12
Participants
Start Date
October 31, 2011
Primary Completion Date
May 31, 2013
Study Completion Date
May 31, 2013
Eltrombopag
In this study 4 different doses of oral eltrombopag (50mg, 100mg, 200mg and 300mg) will be tested. A modified 3+3 patient cohorts design will be used so no new patients are accepted to start on a higher dose without prior tolerance at the previous dose. Patients will be given eltrombopag once daily starting one week before the start of azacitidine treatment and then continue throughout the study, which duration will be approximately 3 months (three Azacytidine cycles). Patients will be evaluated continuously by clinical and laboratory assessments as well as bone marrow examinations during the treatment period until 4 weeks after discontinuation of Eltrombopag. Response, AEs/SAEs and DLTs will be monitored throughout the study.
4 Locations, Uppsala, Stockholm, Göteborg, Umeå
Collaborators (1)
GlaxoSmithKline
INDUSTRY
Nordic MDS Group
NETWORK