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Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01260701
First received: December 14, 2010
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

This phase II clinical trial is studying 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.


Condition Intervention Phase
Adenocarcinoma of the Gastroesophageal Junction
Adenocarcinoma of the Stomach
Recurrent Esophageal Cancer
Recurrent Gastric Cancer
Drug: Akt inhibitor MK2206
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival of patients treated with Akt inhibitor MK2206 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival of patients treated with Akt inhibitor MK2206 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Response rate (confirmed and unconfirmed complete and partial response) according to RECIST 1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicity incidents assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 64
Study Start Date: January 2011
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (Akt inhibitor MK2206)
Patients receive Akt inhibitor MK2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Akt inhibitor MK2206
Given PO
Other Name: MK2206

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction

    • Disease that has progressed after first-line regimen or is recurrent within the past 6 months after adjuvant therapy
  • Measurable disease by computed tomography (CT) scans or magnetic resonance imaging (MRI) within the past 28 days
  • No known brain metastases
  • More than 3 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C)
  • No prior PI3, AKT, or Mtor inhibitor for any reason
  • Recovered to =< grade 1 toxicities from prior therapy
  • No concurrent or plan to receive any other investigational agents
  • Able to tolerate oral medications

    • No malabsorption or chronic diarrhea (>= grade 2)
    • No feeding tube
  • Hemoglobin >= 9 g/dL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelet count >= 100,000/mcL
  • Total bilirubin =< institutional upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (IULN) (=< 5.0 times IULN for patients with liver metastases)
  • Serum creatinine =< IULN OR calculated creatinine clearance > 50 mL/min
  • International normalized ratio (INR) =< 1.2 (unless taking therapeutic warfarin)
  • Fasting blood sugar =< 150 mg/dL
  • Hemoglobin A1C < 7%
  • QTcF < 450 msec (male) or QTcF < 470 msec (female)
  • Zubrod performance status 0-1
  • None of the following:

    • History of congenital long QT syndrome
    • New York Heart Association (NYHA) class III or IV heart failure
    • History of myocardial infarction within the past 6 months
    • Uncontrolled dysrhythmia
    • Poorly controlled angina
    • Resting heart rate =< 50 bpm (bradycardia)
  • At least 2 weeks since prior and no concurrent drugs that are strong inducers or inhibitors of CYP3A4
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
  • Patient must not be pregnant or nursing because of the risk of fetal or infant harm; 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
  • More than 5 years since another malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer for which the patient is currently in complete remission
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260701

  Hide Study Locations
Locations
United States, Alabama
Providence Hospital
Mobile, Alabama, United States, 36608
United States, Alaska
Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
United States, Arizona
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, United States, 85704
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, United States, 85719
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Arkansas
NEA Baptist Clinic-Matthews
Jonesboro, Arkansas, United States, 72401
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States, 72401
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
University of Southern California
Los Angeles, California, United States, 90033-0804
University of California Medical Center At Irvine-Orange Campus
Orange, California, United States, 92868
United States, Colorado
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Florida
M D Anderson Cancer Center- Orlando
Orlando, Florida, United States, 32806
United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
Oncare Hawaii Inc - Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Kuakini Medical Center
Honolulu, Hawaii, United States, 96817
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Delnor Community Hospital
Geneva, Illinois, United States, 60134
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Central DuPage Hospital Cancer Center
Warrenville, Illinois, United States, 60555
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Saint Rose Ambulatory and Surgery Center
Great Bend, Kansas, United States, 67530
Hays Medical Center
Hays, Kansas, United States, 67601
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States, 65702
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Kansas City Cancer Center-West
Kansas City, Kansas, United States, 66112
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States, 66210
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Salina Regional Health Center
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Kansas City Cancer Center-Shawnee Mission
Shawnee Mission, Kansas, United States, 66204
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Mecosta County Medical Center
Big Rapids, Michigan, United States, 49307
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Mercy Health Partners-Mercy Campus
Muskegon, Michigan, United States, 49444
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Spectrum Health Reed City Hospital
Reed City, Michigan, United States, 49677
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Munson Medical Center
Traverse City, Michigan, United States, 49684
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Kansas City Cancer Center - South
Kansas City, Missouri, United States, 64131
Kansas City Cancer Centers - North
Kansas City, Missouri, United States, 64154
Kansas City Cancer Center-Lee's Summit
Lee's Summit, Missouri, United States, 64064
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Saint John's Hospital
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65802
Cox Medical Center
Springfield, Missouri, United States, 65807
United States, Montana
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
University of Rochester
Rochester, New York, United States, 14642
Interlakes Foundation Inc-Rochester
Rochester, New York, United States, 14623
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Good Samaritan Hospital - Cincinnati
Cincinnati, Ohio, United States, 45220
Columbus CCOP
Columbus, Ohio, United States, 43215
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Doctors Hospital
Columbus, Ohio, United States, 43228
Grant Medical Center
Columbus, Ohio, United States, 43215
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grandview Hospital
Dayton, Ohio, United States, 45405
Dayton CCOP
Dayton, Ohio, United States, 45420
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Knox Community Hospital
Mount Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29506
United States, Tennessee
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Ben Taub General Hospital
Houston, Texas, United States, 77030
Saint Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Veterans Administration Medical Center
Houston, Texas, United States, 77030
Southwest Oncology Group
San Antonio, Texas, United States, 78245
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Memorial Hospital Of Martinsville
Martinsville, Virginia, United States, 24115
United States, Washington
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison Bremerton Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Cascade Cancer Center
Kirkland, Washington, United States, 98034
Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98033
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Harrison Poulsbo Hematology and Oncology
Poulsbo, Washington, United States, 98370
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Harborview Medical Center
Seattle, Washington, United States, 98104
Pacific Medical Center-First Hill
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Group Health Cooperative
Seattle, Washington, United States, 98112
The Polyclinic
Seattle, Washington, United States, 98122
Virginia Mason CCOP
Seattle, Washington, United States, 98101
University of Washington Medical Center
Seattle, Washington, United States, 98195
United General Hospital
Sedro-Woolley, Washington, United States, 98284
Rockwood Clinic
Spokane, Washington, United States, 99220
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Investigators
Principal Investigator: Ramesh Ramanathan Southwest Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01260701     History of Changes
Other Study ID Numbers: NCI-2011-02619, NCI-2011-02619, SWOG-S1005, CDR0000689602, S1005, S1005, U10CA032102
Study First Received: December 14, 2010
Last Updated: December 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on April 17, 2014