NCT01907815

Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia

A Phase 2 Study of MEK 1/2 Inhibitor Trametinib in Combination With AKT Inhibitor GSK2141795 in Acute Myeloid Leukemia (AML) With RAS Mutations

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Recurrent Adult Acute Myeloid Leukemia
• Untreated Adult Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Akt Inhibitor GSK2141795	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Trametinib	Given PO

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2013-07-25
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

3 sites across 1 country: United States