A Phase I Study of MK-2206, an AKT Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors or Leukemia

NCT01231919 Phase 1 COMPLETED

This phase I trial is studying the side effects, best way to give, and best dose of Akt inhibitor MK2206 (MK2206) in treating patients with recurrent or refractory solid tumors or leukemia. MK2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	COMPLETED
Enrolment	45
Start date	2011-01

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia
• Acute Leukemias of Ambiguous Lineage
• Acute Myeloid Leukemia/Transient Myeloproliferative Disorder
• Acute Undifferentiated Leukemia
• Aggressive NK-cell Leukemia
• Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
• Blastic Phase Chronic Myelogenous Leukemia
• Blastic Plasmacytoid Dendritic Cell Neoplasm
• Childhood Burkitt Lymphoma
• Childhood Chronic Myelogenous Leukemia

Interventions

• Akt inhibitor MK2206
• diagnostic laboratory biomarker analysis
• pharmacological study

Primary outcomes

• MTD and/or recommended phase 2 dose of Akt inhibitor MK2206 determined according to incidence of dose-limiting toxicities (DLTs) graded using CTCAE v4.0 (Part A) — 28 days
  The MTD will be the maximum dose at which fewer than one-third of patients experience DLT during course 1 of therapy.

Countries

United States, Canada