Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer
NCT ID: NCT01260701
Last Updated: 2016-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
2011-01-31
2015-07-31
Brief Summary
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Detailed Description
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I. To estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206 (Akt inhibitor MK2206).
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 (CLOSED TO ACCRUAL 05/01/13):
Patients receive Akt inhibitor MK2206 orally (PO) every other day on days 1-28. 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (CLOSED TO ACCRUAL 05/01/13)
Patients 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.
Akt Inhibitor MK2206
Given PO
Interventions
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Akt Inhibitor MK2206
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Calculated creatinine clearance \> 50 ml/min; the serum creatinine value used in the calculation must have been obtained within 14 days prior to registration
* Patients must have international normalized ratio (INR) =\< 1.2 unless taking therapeutic doses of warfarin; this result must be obtained within 14 days prior to registration
* Patients must have fasting blood sugar =\< 150 mg/dL within 28 days prior to registration
* Patients must have hemoglobin A1C \< 7% within 28 days prior to registration
* Patients must have an electrocardiogram (ECG) within 28 days prior to registration; patients must have corrected QT interval (QTcF) (by Fridericia's calculation) \< 450 msec (male) or \< 470 msec (female)
* Patients must have a Zubrod performance status of 0-1
* Patient must not have any of the following: a history of congenital long QT syndrome; use of concomitant medications that could prolong the QTc interval; New York Heart Association class III or IV heart failure; history of myocardial infarction within 6 months prior to registration; uncontrolled dysrhythmias; poorly controlled angina; resting heart rate =\< 50 bpm (bradycardia)
* Patients must not be receiving concurrent treatment with drugs that are strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4); patients must be able to safely discontinue treatment with these agents for \>= 2 weeks prior to beginning protocol therapy
* Patient must not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
* Patient must not be pregnant or nursing; women/men of reproductive potential must have agreed to use two forms of contraception for the duration of protocol treatment and for one month after discontinuation of MK-2206; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any time a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
* No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Ramesh Ramanathan
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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Providence Hospital
Mobile, Alabama, United States
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States
The University of Arizona Cancer Center-Orange Grove Campus
Tucson, Arizona, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, United States
The University of Arizona Medical Center-University Campus
Tucson, Arizona, United States
Fowler Family Center for Cancer Care
Jonesboro, Arkansas, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
UF Cancer Center at Orlando Health
Orlando, Florida, United States
Memorial University Medical Center
Savannah, Georgia, United States
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States
Queen's Medical Center
Honolulu, Hawaii, United States
Straub Clinic and Hospital
Honolulu, Hawaii, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, United States
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States
Kuakini Medical Center
Honolulu, Hawaii, United States
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Castle Medical Center
Kailua, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States
Oncare Hawaii Inc-Pali Momi
‘Aiea, Hawaii, United States
Pali Momi Medical Center
‘Aiea, Hawaii, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Cadence Cancer Center at Delnor
Geneva, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Cadence Cancer Center in Warrenville
Warrenville, Illinois, United States
Franciscan St. Francis Health-Beech Grove
Beech Grove, Indiana, United States
Franciscan Saint Francis Health-Indianapolis
Indianapolis, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States
Hays Medical Center
Hays, Kansas, United States
Hutchinson Regional Medical Center
Hutchinson, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
The University of Kansas Cancer Center-West
Kansas City, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Salina Regional Health Center
Salina, Kansas, United States
Kansas City Cancer Center-Shawnee Mission
Shawnee Mission, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita CCOP
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Truman Medical Center
Kansas City, Missouri, United States
Kansas City Cancer Center - South
Kansas City, Missouri, United States
Kansas City Cancer Centers - North
Kansas City, Missouri, United States
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis University Hospital
St Louis, Missouri, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Winthrop University Hospital
Mineola, New York, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, United States
University of Rochester
Rochester, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Southeast Cancer Control Consortium CCOP
Winston-Salem, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
Mary Rutan Hospital
Bellefontaine, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus CCOP
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, 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 CCOP
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, 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
Fairfield Medical Center
Lancaster, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Genesis HealthCare System
Zanesville, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Baylor Saint Luke's Medical Center
Houston, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Michael E DeBakey VA Medical Center
Houston, Texas, United States
Danville Regional Medical Center
Danville, Virginia, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
EvergreenHealth Medical Center
Kirkland, Washington, United States
Seattle Cancer Care Alliance at EvergreenHealth
Kirkland, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
Virginia Mason CCOP
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Pacific Medical Center-First Hill
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Group Health Cooperative of Puget Sound Oncology Consortium
Seattle, Washington, United States
Group Health Cooperative-Seattle
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
The Polyclinic
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
United General Hospital
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, United States
Rockwood Clinic
Spokane, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada
Countries
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References
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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.
Other Identifiers
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NCI-2011-02619
Identifier Type: REGISTRY
Identifier Source: secondary_id
SWOG-S1005
Identifier Type: -
Identifier Source: secondary_id
S1005
Identifier Type: -
Identifier Source: secondary_id
CDR0000689602
Identifier Type: -
Identifier Source: secondary_id
S1005
Identifier Type: OTHER
Identifier Source: secondary_id
S1005
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02619
Identifier Type: -
Identifier Source: org_study_id
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