Recurrent Adult Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 2 Study of MEK 1/2 Inhibitor Trametinib in Combination With AKT Inhibitor GSK2141795 in Acute Myeloid Leukemia (AML) With RAS Mutations
This phase II trial studies how well trametinib and protein kinase B (Akt) inhibitor GSK2141795 work in treating patients with acute myeloid leukemia. Trametinib and Akt inhibitor GSK2141795 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the proportion of patients achieving complete remission (CR) or CR with
incomplete recovery of platelets (CRp) as best response within 4 cycles of therapy of
trametinib in combination with GSK2141795 (Akt inhibitor GSK2141795) in acute myeloid
leukemia (AML) patients with rat sarcoma (RAS) mutations.
SECONDARY OBJECTIVES:
I. To determine the disease-free survival of patients achieving CR/CRp. II. To determine the
duration of response of patients achieving CR/CRp. III. To determine the toxicity profile of
trametinib in combination with GSK2141795 in this patient population.
IV. To determine the biologic effects of trametinib in combination with GSK2141795 on
leukemia cells.
OUTLINE:
Patients receive trametinib orally (PO) once daily (QD) and Akt inhibitor GSK2141795 PO QD on
days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up for 12 weeks.
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