Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)

This study will evaluate the safety and tolerability of eltrombopag in the treatment of low
platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary
acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or
ineligible to receive azacitidine, decitabine, intensive chemotherapy or
autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in
which patients will receive study medication daily for 6 months, during which time the dose
of study medication may be adjusted based upon individual platelet counts and bone marrow
blast counts. All subjects will receive best standard of care (platelet transfusions, mild
chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition
to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag
treatment if a clinically and statistically significant improvement in bone marrow blast
counts is seen in subjects treated with eltrombopag.