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A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Gastroesophageal Junction, Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer

Thank you

Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival of patients treated with Akt inhibitor MK2206

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Ramesh Ramanathan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2011-02619

NCT ID:

NCT01260701

Start Date:

January 2011

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Adenocarcinoma of the Stomach
  • Recurrent Esophageal Cancer
  • Recurrent Gastric Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms

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