Sponsor : Nordic MDS group
Principal investigator: Honar Cherif
Primary endpoints: Safety and tolerability parameters including:
- Clinical and laboratory Grade 3/Grade 4 non-hematologic toxicities related to study medication.
- Increase in bone marrow and peripheral blood blast counts from baseline
- AE, SAE and interactions at increasing doses of Eltrombopag treatment in combination with Azacitidine.
Status: Final protocol 16/05/2011.
Start: In Sweden only; October, 2011.
Research support: GlaxoSmithKline
Inclusion criteria:
Adult subjects (18 years of age or older) with advanced MDS or sAML/MDS requiring treatment with Azacitidine as approved by EMEA with platelet counts < 75 x 10(9)/L at start of Azacitidine treatment.
Exclusion criteria:
According to protocol.
Treatment: Oral Eltombopag in increasing doses for aproximately 13 weeks combined with Azacitidine
Contact person: Tobias Svensson, Honar Cherif, Uppsala
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