Stage IV Squamous Cell Carcinoma of the Nasopharynx Clinical Trial
Official title:
Multicenter Phase II Study of MK-2206 in Previously Treated Patients With Recurrent and Metastatic Nasopharyngeal Carcinoma
This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with recurrent or metastatic head and neck cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine the proportion of patients alive and progression-free at 6 months along with
the confirmed response rate as a dual primary endpoint..
SECONDARY OBJECTIVES:
I. To evaluate best response and duration of response for patients treated with MK2206 (Akt
inhibitor MK2206).
II. To evaluate the overall survival and progression-free survival (PFS) of patients treated
with MK2206.
III. To evaluate safety and tolerability of MK2206.
TERTIARY OBJECTIVES:
I. To evaluate the pharmacokinetics of MK2206 in Asian patients. II. To study the
pharmacodynamic effect of MK2206 using biomarkers and correlation with cancer-related
outcomes.
OUTLINE: This is a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection at baseline and periodically during study for
pharmacogenomic and pharmacokinetic studies.
After completion of study therapy, patients are followed up for up to 3 years.
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