Chronic Myelomonocytic Leukemia Clinical Trial
Official title:
A Phase I Study of MK-2206, an AKT Inhibitor, in Pediatric Patients With Recurrent or Refractory Solid Tumors or Leukemia
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.
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.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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