Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00302016




Registration number
NCT00302016
Ethics application status
Date submitted
9/03/2006
Date registered
13/03/2006
Date last updated
26/08/2011

Titles & IDs
Public title
Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
Scientific 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.
Secondary ID [1] 0 0
CAMN107A2109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - AMN107

Treatment: Drugs: AMN107
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
No longer available
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - Saint Leonards
Recruitment postcode(s) [1] 0 0
- Saint Leonards
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Nebraska
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Austria
State/province [31] 0 0
Graz
Country [32] 0 0
Austria
State/province [32] 0 0
Innsbruck
Country [33] 0 0
Austria
State/province [33] 0 0
Linz
Country [34] 0 0
Austria
State/province [34] 0 0
Wels
Country [35] 0 0
Austria
State/province [35] 0 0
Wien
Country [36] 0 0
Belgium
State/province [36] 0 0
Aalst
Country [37] 0 0
Belgium
State/province [37] 0 0
Antwerpen
Country [38] 0 0
Belgium
State/province [38] 0 0
Arlon
Country [39] 0 0
Belgium
State/province [39] 0 0
Brugge
Country [40] 0 0
Belgium
State/province [40] 0 0
Brussels
Country [41] 0 0
Belgium
State/province [41] 0 0
Bruxelles
Country [42] 0 0
Belgium
State/province [42] 0 0
Edegem
Country [43] 0 0
Belgium
State/province [43] 0 0
Gent
Country [44] 0 0
Belgium
State/province [44] 0 0
Hasselt
Country [45] 0 0
Belgium
State/province [45] 0 0
La Louviere
Country [46] 0 0
Belgium
State/province [46] 0 0
Leuven
Country [47] 0 0
Belgium
State/province [47] 0 0
Liege
Country [48] 0 0
Belgium
State/province [48] 0 0
Roeselare
Country [49] 0 0
Belgium
State/province [49] 0 0
Verviers
Country [50] 0 0
Belgium
State/province [50] 0 0
Yvoir
Country [51] 0 0
Brazil
State/province [51] 0 0
Belo Horizonte
Country [52] 0 0
Brazil
State/province [52] 0 0
Brasilia-DF
Country [53] 0 0
Brazil
State/province [53] 0 0
Campinas
Country [54] 0 0
Brazil
State/province [54] 0 0
Curitaba
Country [55] 0 0
Brazil
State/province [55] 0 0
Curitiba
Country [56] 0 0
Brazil
State/province [56] 0 0
Porto Alegre-RS
Country [57] 0 0
Brazil
State/province [57] 0 0
Ribeirao Preto
Country [58] 0 0
Brazil
State/province [58] 0 0
Rio de Janeiro
Country [59] 0 0
Brazil
State/province [59] 0 0
Sao Paulo
Country [60] 0 0
Canada
State/province [60] 0 0
Edmonton
Country [61] 0 0
Canada
State/province [61] 0 0
Halifax
Country [62] 0 0
Canada
State/province [62] 0 0
Hamilton
Country [63] 0 0
Canada
State/province [63] 0 0
Montreal
Country [64] 0 0
Canada
State/province [64] 0 0
Ottawa
Country [65] 0 0
Canada
State/province [65] 0 0
Toronto
Country [66] 0 0
Canada
State/province [66] 0 0
Vancouver
Country [67] 0 0
China
State/province [67] 0 0
Beijing
Country [68] 0 0
China
State/province [68] 0 0
Guangzhou
Country [69] 0 0
China
State/province [69] 0 0
Shanghai
Country [70] 0 0
China
State/province [70] 0 0
Tianjing
Country [71] 0 0
Czech Republic
State/province [71] 0 0
Brno
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Hradec Kralove
Country [73] 0 0
Czech Republic
State/province [73] 0 0
Olomouc
Country [74] 0 0
Czech Republic
State/province [74] 0 0
Plzen-Lochotin
Country [75] 0 0
Czech Republic
State/province [75] 0 0
Praha 2
Country [76] 0 0
Denmark
State/province [76] 0 0
Copenhagen
Country [77] 0 0
Denmark
State/province [77] 0 0
Vejle
Country [78] 0 0
France
State/province [78] 0 0
Angers
Country [79] 0 0
France
State/province [79] 0 0
Bordeaux
Country [80] 0 0
France
State/province [80] 0 0
Caen
Country [81] 0 0
France
State/province [81] 0 0
Clermont-Ferrand
Country [82] 0 0
France
State/province [82] 0 0
Creteil
Country [83] 0 0
France
State/province [83] 0 0
Dijon
Country [84] 0 0
France
State/province [84] 0 0
Grenoble
Country [85] 0 0
France
State/province [85] 0 0
Le Chesnay
Country [86] 0 0
France
State/province [86] 0 0
Lille
Country [87] 0 0
France
State/province [87] 0 0
Limoges
Country [88] 0 0
France
State/province [88] 0 0
Lyon
Country [89] 0 0
France
State/province [89] 0 0
Marseille
Country [90] 0 0
France
State/province [90] 0 0
Nantes
Country [91] 0 0
France
State/province [91] 0 0
Nice
Country [92] 0 0
France
State/province [92] 0 0
Paris
Country [93] 0 0
France
State/province [93] 0 0
Poitiers
Country [94] 0 0
France
State/province [94] 0 0
Reims
Country [95] 0 0
France
State/province [95] 0 0
Rennes
Country [96] 0 0
France
State/province [96] 0 0
Rouen
Country [97] 0 0
France
State/province [97] 0 0
Strasbourg
Country [98] 0 0
France
State/province [98] 0 0
Toulouse
Country [99] 0 0
France
State/province [99] 0 0
Vandoeuvre les Nancy
Country [100] 0 0
France
State/province [100] 0 0
Vandoeuvre
Country [101] 0 0
Germany
State/province [101] 0 0
Aschaffenburg
Country [102] 0 0
Germany
State/province [102] 0 0
Augsburg
Country [103] 0 0
Germany
State/province [103] 0 0
Berlin
Country [104] 0 0
Germany
State/province [104] 0 0
Braunschweig
Country [105] 0 0
Germany
State/province [105] 0 0
Bremen
Country [106] 0 0
Germany
State/province [106] 0 0
Bremerhaven
Country [107] 0 0
Germany
State/province [107] 0 0
Chemnitz
Country [108] 0 0
Germany
State/province [108] 0 0
Dresden
Country [109] 0 0
Germany
State/province [109] 0 0
Essen
Country [110] 0 0
Germany
State/province [110] 0 0
Frankfurt
Country [111] 0 0
Germany
State/province [111] 0 0
Freiburg
Country [112] 0 0
Germany
State/province [112] 0 0
Greifswald
Country [113] 0 0
Germany
State/province [113] 0 0
Hamburg
Country [114] 0 0
Germany
State/province [114] 0 0
Hannover
Country [115] 0 0
Germany
State/province [115] 0 0
Heidelberg
Country [116] 0 0
Germany
State/province [116] 0 0
Kiel
Country [117] 0 0
Germany
State/province [117] 0 0
Koln
Country [118] 0 0
Germany
State/province [118] 0 0
Leipzig
Country [119] 0 0
Germany
State/province [119] 0 0
Mainz
Country [120] 0 0
Germany
State/province [120] 0 0
Mannheim
Country [121] 0 0
Germany
State/province [121] 0 0
Marburg
Country [122] 0 0
Germany
State/province [122] 0 0
Munchen
Country [123] 0 0
Germany
State/province [123] 0 0
Oldenburg
Country [124] 0 0
Germany
State/province [124] 0 0
Osnabruck
Country [125] 0 0
Germany
State/province [125] 0 0
Regensburg
Country [126] 0 0
Germany
State/province [126] 0 0
Stuttgart
Country [127] 0 0
Germany
State/province [127] 0 0
Tubingen
Country [128] 0 0
Germany
State/province [128] 0 0
Ulm
Country [129] 0 0
Germany
State/province [129] 0 0
Weiden
Country [130] 0 0
Germany
State/province [130] 0 0
Wiesbaden
Country [131] 0 0
Greece
State/province [131] 0 0
Athens
Country [132] 0 0
Hong Kong
State/province [132] 0 0
Pokfulam
Country [133] 0 0
Hungary
State/province [133] 0 0
Budapest
Country [134] 0 0
Ireland
State/province [134] 0 0
Dublin
Country [135] 0 0
Italy
State/province [135] 0 0
Ancona
Country [136] 0 0
Italy
State/province [136] 0 0
Bari
Country [137] 0 0
Italy
State/province [137] 0 0
Bologna
Country [138] 0 0
Italy
State/province [138] 0 0
Bolzano
Country [139] 0 0
Italy
State/province [139] 0 0
Brescia
Country [140] 0 0
Italy
State/province [140] 0 0
Cagliari
Country [141] 0 0
Italy
State/province [141] 0 0
Campobasso
Country [142] 0 0
Italy
State/province [142] 0 0
Catania
Country [143] 0 0
Italy
State/province [143] 0 0
Catanzaro
Country [144] 0 0
Italy
State/province [144] 0 0
Ferrara
Country [145] 0 0
Italy
State/province [145] 0 0
Firenze
Country [146] 0 0
Italy
State/province [146] 0 0
Genova
Country [147] 0 0
Italy
State/province [147] 0 0
Milano
Country [148] 0 0
Italy
State/province [148] 0 0
Monza
Country [149] 0 0
Italy
State/province [149] 0 0
Napoli
Country [150] 0 0
Italy
State/province [150] 0 0
Novara
Country [151] 0 0
Italy
State/province [151] 0 0
Nuoro
Country [152] 0 0
Italy
State/province [152] 0 0
Orbassano
Country [153] 0 0
Italy
State/province [153] 0 0
Padova
Country [154] 0 0
Italy
State/province [154] 0 0
Palermo
Country [155] 0 0
Italy
State/province [155] 0 0
Pavia
Country [156] 0 0
Italy
State/province [156] 0 0
Perugia
Country [157] 0 0
Italy
State/province [157] 0 0
Pesaro
Country [158] 0 0
Italy
State/province [158] 0 0
Pescara
Country [159] 0 0
Italy
State/province [159] 0 0
Pisa
Country [160] 0 0
Italy
State/province [160] 0 0
Reggio Calabria
Country [161] 0 0
Italy
State/province [161] 0 0
Reggio Emilia
Country [162] 0 0
Italy
State/province [162] 0 0
Rionero in Vulture
Country [163] 0 0
Italy
State/province [163] 0 0
Roma
Country [164] 0 0
Italy
State/province [164] 0 0
Ronciglione
Country [165] 0 0
Italy
State/province [165] 0 0
San Giovanni Rotundo
Country [166] 0 0
Italy
State/province [166] 0 0
Siena
Country [167] 0 0
Italy
State/province [167] 0 0
Tarante
Country [168] 0 0
Italy
State/province [168] 0 0
Torino
Country [169] 0 0
Italy
State/province [169] 0 0
Udine
Country [170] 0 0
Italy
State/province [170] 0 0
Via Pansini
Country [171] 0 0
Korea, Republic of
State/province [171] 0 0
Daegu
Country [172] 0 0
Korea, Republic of
State/province [172] 0 0
Deajeon
Country [173] 0 0
Korea, Republic of
State/province [173] 0 0
Jeollanam-do
Country [174] 0 0
Korea, Republic of
State/province [174] 0 0
Pusan
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
Seoul
Country [176] 0 0
Lebanon
State/province [176] 0 0
Beirut
Country [177] 0 0
Malaysia
State/province [177] 0 0
Georgetown, Penang
Country [178] 0 0
Malaysia
State/province [178] 0 0
Kuala Lumpur
Country [179] 0 0
Malaysia
State/province [179] 0 0
Pulau Pinang
Country [180] 0 0
Malaysia
State/province [180] 0 0
Subang Jaya, Selangor
Country [181] 0 0
Mexico
State/province [181] 0 0
Mexico D.F.
Country [182] 0 0
Netherlands
State/province [182] 0 0
Amsterdam
Country [183] 0 0
Netherlands
State/province [183] 0 0
Enschede
Country [184] 0 0
Netherlands
State/province [184] 0 0
Leiden
Country [185] 0 0
Netherlands
State/province [185] 0 0
Maastricht
Country [186] 0 0
Netherlands
State/province [186] 0 0
Rotterdam
Country [187] 0 0
Norway
State/province [187] 0 0
Oslo
Country [188] 0 0
Poland
State/province [188] 0 0
Gdansk
Country [189] 0 0
Poland
State/province [189] 0 0
Krakow
Country [190] 0 0
Poland
State/province [190] 0 0
Poznan
Country [191] 0 0
Poland
State/province [191] 0 0
Szczecin
Country [192] 0 0
Poland
State/province [192] 0 0
Warszawa
Country [193] 0 0
Russian Federation
State/province [193] 0 0
Chelyabinsk
Country [194] 0 0
Russian Federation
State/province [194] 0 0
Moscow
Country [195] 0 0
Russian Federation
State/province [195] 0 0
Novosibirsk
Country [196] 0 0
Russian Federation
State/province [196] 0 0
Saint-Petersburg
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Samara
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Ufa
Country [199] 0 0
Singapore
State/province [199] 0 0
Singapore
Country [200] 0 0
Slovakia
State/province [200] 0 0
Bratislava
Country [201] 0 0
Slovakia
State/province [201] 0 0
Kosice
Country [202] 0 0
South Africa
State/province [202] 0 0
Cape Town
Country [203] 0 0
South Africa
State/province [203] 0 0
Johannesburg
Country [204] 0 0
South Africa
State/province [204] 0 0
Roodepoort, Gauteng
Country [205] 0 0
Spain
State/province [205] 0 0
Baracaldo, Pais Vasco
Country [206] 0 0
Spain
State/province [206] 0 0
Barcelona, Cataluna
Country [207] 0 0
Spain
State/province [207] 0 0
Cataluna
Country [208] 0 0
Spain
State/province [208] 0 0
Granada, Andalucia
Country [209] 0 0
Spain
State/province [209] 0 0
Las Palmas de Gran Canaria
Country [210] 0 0
Spain
State/province [210] 0 0
Madrid
Country [211] 0 0
Spain
State/province [211] 0 0
Malaga
Country [212] 0 0
Spain
State/province [212] 0 0
Murcia
Country [213] 0 0
Spain
State/province [213] 0 0
Salamanca, Castilla y Leon
Country [214] 0 0
Spain
State/province [214] 0 0
San Sabastian, Pais Vasco
Country [215] 0 0
Spain
State/province [215] 0 0
Santiago de Compostela
Country [216] 0 0
Spain
State/province [216] 0 0
Valencia
Country [217] 0 0
Spain
State/province [217] 0 0
Zaragoza
Country [218] 0 0
Sweden
State/province [218] 0 0
Goteborg
Country [219] 0 0
Sweden
State/province [219] 0 0
Linkoping
Country [220] 0 0
Sweden
State/province [220] 0 0
Lund
Country [221] 0 0
Sweden
State/province [221] 0 0
Stockholm
Country [222] 0 0
Sweden
State/province [222] 0 0
Uppsala
Country [223] 0 0
Switzerland
State/province [223] 0 0
Basel
Country [224] 0 0
Switzerland
State/province [224] 0 0
Bern
Country [225] 0 0
Switzerland
State/province [225] 0 0
Lausanne
Country [226] 0 0
Switzerland
State/province [226] 0 0
Zurich
Country [227] 0 0
Taiwan
State/province [227] 0 0
Chiayi
Country [228] 0 0
Taiwan
State/province [228] 0 0
Kaohsiung
Country [229] 0 0
Taiwan
State/province [229] 0 0
Taichung
Country [230] 0 0
Taiwan
State/province [230] 0 0
Tainan
Country [231] 0 0
Taiwan
State/province [231] 0 0
Taipei
Country [232] 0 0
Thailand
State/province [232] 0 0
Bangkok
Country [233] 0 0
Turkey
State/province [233] 0 0
Ankara
Country [234] 0 0
Turkey
State/province [234] 0 0
Istanbul
Country [235] 0 0
Turkey
State/province [235] 0 0
Malatya
Country [236] 0 0
Turkey
State/province [236] 0 0
Samsun
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Cambridge
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Leeds
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Liverpool
Country [240] 0 0
United Kingdom
State/province [240] 0 0
London
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Manchester
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00302016
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00302016