A PHASE II STUDY OF MK-2206 IN PATIENTS WITH PROGRESSIVE, RECURRENT/METASTATIC ADENOID CYSTIC CARCINOMA
PRIMARY OBJECTIVES:
I. To determine the confirmed response rate in patients with progressive,
recurrent/metastatic adenoid cyst carcinoma (ACC) treated with 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.
ii. To explore potential genetic/cytogenetic/histopathologic predictors of clinical outcome
(i.e., response, PFS, OS) to MK-2206. (Exploratory) III. To explore the hypothesis that
MK-2206-mediated Akt inhibition and downregulation of c-myb protein levels in ACC tumors
correlates to clinical outcome (i.e., response, PFS, OS). (Exploratory)
OUTLINE: This is a multicenter study.
Patients receive Akt inhibitor MK2206 once weekly for 4 weeks. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor
tissue biopsies for correlative studies. Archived tumor tissue samples may be also
collected.
After completion of treatment, patients are followed up for up to 3 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete or partial response) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 32 weeks
No
Alan Thorson
Principal Investigator
Cancer and Leukemia Group B
United States: Food and Drug Administration
NCI-2012-01966
NCT01604772
August 2012
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
United Hospital | St. Paul, Minnesota 55102 |
Ridgeview Medical Center | Waconia, Minnesota 55387 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Beebe Medical Center | Lewes, Delaware 19958 |
Grandview Hospital | Dayton, Ohio 45405 |
Mercy Hospital | Coon Rapids, Minnesota 55433 |
Fairview-Southdale Hospital | Edina, Minnesota 55435 |
Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
Regions Hospital | Saint Paul, Minnesota 55101 |
Saint Francis Regional Medical Center | Shakopee, Minnesota 55379 |
Rice Memorial Hospital | Willmar, Minnesota 56201 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Wayne Hospital | Greenville, Ohio 45331 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Northwestern University | Chicago, Illinois 60611 |
Hennepin County Medical Center | Minneapolis, Minnesota |
Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah 84112 |
Metro-Minnesota CCOP | St. Louis Park, Minnesota |
Lakeview Hospital | Stillwater, Minnesota 55082 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Edna Williams Cancer Center at the Baptist Cancer Institute | Jacksonville, Florida 32207 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Unity Hospital | Fridley, Minnesota 55432 |
Saint John's Hospital - Healtheast | Maplewood, Minnesota 55109 |
Minnesota Oncology Hematology PA-Maplewood | Maplewood, Minnesota 55109 |
North Memorial Medical Health Center | Robbinsdale, Minnesota 55422 |
Park Nicollet Clinic - Saint Louis Park | Saint Louis Park, Minnesota 55416 |
Minnesota Oncology and Hematology PA-Woodbury | Woodbury, Minnesota 55125 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Good Samaritan Hospital - Dayton | Dayton, Ohio 45406 |
Dayton CCOP | Dayton, Ohio 45429 |
Samaritan North Health Center | Dayton, Ohio 45415 |
Blanchard Valley Hospital | Findlay, Ohio 45840 |
Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio 45005-1066 |
Kettering Medical Center | Kettering, Ohio 45429 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Carolinas Medical Center - Northeast | Concord, North Carolina 28025 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Carolinas Medical Center-Union | Monroe, North Carolina 28112 |
Cleveland Regional Medical Center | Shelby, North Carolina 28150 |