A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Open-label, sequential dose escalation and expansion study of AMG 232 in subjects with acute myeloid leukemia.

Inclusion Criteria:

• Men or women > 18 years old
• Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
• Ability to take oral medications and willing to record daily adherance to investigational product
• Adequate hematological, renal, hepatic, and coagulation laboratory assessments

Exclusion Criteria:

• Active infection requiring intravenous (IV) antibiotics
• Prior participation in an investigational study (procedure or device) within 21 days of study day 1
• Major surgery within 28 days of study day 1
• Anti-tumor therapy within 14 days of study day 1