A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
PRIMARY OBJECTIVES:
I. To estimate the overall survival (OS) for patients with advanced gastric and
gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206.
SECONDARY OBJECTIVES:
I. To estimate the progression free survival (PFS) in this patient population. II. To
estimate the response rate (confirmed and unconfirmed complete response [CR] and partial
response [PR] by Response Evaluation Criteria In Solid Tumors [RECIST] 1.1) in this patient
population.
III. To assess the frequency and severity of toxicity associated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) once daily (QD), every other day, for 28
days. Courses repeat every 28 days in the absence of disease progression or unacceptable
toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival of patients treated with Akt inhibitor MK2206
Up to 2 years
No
Ramesh Ramanathan
Principal Investigator
Southwest Oncology Group
United States: Food and Drug Administration
NCI-2011-02619
NCT01260701
January 2011
Name | Location |
---|---|
Baylor College of Medicine | Houston, Texas 77030 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Loyola University Medical Center | Maywood, Illinois 60153 |
Akron General Medical Center | Akron, Ohio 44302 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Group Health Cooperative | Seattle, Washington 98112 |
Great Falls Clinic | Great Falls, Montana 59405 |
Winthrop University Hospital | Mineola, New York 11501 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Munson Medical Center | Traverse City, Michigan 49684 |
Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Adena Regional Medical Center | Chillicothe, Ohio 54601 |
Grady Memorial Hospital | Delaware, Ohio 43015 |
Fairfield Medical Center | Lancaster, Ohio 43130 |
Harborview Medical Center | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
Good Samaritan Hospital - Cincinnati | Cincinnati, Ohio 45220 |
Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
Poudre Valley Hospital | Fort Collins, Colorado 80524 |
Salina Regional Health Center | Salina, Kansas 67401 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Iredell Memorial Hospital | Statesville, North Carolina 28677 |
Grandview Hospital | Dayton, Ohio 45405 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Randolph Hospital | Asheboro, North Carolina 27203 |
Miami Valley Hospital | Dayton, Ohio 45409 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Mary Rutan Hospital | Bellefontaine, Ohio 43311 |
Wayne Hospital | Greenville, Ohio 45331 |
Knox Community Hospital | Mount Vernon, Ohio 43050 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Ben Taub General Hospital | Houston, Texas 77030 |
Greene Memorial Hospital | Xenia, Ohio 45385 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
McLeod Regional Medical Center | Florence, South Carolina 29501 |
Queen's Medical Center | Honolulu, Hawaii 96813 |
Providence Hospital | Mobile, Alabama 36608 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Saint Louis University Hospital | St. Louis, Missouri 63110-0250 |
University of Rochester | Rochester, New York 14642 |
Cascade Cancer Center | Kirkland, Washington 98034-3013 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Straub Clinic and Hospital | Honolulu, Hawaii 96813 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Licking Memorial Hospital | Newark, Ohio 43055-2899 |
Columbus CCOP | Columbus, Ohio 43206 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Virginia Mason CCOP | Seattle, Washington 98101 |
Oregon Health and Science University | Portland, Oregon 97201 |
Montana Cancer Specialists | Missoula, Montana 59807-7877 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
University of Southern California | Los Angeles, California 90033 |
Rockwood Clinic | Spokane, Washington 99220 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Castle Medical Center | Kailua, Hawaii 96734 |
Hays Medical Center | Hays, Kansas 67601 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Oncare Hawaii Inc-POB II | Honolulu, Hawaii 96813 |
Oncare Hawaii Inc-Kuakini | Honolulu, Hawaii 96817 |
University of Hawaii | Honolulu, Hawaii 96813 |
Saint Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
Reid Hospital and Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Saint Francis Hospital and Medical Center - Topeka | Topeka, Kansas 66606 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Truman Medical Center | Kansas City, Missouri 64108 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Hematology-Oncology Centers of the Northern Rockies PC | Billings, Montana 59101 |
Saint Vincent Healthcare | Billings, Montana 59101 |
Billings Clinic | Billings, Montana 59107-7000 |
Saint James Community Hospital and Cancer Treatment Center | Butte, Montana 59701 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Saint Peter's Community Hospital | Helena, Montana 59601 |
Glacier Oncology PLLC | Kalispell, Montana 59901 |
Saint Patrick Hospital - Community Hospital | Missoula, Montana 59802 |
Interlakes Foundation Inc-Rochester | Rochester, New York 14623 |
Wayne Memorial Hospital | Goldsboro, North Carolina 27534 |
Doctors Hospital | Columbus, Ohio 43228 |
Grant Medical Center | Columbus, Ohio 43215 |
Mount Carmel Health Center West | Columbus, Ohio 43222 |
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 |
Marietta Memorial Hospital | Marietta, Ohio 45750 |
Upper Valley Medical Center | Troy, Ohio 45373 |
Saint Ann's Hospital | Westerville, Ohio 43081 |
Genesis HealthCare System | Zanesville, Ohio 43701 |
Veterans Administration Medical Center | Houston, Texas 77030 |
Saint Luke's Episcopal Hospital | Houston, Texas 77030 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Columbia Basin Hematology and Oncology PLLC | Kennewick, Washington 99336 |
Evergreen Hospital Medical Center | Kirkland, Washington 98033 |
Minor and James Medical PLLC | Seattle, Washington 98104 |
The Polyclinic | Seattle, Washington 98122 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Kansas City Cancer Centers - North | Kansas City, Missouri 64154 |
Delnor Community Hospital | Geneva, Illinois 60134 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
University of Tennessee - Knoxville | Knoxville, Tennessee 37920 |
Skagit Valley Hospital | Mt. Vernon, Washington 98273 |
Evergreen Hematology and Oncology PS | Spokane, Washington 99218 |
Kansas City Cancer Centers-Southwest | Overland Park, Kansas 66210 |
Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |
Kuakini Medical Center | Honolulu, Hawaii 96817 |
Arizona Cancer Center at UMC Orange Grove | Tucson, Arizona 85704 |
Wilcox Memorial Hospital and Kauai Medical Clinic | Lihue, Hawaii 96766-1099 |
Central DuPage Hospital Cancer Center | Warrenville, Illinois 60555 |
Kansas City Cancer Center-West | Kansas City, Kansas 66112 |
Kansas City Cancer Center-Shawnee Mission | Shawnee Mission, Kansas 66204 |
Spectrum Health Reed City Hospital | Reed City, Michigan 49677 |
Kansas City Cancer Center - South | Kansas City, Missouri 64131 |
Kansas City Cancer Center-Lee's Summit | Lee's Summit, Missouri 64064 |
Saint John's Clinic-Rolla-Cancer and Hematology | Rolla, Missouri 65401 |
Southern Ohio Medical Center | Portsmouth, Ohio 45662 |
Memorial Hospital Of Martinsville | Martinsville, Virginia 24115 |
Cancer Care Center at Island Hospital | Anacortes, Washington 98221 |
Highline Medical Center-Main Campus | Burien, Washington 98166 |
Pacific Medical Center-First Hill | Seattle, Washington 98104 |
United General Hospital | Sedro-Woolley, Washington 98284 |
Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
Swedish Cancer Institute-Issaquah | Issaquah, Washington 98029 |
Cone Health Cancer Center | Greensboro, North Carolina |
Franciscan St. Francis Health | Indianapolis, Indiana 46237 |
Southwest Oncology Group | San Antonio, Texas 78245 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Via Christi Hospital-Pittsburg | Pittsburg, Kansas 66762 |
PeaceHealth Saint Joseph Medical Center | Bellingham, Washington 98225 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Springfield Regional Medical Center | Springfield, Ohio 45505 |
NEA Baptist Memorial Hospital | Jonesboro, Arkansas 72401 |
Promise Regional Medical Center-Hutchinson | Hutchinson, Kansas 65702 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
NEA Baptist Clinic-Matthews | Jonesboro, Arkansas 72401 |
OnCare Hawaii-Liliha | Honolulu, Hawaii 96817-3169 |
Saint Rose Ambulatory and Surgery Center | Great Bend, Kansas 67530 |
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |