Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer
A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
6 other identifiers
interventional
75
2 countries
187
Brief Summary
This phase II clinical trial studies how well Akt inhibitor MK2206 works in treating patients with advanced gastric or gastroesophageal junction cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2011
Typical duration for phase_2
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2010
CompletedFirst Posted
Study publicly available on registry
December 15, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedJanuary 18, 2016
November 1, 2015
3.3 years
December 14, 2010
July 7, 2014
December 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival (OS)
Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Up to 2 years
Secondary Outcomes (3)
Progression Free Survival (PFS)
Up to 2 years
Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Up to 2 years
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Up to 2 years
Study Arms (1)
Treatment (CLOSED TO ACCRUAL 05/01/13)
EXPERIMENTALPatients receive Akt inhibitor MK2206 PO every other day on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction that has progressed after first-line treatment, or is recurrent within 6 months after receiving adjuvant therapy; patients must have had exactly one prior systemic treatment regimen; previous adjuvant (chemotherapy \[chemo\]) radiotherapy is permitted; prior chemotherapy given concurrently with radiation for radiosensitization is not considered one prior systemic regimen
- Patients must have measurable disease; computed tomography (CT) scans or magnetic resonance imaging (MRIs) used to assess measurable disease must have been completed within 28 days prior to registration; CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)
- Patients must not have known brain metastases
- Patients must not have received chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration
- Patient must not have received prior treatment with a phosphatidylinositol 3 (PI3), v-akt murine thymoma viral oncogene homolog 1 (AKT) or mechanistic target of rapamycin (Mtor) inhibitor for any reason
- All toxicities from prior therapy must have resolved to =\< grade 1 (Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0) prior to registration
- Patients must not be receiving or planning to receive any other investigational agents
- Patients must be able to tolerate oral medications and must not have malabsorption or chronic diarrhea (CTCAE version 4.0 grade 2 or higher); administration through a feeding tube is not permitted
- Hemoglobin \>= 9 g/dL
- Absolute neutrophil count (ANC) \>= 1,500/mcL
- Platelets \>= 100,000/mcL
- Total bilirubin =\< institutional upper limit of normal (IULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =\< 2.5 x IULN; patients with liver metastases must have AST and ALT =\< 5 x IULN
- Patients must have adequate kidney function as evidenced by at least ONE of the following:
- Serum creatinine (mg/dL) =\< IULN obtained within 14 days prior to registration
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (187)
Providence Hospital
Mobile, Alabama, 36608, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, 99701, United States
The University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, 85704, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, 85724, United States
Fowler Family Center for Cancer Care
Jonesboro, Arkansas, 72401, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Front Range Cancer Specialists
Fort Collins, Colorado, 80528, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
UF Cancer Center at Orlando Health
Orlando, Florida, 32806, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
OnCare Hawaii-Liliha
Honolulu, Hawaii, 96817-3169, United States
Kuakini Medical Center
Honolulu, Hawaii, 96817, United States
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Castle Medical Center
Kailua, Hawaii, 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Oncare Hawaii Inc-Pali Momi
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Cadence Cancer Center at Delnor
Geneva, Illinois, 60134, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Cadence Cancer Center in Warrenville
Warrenville, Illinois, 60555, United States
Franciscan St. Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, 46237, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, 67530, United States
Hays Medical Center
Hays, Kansas, 67601, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
The University of Kansas Cancer Center-West
Kansas City, Kansas, 66112, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, 66210, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, 66762, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
Kansas City Cancer Center-Shawnee Mission
Shawnee Mission, Kansas, 66204, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wichita CCOP
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, 48106, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, 49677, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Kansas City Cancer Center - South
Kansas City, Missouri, 64131, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, 64154, United States
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, 64064, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, 59102, United States
Billings Clinic Cancer Center
Billings, Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623, United States
University of Rochester
Rochester, New York, 14642, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Southeast Cancer Control Consortium CCOP
Winston-Salem, North Carolina, 27104, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, 45220, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus CCOP
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton CCOP
Dayton, Ohio, 45420, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis HealthCare System
Zanesville, Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Baylor Saint Luke's Medical Center
Houston, Texas, 77030, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Michael E DeBakey VA Medical Center
Houston, Texas, 77030, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, 24115, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, 98029, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
EvergreenHealth Medical Center
Kirkland, Washington, 98033, United States
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington, 98034, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Virginia Mason CCOP
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Pacific Medical Center-First Hill
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Group Health Cooperative of Puget Sound Oncology Consortium
Seattle, Washington, 98112, United States
Group Health Cooperative-Seattle
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
United General Hospital
Sedro-Woolley, Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
Rockwood Clinic
Spokane, Washington, 99220, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Related Publications (1)
Ramanathan RK, McDonough SL, Kennecke HF, Iqbal S, Baranda JC, Seery TE, Lim HJ, Hezel AF, Vaccaro GM, Blanke CD. Phase 2 study of MK-2206, an allosteric inhibitor of AKT, as second-line therapy for advanced gastric and gastroesophageal junction cancer: A SWOG cooperative group trial (S1005). Cancer. 2015 Jul 1;121(13):2193-7. doi: 10.1002/cncr.29363. Epub 2015 Mar 30.
PMID: 25827820DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- SWOG Statistical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Ramesh Ramanathan
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2010
First Posted
December 15, 2010
Study Start
January 1, 2011
Primary Completion
May 1, 2014
Study Completion
July 1, 2015
Last Updated
January 18, 2016
Results First Posted
August 4, 2014
Record last verified: 2015-11