Spots Global Cancer Trial Database for Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma
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Trial Identification
Brief Title: Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma
Official Title: A Phase II Study of MK-2206 in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Study ID: NCT01604772
Conditions
Study Description
Brief 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Franciscan Health Indianapolis, Indianapolis, Indiana, United States
Reid Health, Richmond, Indiana, United States
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
Mercy Medical Center-Sioux City, Sioux City, Iowa, United States
Saint Luke's Regional Medical Center, Sioux City, Iowa, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Hutchinson Area Health Care, Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium, Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Carolinas HealthCare System NorthEast, Concord, North Carolina, United States
Carolinas HealthCare System Union, Monroe, North Carolina, United States
Carolinas HealthCare System Cleveland, Shelby, North Carolina, United States
Grandview Hospital, Dayton, Ohio, United States
Good Samaritan Hospital - Dayton, Dayton, Ohio, United States
Miami Valley Hospital, Dayton, Ohio, United States
Samaritan North Health Center, Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program, Dayton, Ohio, United States
Blanchard Valley Hospital, Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital, Franklin, Ohio, United States
Wayne Hospital, Greenville, Ohio, United States
Kettering Medical Center, Kettering, Ohio, United States
Upper Valley Medical Center, Troy, Ohio, United States
Greene Memorial Hospital, Xenia, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Contact Details
Name: Alan Ho
Affiliation: Alliance for Clinical Trials in Oncology
Role: PRINCIPAL_INVESTIGATOR
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