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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00302016
First received: March 9, 2006
Last updated: August 25, 2011
Last verified: August 2011
History of Changes

March 9, 2006
August 25, 2011
January 2006
November 2008   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00302016 on ClinicalTrials.gov Archive Site
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Expanded Access Program of AMN107 in Imatinib-resistant or Intolerant Adult Patients With Chronic Myeloid Leukemia
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.
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Expanded Access
Phase 3
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Chronic Myeloid Leukemia
Drug: AMN107
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
No longer available
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November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Italy,   Korea, Republic of,   Lebanon,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Russian Federation,   Singapore,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom
 
NCT00302016
CAMN107A2109
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP