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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
Open (Enrolling)
Adenocarcinoma of the Gastroesophageal Junction, Adenocarcinoma of the Stomach, Recurrent Esophageal Cancer, Recurrent Gastric Cancer

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Trial Information

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


I. To estimate the overall survival (OS) for patients with advanced gastric and
gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206.


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

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

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

- 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

- 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

Type of Study:


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:


Principal Investigator

Ramesh Ramanathan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




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



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Loyola University Medical Center Maywood, Illinois  60153
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Knox Community Hospital Mount Vernon, Ohio  43050
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
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Ben Taub General Hospital Houston, Texas  77030
Greene Memorial Hospital Xenia, Ohio  45385
Presbyterian Hospital Charlotte, North Carolina  28233-3549
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Kapiolani Medical Center at Pali Momi Aiea, Hawaii  96701
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Saint Louis University Hospital St. Louis, Missouri  63110-0250
University of Rochester Rochester, New York  14642
Cascade Cancer Center Kirkland, Washington  98034-3013
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University of Arizona Health Sciences Center Tucson, Arizona  85724
Straub Clinic and Hospital Honolulu, Hawaii  96813
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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
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University of Southern California Los Angeles, California  90033
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M D Anderson Cancer Center- Orlando Orlando, Florida  32806
Oncare Hawaii Inc-POB II Honolulu, Hawaii  96813
Oncare Hawaii Inc-Kuakini Honolulu, Hawaii  96817
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Oakwood Hospital Dearborn, Michigan  48123
Saint John Hospital and Medical Center Detroit, Michigan  48236
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
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Spectrum Health at Butterworth Campus Grand Rapids, Michigan  49503
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Truman Medical Center Kansas City, Missouri  64108
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Saint John's Hospital Springfield, Missouri  65804
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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
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Interlakes Foundation Inc-Rochester Rochester, New York  14623
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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
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Columbia Basin Hematology and Oncology PLLC Kennewick, Washington  99336
Evergreen Hospital Medical Center Kirkland, Washington  98033
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University of Tennessee - Knoxville Knoxville, Tennessee  37920
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