Safety Study of Eltrombopag Combined With Azacitidine to Treat Myelodysplastic Syndrome (MDS)

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

May 31, 2013

Study Completion Date

May 31, 2013

Conditions
Myelodysplastic SyndromeThrombocytopenia
Interventions
DRUG

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.

Trial Locations (1)

Unknown

4 Locations, Uppsala, Stockholm, Göteborg, Umeå

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Nordic MDS Group

NETWORK

NCT01481220 - Safety Study of Eltrombopag Combined With Azacitidine to Treat Myelodysplastic Syndrome (MDS) | Biotech Hunter | Biotech Hunter