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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 MedicineHouston, Texas  77030
University of Washington Medical CenterSeattle, Washington  98195-6043
Hurley Medical CenterFlint, Michigan  48503
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Loyola University Medical CenterMaywood, Illinois  60153
Akron General Medical CenterAkron, Ohio  44302
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Via Christi Regional Medical CenterWichita, Kansas  67214
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Winthrop University HospitalMineola, New York  11501
Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109
Cancer Center of Kansas - ChanuteChanute, Kansas  66720
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - NewtonNewton, Kansas  67114
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Munson Medical CenterTraverse City, Michigan  49684
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Regional Medical CenterKalispell, Montana  59901
Adena Regional Medical CenterChillicothe, Ohio  54601
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Harborview Medical CenterSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Good Samaritan Hospital - CincinnatiCincinnati, Ohio  45220
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Poudre Valley HospitalFort Collins, Colorado  80524
Salina Regional Health CenterSalina, Kansas  67401
Mecosta County Medical CenterBig Rapids, Michigan  49307
Iredell Memorial HospitalStatesville, North Carolina  28677
Grandview HospitalDayton, Ohio  45405
Danville Regional Medical CenterDanville, Virginia  24541
Saint Joseph Mercy HospitalAnn Arbor, Michigan  48106
Randolph HospitalAsheboro, North Carolina  27203
Miami Valley HospitalDayton, Ohio  45409
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Mary Rutan HospitalBellefontaine, Ohio  43311
Wayne HospitalGreenville, Ohio  45331
Knox Community HospitalMount Vernon, Ohio  43050
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Rocky Mountain OncologyCasper, Wyoming  82609
Ben Taub General HospitalHouston, Texas  77030
Greene Memorial HospitalXenia, Ohio  45385
Presbyterian HospitalCharlotte, North Carolina  28233-3549
McLeod Regional Medical CenterFlorence, South Carolina  29501
Queen's Medical CenterHonolulu, Hawaii  96813
Providence HospitalMobile, Alabama  36608
Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Saint Louis University HospitalSt. Louis, Missouri  63110-0250
University of RochesterRochester, New York  14642
Cascade Cancer CenterKirkland, Washington  98034-3013
Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
University of Arizona Health Sciences CenterTucson, Arizona  85724
Straub Clinic and HospitalHonolulu, Hawaii  96813
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Columbus CCOPColumbus, Ohio  43206
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Virginia Mason CCOPSeattle, Washington  98101
Oregon Health and Science UniversityPortland, Oregon  97201
Montana Cancer SpecialistsMissoula, Montana  59807-7877
Memorial Health University Medical CenterSavannah, Georgia  31404
University of Southern CaliforniaLos Angeles, California  90033
Rockwood ClinicSpokane, Washington  99220
University of CincinnatiCincinnati, Ohio  45267-0502
Castle Medical CenterKailua, Hawaii  96734
Hays Medical CenterHays, Kansas  67601
Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
Oncare Hawaii Inc-POB IIHonolulu, Hawaii  96813
Oncare Hawaii Inc-KuakiniHonolulu, Hawaii  96817
University of HawaiiHonolulu, Hawaii  96813
Saint Francis Hospital and Health CentersBeech Grove, Indiana  46107
Reid Hospital and Health Care ServicesRichmond, Indiana  47374
Cancer Center of Kansas-KingmanKingman, Kansas  67068
Cancer Center of Kansas - ParsonsParsons, Kansas  67357
Cancer Center of Kansas - PrattPratt, Kansas  67124
Saint Francis Hospital and Medical Center - TopekaTopeka, Kansas  66606
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Michigan Cancer Research Consortium Community Clinical Oncology ProgramAnn Arbor, Michigan  48106
Oakwood HospitalDearborn, Michigan  48123
Saint John Hospital and Medical CenterDetroit, Michigan  48236
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Allegiance HealthJackson, Michigan  49201
Sparrow HospitalLansing, Michigan  48912
Saint Mary Mercy HospitalLivonia, Michigan  48154
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Saint Joseph Mercy OaklandPontiac, Michigan  48341-2985
Saint Joseph Mercy Port HuronPort Huron, Michigan  48060
Saint Mary's of MichiganSaginaw, Michigan  48601
Saint John Macomb-Oakland HospitalWarren, Michigan  48093
Truman Medical CenterKansas City, Missouri  64108
Ozark Health Ventures LLC dba Cancer Research for The Ozarks SpringfieldSpringfield, Missouri  65802
Saint John's HospitalSpringfield, Missouri  65804
Cox Medical CenterSpringfield, Missouri  65807
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
Interlakes Foundation Inc-RochesterRochester, New York  14623
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Doctors HospitalColumbus, Ohio  43228
Grant Medical CenterColumbus, Ohio  43215
Mount Carmel Health Center WestColumbus, Ohio  43222
Good Samaritan Hospital - DaytonDayton, Ohio  45406
Dayton CCOPDayton, Ohio  45429
Samaritan North Health CenterDayton, Ohio  45415
Blanchard Valley HospitalFindlay, Ohio  45840
Atrium Medical Center-Middletown Regional HospitalFranklin, Ohio  45005-1066
Kettering Medical CenterKettering, Ohio  45429
Marietta Memorial HospitalMarietta, Ohio  45750
Upper Valley Medical CenterTroy, Ohio  45373
Saint Ann's HospitalWesterville, Ohio  43081
Genesis HealthCare SystemZanesville, Ohio  43701
Veterans Administration Medical CenterHouston, Texas  77030
Saint Luke's Episcopal HospitalHouston, Texas  77030
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Evergreen Hospital Medical CenterKirkland, Washington  98033
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
University of California Medical Center At Irvine-Orange CampusOrange, California  92868
Kansas City Cancer Centers - NorthKansas City, Missouri  64154
Delnor Community HospitalGeneva, Illinois  60134
Cancer Center of Kansas-LiberalLiberal, Kansas  67901
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Kansas City Cancer Centers-SouthwestOverland Park, Kansas  66210
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Kuakini Medical CenterHonolulu, Hawaii  96817
Arizona Cancer Center at UMC Orange GroveTucson, Arizona  85704
Wilcox Memorial Hospital and Kauai Medical ClinicLihue, Hawaii  96766-1099
Central DuPage Hospital Cancer CenterWarrenville, Illinois  60555
Kansas City Cancer Center-WestKansas City, Kansas  66112
Kansas City Cancer Center-Shawnee MissionShawnee Mission, Kansas  66204
Spectrum Health Reed City HospitalReed City, Michigan  49677
Kansas City Cancer Center - SouthKansas City, Missouri  64131
Kansas City Cancer Center-Lee's SummitLee's Summit, Missouri  64064
Saint John's Clinic-Rolla-Cancer and HematologyRolla, Missouri  65401
Southern Ohio Medical CenterPortsmouth, Ohio  45662
Memorial Hospital Of MartinsvilleMartinsville, Virginia  24115
Cancer Care Center at Island HospitalAnacortes, Washington  98221
Highline Medical Center-Main CampusBurien, Washington  98166
Pacific Medical Center-First HillSeattle, Washington  98104
United General HospitalSedro-Woolley, Washington  98284
Fairbanks Memorial HospitalFairbanks, Alaska  99701
Swedish Cancer Institute-IssaquahIssaquah, Washington  98029
Cone Health Cancer CenterGreensboro, North Carolina  
Franciscan St. Francis HealthIndianapolis, Indiana  46237
Southwest Oncology GroupSan Antonio, Texas  78245
Genesys Regional Medical Center-West Flint CampusFlint, Michigan  48532
Via Christi Hospital-PittsburgPittsburg, Kansas  66762
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Bronson Battle CreekBattle Creek, Michigan  49017
Springfield Regional Medical CenterSpringfield, Ohio  45505
NEA Baptist Memorial HospitalJonesboro, Arkansas  72401
Promise Regional Medical Center-HutchinsonHutchinson, Kansas  65702
Harrison Poulsbo Hematology and OncologyPoulsbo, Washington  98370
NEA Baptist Clinic-MatthewsJonesboro, Arkansas  72401
OnCare Hawaii-LilihaHonolulu, Hawaii  96817-3169
Saint Rose Ambulatory and Surgery CenterGreat Bend, Kansas  67530
Oncare Hawaii Inc - Kapiolani Medical Center at Pali MomiAiea, Hawaii  96701