Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst 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.
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Salivary Gland Cancer
Salivary Gland Adenoid Cystic Carcinoma
Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVA Salivary Gland Cancer
Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVB Salivary Gland Cancer
Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
Stage IVC Salivary Gland Cancer
Drug: Akt inhibitor MK2206
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of MK-2206 in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma|
- Confirmed response rate (complete response + partial response) according to RECIST version 1.1 [ Time Frame: Up to 32 weeks ] [ Designated as safety issue: No ]
- Median PFS [ Time Frame: Time of study entry to the first disease progression or death, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using Kaplan-Meier methodology.
- Overall OS [ Time Frame: Time of study entry to death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]Estimated using Kaplan-Meier methodology.
- Incidence of toxicities of Akt Inhibitor MK-2206 as assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Time to first treatment to up to 30 days after completion of treatment ] [ Designated as safety issue: Yes ]Safety will be assessed in terms of adverse events (AEs), laboratory data and vital sign data, which will be collected for all patients. The number of patients experiencing each AE will be summarized.
|Study Start Date:||July 2012|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Akt inhibitor MK2206)
Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Akt inhibitor MK2206
Other Name: MK2206Other: laboratory biomarker analysis
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).
I. To evaluate the progression-free survival (PFS), overall survival (OS), and safety/tolerability for MK-2206 in these patients.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604772
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|Principal Investigator:||Alan Ho||Alliance for Clinical Trials in Oncology|