala Lumpur

  • Novartis Investigative Site

    Pulau Pinang

  • Novartis Investigative Site

    Subang Jaya, Selangor

Other trials in Malaysia

Switzerland4 sites

  • Novartis Investigative Site

    Basel

  • Novartis Investigative Site

    Bern

  • Novartis Investigative Site

    Lausanne

  • Novartis Investigative Site

    Zurich

Other trials in Switzerland

Turkey (Türkiye)4 sites

  • Novartis Investigative Site

    Ankara

  • Novartis Investigative Site

    Istanbul

  • Novartis Investigative Site

    Malatya

  • Novartis Investigative Site

    Samsun

Other trials in Turkey (Türkiye)

South Africa3 sites

  • Novartis Investigative Site

    Cape Town

  • Novartis Investigative Site

    Johannesburg

  • Novartis Investigative Site

    Roodepoort, Gauteng

Other trials in South Africa

Denmark2 sites

  • Novartis Investigative Site

    Copenhagen

  • Novartis Investigative Site

    Vejle

Other trials in Denmark

Slovakia2 sites

  • Novartis Investigative Site

    Bratislava

  • Novartis Investigative Site

    Košice

Other trials in Slovakia

Australia1 site

  • Novartis Investigative Site

    Saint Leonards

Other trials in Australia

Greece1 site

  • Novartis Investigative Site

    Athens

Other trials in Greece

Hong Kong1 site

  • Novartis Investigative Site

    Pokfulam

Other trials in Hong Kong

Hungary1 site

  • Novartis Investigative Site

    Budapest

Other trials in Hungary

Ireland1 site

  • Novartis Investigative Site

    Dublin

Other trials in Ireland

Lebanon1 site

  • Novartis Investigative Site

    Beirut

Other trials in Lebanon

Mexico1 site

  • Novartis Investigative Site

    Mexico City

Other trials in Mexico

Norway1 site

  • Novartis Investigative Site

    Oslo

Other trials in Norway

Singapore1 site

  • Novartis Investigative Site

    Singapore

Other trials in Singapore

Thailand1 site

  • Novartis Investigative Site

    Bangkok

Other trials in Thailand

About this study

Official title: 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.

Being tested
AMN107
Keywords
Chronic myeloid leukemia, AMN 107, Imatinib resistant or intolerant, nilotinib, enact
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMN107Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2006 (estimated)
  2. Study startJan 2006
  3. Primary completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00302016
Sponsor's protocol ID
CAMN107A2109
Status last verified
Aug 2011
First submitted
9 Mar 2006
Last updated
26 Aug 2011
Results posted
No

Publications

  • Zhou L, Meng F, Yin O, Wang J, Wang Y, Wei Y, Hu P, Shen Z. Nilotinib for imatinib-resistant or -intolerant chronic myeloid leukemia in chronic phase, accelerated phase, or blast crisis: a single- and multiple-dose, open-label pharmacokinetic study in Chinese patients. Clin Ther. 2009 Jul;31(7):1568-75. doi: 10.1016/j.clinthera.2009.07.016.

    PubMed 19695406

Questions about this trial

What is this clinical trial studying?

A study testing AMN107 in people with Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 270 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in United States, Italy, Germany, France, Belgium and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00302016, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in