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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Recurrent Oral Cavity Adenoid Cystic Carcinoma
  • Recurrent Salivary Gland Carcinoma
  • Salivary Gland Adenoid Cystic Carcinoma
  • Salivary Gland Neoplasms
  • Stage IVA Major Salivary Gland Cancer AJCC v7
  • Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
  • Stage IVB Major Salivary Gland Cancer AJCC v7
  • Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
  • Stage IVC Major Salivary Gland Cancer AJCC v7
  • Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7

NCT number NCT01604772
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date July 23, 2012
Completion date November 22, 2014

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