Clinical Trials Directory

Trials / Completed

CompletedNCT01231919

MK2206 in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Leukemia

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
45 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
1 Year – 21 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: l. To estimate the maximum-tolerated dose (MTD) and/or recommended phase 2 dose of MK-2206 (Akt inhibitor MK2206) administered orally every other day (schedule 1) or once weekly (schedule 2) to children with refractory or recurrent solid malignancies, including central nervous system (CNS) tumors or lymphomas. II. To define and describe the toxicities of MK-2206 in children with refractory solid malignancies administered on this schedule. III. To assess the tolerability of MK-2206 at the solid tumor MTD in patients with recurrent or refractory leukemia. IV. To characterize the pharmacokinetics of MK-2206 in children with recurrent or refractory cancer. (exploratory) SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of MK-2206 within the confines of a phase 1 study.(exploratory) II. To evaluate biological activity of MK-2206 by measuring phosphatidylinositol 3 kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) signaling in tumor and peripheral blood mononuclear cells and measure the expression of biomarkers related to AKT activation phenotypes. (exploratory) OUTLINE: This is a dose-escalation study (part A) followed by treatment at the maximum-tolerated dose (part B). Patients receive Akt inhibitor MK2206 orally (PO) every other day (schedule 1) OR once weekly (schedule 2) on days 1-28. Treatment repeats every 28 days for up 12 courses (1 year) in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.

Conditions

Interventions

TypeNameDescription
DRUGAkt inhibitor MK2206Given PO
OTHERdiagnostic laboratory biomarker analysisCorrelative studies
OTHERpharmacological studyCorrelative studies

Timeline

Start date
2011-01-01
Primary completion
2013-04-01
First posted
2010-11-01
Last updated
2014-04-29

Locations

25 sites across 2 countries: United States, Canada

Source: ClinicalTrials.gov record NCT01231919. Inclusion in this directory is not an endorsement.