Clinical Trial Results:
An open-label, randomized study of dasatinib vs. high-dose (800 mg) imatinib in the treatment of subjects with chronic phase chronic myeloid leukemia who have had a suboptimal response after at least 3 months of therapy with 400 mg imatinib.
Revised Protocol 03, incorporating Administrative Letter 01, Protocol Amendments 02 (Version 1.0, Dated 29-May-2007), 03 (Version 1.0, Dated 10-Oct-2007) and 04 (version 1.0, dated 10-Apr-08).
Summary
|
|
EudraCT number |
2005-005153-22 |
Trial protocol |
SE FI DK PT BE DE GB IT ES |
Global completion date |
20 Jan 2010
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
24 Dec 2016
|
First version publication date |
24 Dec 2016
|
Other versions |
|
Summary report(s) |
CA180-043_Synopsis |
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.