Recurrent Salivary Gland Carcinoma Clinical Trial
Official title:
A Phase II Study of MK-2206 in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
This phase II trial studies how well Akt inhibitor MK2206 works in treating patients with progressive, recurrent, or metastatic adenoid cyst carcinoma (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 confirmed response rate of patients with progressive,
recurrent/metastatic adenoid cyst carcinoma (ACC) treated with v-akt murine thymoma viral
oncogene homolog 1 (Akt) inhibitor MK2206 (MK-2206).
SECONDARY OBJECTIVES:
I. To evaluate the progression-free survival (PFS), overall survival (OS), and
safety/tolerability for MK-2206 in these patients.
TERTIARY OBJECTIVES:
I. To explore potential genetic/cytogenetic/histopathologic predictors of clinical outcome
(i.e., response, PFS, OS) to MK-2206.
II. To explore the hypothesis that MK-2206-mediated Akt inhibition and downregulation of
v-myb avian myeloblastosis viral oncogene homolog (c-myb) protein levels in ACC tumors
correlates to clinical outcome (i.e., response, PFS, OS).
OUTLINE:
Patients receive Akt inhibitor MK2206 orally (PO) once weekly for 4 weeks. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of treatment, patients are followed up every 6 months for up to 3 years.
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