Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer
- Conditions
- Adenocarcinoma of the Gastroesophageal JunctionDiffuse Gastric AdenocarcinomaGastric Intestinal Type AdenocarcinomaRecurrent Gastric CarcinomaGastric Mixed Adenocarcinoma
- Interventions
- Registration Number
- NCT01260701
- Lead Sponsor
- National Cancer Institute (NCI)
- Brief Summary
This phase II clinical trial studies 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.
- 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 (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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
-
Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction that has progressed after first-line treatment, or is recurrent within 6 months after receiving adjuvant therapy; patients must have had exactly one prior systemic treatment regimen; previous adjuvant (chemotherapy [chemo]) radiotherapy is permitted; prior chemotherapy given concurrently with radiation for radiosensitization is not considered one prior systemic regimen
-
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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (CLOSED TO ACCRUAL 05/01/13) Akt Inhibitor MK2206 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.
- Primary Outcome Measures
Name Time Method Overall Survival (OS) Up to 2 years Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
- Secondary Outcome Measures
Name Time Method Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug Up to 2 years Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.
Progression Free Survival (PFS) Up to 2 years PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Response Rate (Complete and Partial, Confirmed and Unconfirmed) Up to 2 years Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to \< 1.0 cm. Partial response (PR) is \>= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Trial Locations
- Locations (187)
The University of Arizona Medical Center-University Campus
🇺🇸Tucson, Arizona, United States
Saint Vincent Healthcare
🇺🇸Billings, Montana, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
🇺🇸Great Falls, Montana, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Virginia Mason CCOP
🇺🇸Seattle, Washington, United States
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
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
Memorial University Medical Center
🇺🇸Savannah, Georgia, United States
Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Oncare Hawaii Inc-Pali Momi
🇺🇸Aiea, Hawaii, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
🇺🇸Lihue, 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
Franciscan St. Francis Health-Beech Grove
🇺🇸Beech Grove, Indiana, United States
Cadence Cancer Center in Warrenville
🇺🇸Warrenville, Illinois, United States
Reid Hospital and Health Care Services
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Hays Medical Center
🇺🇸Hays, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, 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
Associates In Womens Health
🇺🇸Wichita, Kansas, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Wichita CCOP
🇺🇸Wichita, Kansas, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Bronson Battle Creek
🇺🇸Battle Creek, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Spectrum Health Big Rapids Hospital
🇺🇸Big Rapids, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
🇺🇸Flint, Michigan, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Grand Rapids Clinical Oncology Program
🇺🇸Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Saint Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Mercy Health Mercy Campus
🇺🇸Muskegon, Michigan, United States
Spectrum Health Reed City Hospital
🇺🇸Reed City, Michigan, United States
Saint Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Saint Mary's of Michigan
🇺🇸Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital
🇺🇸Warren, Michigan, United States
Saint Joseph Mercy Port Huron
🇺🇸Port Huron, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, 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
Saint Louis University Hospital
🇺🇸Saint Louis, 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
Montana Cancer Consortium NCORP
🇺🇸Billings, Montana, United States
Frontier Cancer Center and Blood Institute-Billings
🇺🇸Billings, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
🇺🇸Butte, 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
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Mary Rutan Hospital
🇺🇸Bellefontaine, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, 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
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
🇺🇸Dayton, Ohio, United States
Dayton CCOP
🇺🇸Dayton, Ohio, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Samaritan North Health Center
🇺🇸Dayton, 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
Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Genesis HealthCare System
🇺🇸Zanesville, Ohio, United States
McLeod Regional Medical Center
🇺🇸Florence, South Carolina, United States
University of Tennessee - Knoxville
🇺🇸Knoxville, Tennessee, United States
Baylor Saint Luke's Medical Center
🇺🇸Houston, Texas, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
PeaceHealth Saint Joseph Medical Center
🇺🇸Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
🇺🇸Bremerton, Washington, United States
Memorial Hospital Of Martinsville
🇺🇸Martinsville, Virginia, United States
Ben Taub General Hospital
🇺🇸Houston, Texas, United States
Michael E DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Swedish Cancer Institute-Issaquah
🇺🇸Issaquah, Washington, United States
Highline Medical Center-Main Campus
🇺🇸Burien, 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
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
The Polyclinic
🇺🇸Seattle, Washington, United States
Group Health Cooperative of Puget Sound Oncology Consortium
🇺🇸Seattle, Washington, United States
Swedish Medical Center-First Hill
🇺🇸Seattle, Washington, United States
Group Health Cooperative-Seattle
🇺🇸Seattle, Washington, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Rockwood Clinic
🇺🇸Spokane, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
United General Hospital
🇺🇸Sedro-Woolley, Washington, United States
Evergreen Hematology and Oncology PS
🇺🇸Spokane, Washington, United States
Wenatchee Valley Hospital and Clinics
🇺🇸Wenatchee, Washington, United States
BCCA-Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Franciscan Saint Francis Health-Indianapolis
🇺🇸Indianapolis, Indiana, United States
Good Samaritan Hospital - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Pali Momi Medical Center
🇺🇸Aiea, Hawaii, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Saint Rose Ambulatory and Surgery Center
🇺🇸Great Bend, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas-Liberal
🇺🇸Liberal, Kansas, United States
Castle Medical Center
🇺🇸Kailua, Hawaii, United States
Kansas City Cancer Center-Shawnee Mission
🇺🇸Shawnee Mission, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
🇺🇸Wichita, 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
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Hutchinson Regional Medical Center
🇺🇸Hutchinson, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas - Main Office
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium CCOP
🇺🇸Ann Arbor, Michigan, United States
Saint John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Southeast Cancer Control Consortium CCOP
🇺🇸Winston-Salem, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
UF Cancer Center at Orlando Health
🇺🇸Orlando, Florida, United States
Oncare Hawaii Inc-POB II
🇺🇸Honolulu, Hawaii, United States
Straub Clinic and Hospital
🇺🇸Honolulu, Hawaii, United States
Oncare Hawaii Inc-Kuakini
🇺🇸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
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, 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
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Cancer Center of Kansas - Pratt
🇺🇸Pratt, Kansas, United States
Welch Cancer Center
🇺🇸Sheridan, Wyoming, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Saint Francis Hospital and Medical Center - Topeka
🇺🇸Topeka, Kansas, United States
Cancer Care Center at Island Hospital
🇺🇸Anacortes, Washington, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States