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

Primary Purpose

Chronic Myeloid Leukemia

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
AMN107
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Chronic Myeloid Leukemia focused on measuring Chronic myeloid leukemia, AMN 107, Imatinib resistant or intolerant, nilotinib, enact

Eligibility Criteria

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

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.

Sites / Locations

  • University of South Alabama Cancer Research Institute
  • Arizona Cancer Center
  • City of Hope National Medical Center
  • Antelope Valley Cancer Center
  • Stanford University
  • University of Colorado
  • Rocky Mountain Cancer Center
  • Georgetown University Medical Center-Lombardi Cancer Center
  • Washington Cancer Institute
  • Osler Medical Inc./Osler Clinical Research
  • Advanced Medical Specialties
  • Integrated Community
  • Florida Hospital Cancer Institute
  • MD Anderson Cancer Center
  • Hematology Oncology Assoc.
  • Emory University Cancer Institute
  • Medical College of Georgia
  • Rush University Medical Center
  • Stroger Cook County Hospital
  • University of Illinois at Chicago
  • University of Chicago Hospital
  • Loyola University Medical Center
  • St. Francis Hospital & Health Centers
  • University of Iowa Hospitals & Clinics
  • Cancer Center of Kansas
  • Louisville Oncology Research
  • LSU Health Sciences Center
  • St. Agnes Hospital
  • University of Michigan
  • Wayne State University
  • St. John Hospital and Medical Center
  • Mayo Clinic Hospital
  • Southeast Nebraska Cancer Center
  • Nebraska Methodist Cancer Center
  • Nevada Cancer Institute
  • Hackensack University Medical Center
  • University of New Mexico Health Sciences Center
  • Cancer Institute of New Mexico
  • Roswell Park Cancer Institute
  • Winthrop Hematology/Oncology
  • Memorial Sloan Kettering Cancer Center
  • Weill Cornell Medical Center
  • Mount Sinai Medical Center
  • University of Rochester Medical Center
  • Duke University
  • Wake Forest University
  • Cancer Care Associates
  • Cancer Care Associates
  • Oregon Health Sciences University
  • Western Pennsylvania Cancer Institute
  • Charleston Hematology Oncology
  • MUSC Hollings Cancer Center
  • Three Medical Park
  • Cancer Center of the Carolinas
  • The Jones Clinic
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center
  • Utah Cancer Specialists
  • Swedish Cancer Institute
  • Novartis Investigative Site
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Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 9, 2006
Last Updated
August 25, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00302016
Brief Title
Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
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.
Study Type
Expanded Access

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
No longer available
Study Start Date
January 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Chronic myeloid leukemia, AMN 107, Imatinib resistant or intolerant, nilotinib, enact

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AMN107

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
19695406
Citation
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.
Results Reference
derived

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

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