Study of LY573636-sodium in Essential Thrombocythemia and Acute Myeloid Leukemia

Exclusion Criteria

• •Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a non-myelosuppressive or myelosuppressive agent, respectively.
• •Participants with myeloproliferative disorders (for example, chronic myeloid leukemia (CML), polycythemia vera and primary myelofibrosis) other than essential thrombocythemia.
• •Have received an autologous or allogenic stem cell transplant within 75 days of the initial dose of study drug for the dose escalation phase or within 60 days of the initial dose of study drug for the dose confirmation phase. Recipients of an allogeneic stem cell transplant must have discontinued immunosuppressive therapy at least 24 hours before study drug administration with no more than Grade 1 acute graft-versus-host disease.
• •Have previously completed or withdrawn from this study or any other study investigating LY573636 sodium.
• •Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.
• •Have serious concomitant disorders, including active bacterial, fungal, or viral infection, incompatible with the study.
• •Have a second primary malignancy that could affect interpretation of results.
• •Have a known coagulopathy or bleeding disorder, other than leukemic related thrombocytopenia. Participants with severe or life-threatening bleeding refractory to platelet transfusions are also excluded from this study.
• •Major surgery within 4 weeks of study enrollment.
• •Are receiving warfarin (Coumadin).
• •Females who are pregnant or breast feeding.
• •Have known positive results of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg) or hepatitis C antibodies (HCAb).
• •Have received treatment within 28 days of the initial dose of study drug with an experimental agent for noncancerous indications that has not received regulatory approval for any indication.
• •Participants receiving amiodarone, quinidine, propofol, or clozapine.
• •Participants receiving treatment with strong or moderate inhibitors of cytochrome P450 (CYP)2C19, including proton-pump inhibitors (PPIs). Esomeprazole or pantoprazole are allowed if not administered within 72 hours before or after LY573636 administration