Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
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.
Age
1–21
Sex
ALL
Healthy volunteers
Not accepted
