Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma
Recurrent Oral Cavity Adenoid Cystic Carcinoma
Recurrent Salivary Gland Carcinoma
Salivary Gland Adenoid Cystic Carcinoma
Stage IVA Major Salivary Gland Carcinoma
Stage IVA Oral Cavity Adenoid Cystic Carcinoma
Stage IVB Major Salivary Gland Carcinoma
Stage IVB Oral Cavity Adenoid Cystic Carcinoma
Stage IVC Major Salivary Gland Carcinoma
Stage IVC Oral Cavity Adenoid Cystic Carcinoma
Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis
|Study Design:||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 ]
Confirmed response rate will be reported as the number of participants achieving either a complete response or partial response (using RECIST v1.1) divided by the number of evaluable participants. In order for a participant to be a confirmed objective responder, they must achieve a PR or CR on consecutive evaluations, at least 4 weeks apart.
Complete Response (CR): Disappearance of all target lesions and normalization of tumor biomarkers.
Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
- Median Progression Free Survival [ Time Frame: Time of study entry to progression or death, up to 3 years after registration ]Progression Free Survival is defined as the time from registration to the earliest date of documentation of disease progression or death. The distribution of time to progression will be estimated using the method of Kaplan-Meier.
- Overall Survival [ Time Frame: Time of study entry to death due to any cause, assessed up to 3 years from registration ]Overall Survival is defined as the time from registration to death. The distribution of survival will be estimated using the method of Kaplan-MeierEstimated using Kaplan-Meier methodology.
- Incidence of Toxicities of Akt Inhibitor MK-2206 [ Time Frame: Time to first treatment to up to 30 days after completion of treatment ]Safety will be assessed in terms of the number of participants reporting grade 3 or higher adverse events as evaluated by Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
|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|