PHASE II STUDY OF MK-2206 IN PATIENTS WITH RELAPSED LYMPHOMA
I. Determine the objective response rate (ORR) of MK-2206 (Akt inhibitor MK2206) in patients
with relapsed/refractory lymphoma.
I. Assess the progression free survival (PFS) of MK-2206 in patients with
relapsed/refractory lymphoma II. Assess the safety and tolerability of MK-2206 monotherapy
III. Examine pretreatment pAkt protein expression by immunohistochemistry, and correlate the
results with treatment response.
IV. Examine the effect of therapy on serum cytokines and chemokines that regulate the
tumor-promoting inflammatory process and/or immunity in patients with relapsed/refractory
lymphoma, and correlate the results with treatment response.
Patients receive Akt inhibitor MK2206 orally (PO) once weekly. Treatment repeats every 28
days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response (OR) rate along with its 95% confidence interval (CI) will be estimated for each patient cohort. Logistic regression will be utilized to assess the effect of patient demographic factors on OR.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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