NCT01604772

Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma

A Phase II Study of MK-2206 in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Recurrent Oral Cavity Adenoid Cystic Carcinoma
• Recurrent Salivary Gland Carcinoma
• Salivary Gland Adenoid Cystic Carcinoma
• 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

Interventions

Type	Name	Description
DRUG	Akt Inhibitor MK2206	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies

Timeline

• Start date: 2012-07-23
• Primary completion: 2013-10-24
• Completion: 2014-11-22
• First posted: 2012-05-24
• Last updated: 2019-05-01
• Results posted: 2015-06-26

Locations

51 sites across 1 country: United States