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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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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.
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Secondary ID [1]
0
0
CAMN107A2109
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia
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0
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Condition category
Condition code
Cancer
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0
0
0
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Leukaemia - Acute leukaemia
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Cancer
0
0
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0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
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0
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Expanded Access
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
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Allocation to intervention
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Phase
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Statistical methods / analysis
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Recruitment
Recruitment status
NO_LONGER_AVAILABLE
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2006
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Anticipated
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Actual
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Actual
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Sample size
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Final
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Recruitment in Australia
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Recruitment hospital [1]
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Novartis Investigative Site - Saint Leonards
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Recruitment postcode(s) [1]
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- Saint Leonards
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Italy
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Pisa
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Italy
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Italy
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Italy
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Italy
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Italy
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Tarante
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Italy
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Torino
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Italy
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Udine
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Italy
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Daegu
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Leiden
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Russian Federation
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Novosibirsk
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Russian Federation
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Russian Federation
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Ufa
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Johannesburg
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South Africa
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Roodepoort, Gauteng
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Las Palmas de Gran Canaria
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Malaga
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Murcia
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Santiago de Compostela
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Valencia
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Zaragoza
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Goteborg
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Linkoping
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Lund
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Stockholm
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Uppsala
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Bern
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Lausanne
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Istanbul
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Malatya
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Samsun
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Cambridge
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Leeds
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United Kingdom
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Nottingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00302016
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00302016
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