Clinical Trial Results:
A phase III multi-center, open-label, randomized study of the efficacy of nilotinib versus imatinib in adult patients with Philadelphia chromosome positive (Ph+ ) chronic myelogenous leukemia in chronic phase (CML - CP) who have suboptimal cytogenetic response (CyR) on imatinib.
Summary
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EudraCT number |
2005-005047-26 |
Trial protocol |
BE CZ ES DE IT NL HU FR GR |
Global completion date |
24 Mar 2009
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
31 Mar 2016
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First version publication date |
31 Mar 2016
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Other versions |
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Summary report(s) |
CAMN107A2302_CT_gov_results |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.