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

Primary Purpose

Adenocarcinoma of the Gastroesophageal Junction, Diffuse Gastric Adenocarcinoma, Gastric Intestinal Type Adenocarcinoma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Akt Inhibitor MK2206

About this trial

This is an interventional treatment trial for Adenocarcinoma of the Gastroesophageal Junction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (CLOSED TO ACCRUAL 05/01/13)

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Survival (OS)

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

Progression Free Survival (PFS)

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)

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.

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

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.

Full Information

NCT ID

NCT01260701

First Posted

December 14, 2010

Last Updated

December 14, 2015

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01260701

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenocarcinoma of the Gastroesophageal Junction, Diffuse Gastric Adenocarcinoma, Gastric Intestinal Type Adenocarcinoma, Gastric Mixed Adenocarcinoma, Recurrent Gastric Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (CLOSED TO ACCRUAL 05/01/13)

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Akt Inhibitor MK2206

Other Intervention Name(s)

MK2206

Intervention Description

Given PO

Primary Outcome Measure Information:

Title

Overall Survival (OS)

Description

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.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Up to 2 years

Title

Response Rate (Complete and Partial, Confirmed and Unconfirmed)

Description

Time Frame

Up to 2 years

Title

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

Description

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.

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ramesh Ramanathan

Organizational Affiliation

SWOG Cancer Research Network

Official's Role

Principal Investigator

Facility Information:

Facility Name

Providence Hospital

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

Fairbanks Memorial Hospital

City

Fairbanks

State/Province

Alaska

ZIP/Postal Code

99701

Country

United States

Facility Name

The University of Arizona Cancer Center-Orange Grove Campus

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

The University of Arizona Cancer Center-North Campus

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Name

The University of Arizona Medical Center-University Campus

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Fowler Family Center for Cancer Care

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

NEA Baptist Memorial Hospital

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

USC / Norris Comprehensive Cancer Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

UC Irvine Health/Chao Family Comprehensive Cancer Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Poudre Valley Hospital

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80524

Country

United States

Facility Name

Front Range Cancer Specialists

City

Fort Collins

State/Province

Colorado

ZIP/Postal Code

80528

Country

United States

Facility Name

Saint Francis Hospital and Medical Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

Facility Name

UF Cancer Center at Orlando Health

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Memorial University Medical Center

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31404

Country

United States

Facility Name

Oncare Hawaii Inc-Pali Momi

City

Aiea

State/Province

Hawaii

ZIP/Postal Code

96701

Country

United States

Facility Name

Pali Momi Medical Center

City

Aiea

State/Province

Hawaii

ZIP/Postal Code

96701

Country

United States

Facility Name

Oncare Hawaii Inc-POB II

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Queen's Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Straub Clinic and Hospital

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

University of Hawaii Cancer Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

OnCare Hawaii-Liliha

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817-3169

Country

United States

Facility Name

Kuakini Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

Oncare Hawaii Inc-Kuakini

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96817

Country

United States

Facility Name

Kapiolani Medical Center for Women and Children

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96826

Country

United States

Facility Name

Castle Medical Center

City

Kailua

State/Province

Hawaii

ZIP/Postal Code

96734

Country

United States

Facility Name

Wilcox Memorial Hospital and Kauai Medical Clinic

City

Lihue

State/Province

Hawaii

ZIP/Postal Code

96766

Country

United States

Facility Name

Saint Alphonsus Cancer Care Center-Boise

City

Boise

State/Province

Idaho

ZIP/Postal Code

83706

Country

United States

Facility Name

Cadence Cancer Center at Delnor

City

Geneva

State/Province

Illinois

ZIP/Postal Code

60134

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Cadence Cancer Center in Warrenville

City

Warrenville

State/Province

Illinois

ZIP/Postal Code

60555

Country

United States

Facility Name

Franciscan St. Francis Health-Beech Grove

City

Beech Grove

State/Province

Indiana

ZIP/Postal Code

46107

Country

United States

Facility Name

Franciscan Saint Francis Health-Indianapolis

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Reid Hospital and Health Care Services

City

Richmond

State/Province

Indiana

ZIP/Postal Code

47374

Country

United States

Facility Name

Cancer Center of Kansas - Chanute

City

Chanute

State/Province

Kansas

ZIP/Postal Code

66720

Country

United States

Facility Name

Cancer Center of Kansas - Dodge City

City

Dodge City

State/Province

Kansas

ZIP/Postal Code

67801

Country

United States

Facility Name

Cancer Center of Kansas - Fort Scott

City

Fort Scott

State/Province

Kansas

ZIP/Postal Code

66701

Country

United States

Facility Name

Saint Rose Ambulatory and Surgery Center

City

Great Bend

State/Province

Kansas

ZIP/Postal Code

67530

Country

United States

Facility Name

Hays Medical Center

City

Hays

State/Province

Kansas

ZIP/Postal Code

67601

Country

United States

Facility Name

Hutchinson Regional Medical Center

City

Hutchinson

State/Province

Kansas

ZIP/Postal Code

67502

Country

United States

Facility Name

Cancer Center of Kansas-Independence

City

Independence

State/Province

Kansas

ZIP/Postal Code

67301

Country

United States

Facility Name

The University of Kansas Cancer Center-West

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66112

Country

United States

Facility Name

University of Kansas Cancer Center

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

Cancer Center of Kansas-Kingman

City

Kingman

State/Province

Kansas

ZIP/Postal Code

67068

Country

United States

Facility Name

Lawrence Memorial Hospital

City

Lawrence

State/Province

Kansas

ZIP/Postal Code

66044

Country

United States

Facility Name

Cancer Center of Kansas-Liberal

City

Liberal

State/Province

Kansas

ZIP/Postal Code

67901

Country

United States

Facility Name

Cancer Center of Kansas - Newton

City

Newton

State/Province

Kansas

ZIP/Postal Code

67114

Country

United States

Facility Name

Kansas City Cancer Centers-Southwest

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Cancer Center of Kansas - Parsons

City

Parsons

State/Province

Kansas

ZIP/Postal Code

67357

Country

United States

Facility Name

Via Christi Hospital-Pittsburg

City

Pittsburg

State/Province

Kansas

ZIP/Postal Code

66762

Country

United States

Facility Name

Cancer Center of Kansas - Pratt

City

Pratt

State/Province

Kansas

ZIP/Postal Code

67124

Country

United States

Facility Name

Cancer Center of Kansas - Salina

City

Salina

State/Province

Kansas

ZIP/Postal Code

67401

Country

United States

Facility Name

Salina Regional Health Center

City

Salina

State/Province

Kansas

ZIP/Postal Code

67401

Country

United States

Facility Name

Kansas City Cancer Center-Shawnee Mission

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66204

Country

United States

Facility Name

Saint Francis Hospital and Medical Center - Topeka

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Cancer Center of Kansas - Wellington

City

Wellington

State/Province

Kansas

ZIP/Postal Code

67152

Country

United States

Facility Name

Associates In Womens Health

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Cancer Center of Kansas-Wichita Medical Arts Tower

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

Cancer Center of Kansas - Main Office

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Via Christi Regional Medical Center

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Wichita CCOP

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Cancer Center of Kansas - Winfield

City

Winfield

State/Province

Kansas

ZIP/Postal Code

67156

Country

United States

Facility Name

Sinai Hospital of Baltimore

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21215

Country

United States

Facility Name

Saint Joseph Mercy Hospital

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106-0995

Country

United States

Facility Name

Michigan Cancer Research Consortium CCOP

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Bronson Battle Creek

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49017

Country

United States

Facility Name

Spectrum Health Big Rapids Hospital

City

Big Rapids

State/Province

Michigan

ZIP/Postal Code

49307

Country

United States

Facility Name

Oakwood Hospital and Medical Center

City

Dearborn

State/Province

Michigan

ZIP/Postal Code

48124

Country

United States

Facility Name

Saint John Hospital and Medical Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

Facility Name

Hurley Medical Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48502

Country

United States

Facility Name

Genesys Hurley Cancer Institute

City

Flint

State/Province

Michigan

ZIP/Postal Code

48503

Country

United States

Facility Name

Genesys Regional Medical Center-West Flint Campus

City

Flint

State/Province

Michigan

ZIP/Postal Code

48532

Country

United States

Facility Name

Grand Rapids Clinical Oncology Program

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Mercy Health Saint Mary's

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Spectrum Health at Butterworth Campus

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Allegiance Health

City

Jackson

State/Province

Michigan

ZIP/Postal Code

49201

Country

United States

Facility Name

Sparrow Hospital

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48912

Country

United States

Facility Name

Saint Mary Mercy Hospital

City

Livonia

State/Province

Michigan

ZIP/Postal Code

48154

Country

United States

Facility Name

Mercy Health Mercy Campus

City

Muskegon

State/Province

Michigan

ZIP/Postal Code

49444

Country

United States

Facility Name

Saint Joseph Mercy Oakland

City

Pontiac

State/Province

Michigan

ZIP/Postal Code

48341

Country

United States

Facility Name

Saint Joseph Mercy Port Huron

City

Port Huron

State/Province

Michigan

ZIP/Postal Code

48060

Country

United States

Facility Name

Spectrum Health Reed City Hospital

City

Reed City

State/Province

Michigan

ZIP/Postal Code

49677

Country

United States

Facility Name

Saint Mary's of Michigan

City

Saginaw

State/Province

Michigan

ZIP/Postal Code

48601

Country

United States

Facility Name

Munson Medical Center

City

Traverse City

State/Province

Michigan

ZIP/Postal Code

49684

Country

United States

Facility Name

Saint John Macomb-Oakland Hospital

City

Warren

State/Province

Michigan

ZIP/Postal Code

48093

Country

United States

Facility Name

Metro Health Hospital

City

Wyoming

State/Province

Michigan

ZIP/Postal Code

49519

Country

United States

Facility Name

Truman Medical Center

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

Kansas City Cancer Center - South

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64131

Country

United States

Facility Name

Kansas City Cancer Centers - North

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64154

Country

United States

Facility Name

Kansas City Cancer Center-Lee's Summit

City

Lee's Summit

State/Province

Missouri

ZIP/Postal Code

64064

Country

United States

Facility Name

Saint John's Clinic-Rolla-Cancer and Hematology

City

Rolla

State/Province

Missouri

ZIP/Postal Code

65401

Country

United States

Facility Name

Saint Louis University Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Cancer Research for the Ozarks NCORP

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65804

Country

United States

Facility Name

Mercy Hospital Springfield

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65804

Country

United States

Facility Name

CoxHealth South Hospital

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Montana Cancer Consortium NCORP

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Saint Vincent Healthcare

City

Billings

State/Province

Montana

ZIP/Postal Code

59101

Country

United States

Facility Name

Frontier Cancer Center and Blood Institute-Billings

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

Billings Clinic Cancer Center

City

Billings

State/Province

Montana

ZIP/Postal Code

59107

Country

United States

Facility Name

Bozeman Deaconess Cancer Center

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59715

Country

United States

Facility Name

Bozeman Deaconess Hospital

City

Bozeman

State/Province

Montana

ZIP/Postal Code

59715

Country

United States

Facility Name

Saint James Community Hospital and Cancer Treatment Center

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Benefis Healthcare- Sletten Cancer Institute

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Facility Name

Great Falls Clinic

City

Great Falls

State/Province

Montana

ZIP/Postal Code

59405

Country

United States

Facility Name

Saint Peter's Community Hospital

City

Helena

State/Province

Montana

ZIP/Postal Code

59601

Country

United States

Facility Name

Glacier Oncology PLLC

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

Kalispell Regional Medical Center

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

Montana Cancer Specialists

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

Saint Patrick Hospital - Community Hospital

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

Winthrop University Hospital

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

Interlakes Foundation Inc-Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14623

Country

United States

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Randolph Hospital

City

Asheboro

State/Province

North Carolina

ZIP/Postal Code

27203

Country

United States

Facility Name

Novant Health Presbyterian Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Wayne Memorial Hospital

City

Goldsboro

State/Province

North Carolina

ZIP/Postal Code

27534

Country

United States

Facility Name

Cone Health Cancer Center

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

Iredell Memorial Hospital

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28677

Country

United States

Facility Name

Southeast Cancer Control Consortium CCOP

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Akron General Medical Center

City

Akron

State/Province

Ohio

ZIP/Postal Code

44307

Country

United States

Facility Name

Mary Rutan Hospital

City

Bellefontaine

State/Province

Ohio

ZIP/Postal Code

43311

Country

United States

Facility Name

Adena Regional Medical Center

City

Chillicothe

State/Province

Ohio

ZIP/Postal Code

45601

Country

United States

Facility Name

Good Samaritan Hospital - Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45220

Country

United States

Facility Name

University of Cincinnati

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Riverside Methodist Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43214

Country

United States

Facility Name

Columbus CCOP

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Grant Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Mount Carmel Health Center West

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43222

Country

United States

Facility Name

Doctors Hospital

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43228

Country

United States

Facility Name

Grandview Hospital

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45405

Country

United States

Facility Name

Good Samaritan Hospital - Dayton

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

Miami Valley Hospital

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Samaritan North Health Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45415

Country

United States

Facility Name

Dayton CCOP

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45420

Country

United States

Facility Name

Grady Memorial Hospital

City

Delaware

State/Province

Ohio

ZIP/Postal Code

43015

Country

United States

Facility Name

Blanchard Valley Hospital

City

Findlay

State/Province

Ohio

ZIP/Postal Code

45840

Country

United States

Facility Name

Atrium Medical Center-Middletown Regional Hospital

City

Franklin

State/Province

Ohio

ZIP/Postal Code

45005-1066

Country

United States

Facility Name

Wayne Hospital

City

Greenville

State/Province

Ohio

ZIP/Postal Code

45331

Country

United States

Facility Name

Kettering Medical Center

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

Fairfield Medical Center

City

Lancaster

State/Province

Ohio

ZIP/Postal Code

43130

Country

United States

Facility Name

Marietta Memorial Hospital

City

Marietta

State/Province

Ohio

ZIP/Postal Code

45750

Country

United States

Facility Name

Knox Community Hospital

City

Mount Vernon

State/Province

Ohio

ZIP/Postal Code

43050

Country

United States

Facility Name

Licking Memorial Hospital

City

Newark

State/Province

Ohio

ZIP/Postal Code

43055

Country

United States

Facility Name

Southern Ohio Medical Center

City

Portsmouth

State/Province

Ohio

ZIP/Postal Code

45662

Country

United States

Facility Name

Springfield Regional Medical Center

City

Springfield

State/Province

Ohio

ZIP/Postal Code

45505

Country

United States

Facility Name

Upper Valley Medical Center

City

Troy

State/Province

Ohio

ZIP/Postal Code

45373

Country

United States

Facility Name

Saint Ann's Hospital

City

Westerville

State/Province

Ohio

ZIP/Postal Code

43081

Country

United States

Facility Name

Clinton Memorial Hospital

City

Wilmington

State/Province

Ohio

ZIP/Postal Code

45177

Country

United States

Facility Name

Greene Memorial Hospital

City

Xenia

State/Province

Ohio

ZIP/Postal Code

45385

Country

United States

Facility Name

Genesis HealthCare System

City

Zanesville

State/Province

Ohio

ZIP/Postal Code

43701

Country

United States

Facility Name

University of Oklahoma Health Sciences Center

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

McLeod Regional Medical Center

City

Florence

State/Province

South Carolina

ZIP/Postal Code

29506

Country

United States

Facility Name

University of Tennessee - Knoxville

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37920

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Baylor Saint Luke's Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Ben Taub General Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Michael E DeBakey VA Medical Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Danville Regional Medical Center

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

Memorial Hospital Of Martinsville

City

Martinsville

State/Province

Virginia

ZIP/Postal Code

24115

Country

United States

Facility Name

Cancer Care Center at Island Hospital

City

Anacortes

State/Province

Washington

ZIP/Postal Code

98221

Country

United States

Facility Name

PeaceHealth Saint Joseph Medical Center

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Harrison HealthPartners Hematology and Oncology-Bremerton

City

Bremerton

State/Province

Washington

ZIP/Postal Code

98310

Country

United States

Facility Name

Highline Medical Center-Main Campus

City

Burien

State/Province

Washington

ZIP/Postal Code

98166

Country

United States

Facility Name

Swedish Cancer Institute-Issaquah

City

Issaquah

State/Province

Washington

ZIP/Postal Code

98029

Country

United States

Facility Name

Kadlec Clinic Hematology and Oncology

City

Kennewick

State/Province

Washington

ZIP/Postal Code

99336

Country

United States

Facility Name

EvergreenHealth Medical Center

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98033

Country

United States

Facility Name

Seattle Cancer Care Alliance at EvergreenHealth

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Skagit Valley Hospital

City

Mount Vernon

State/Province

Washington

ZIP/Postal Code

98274

Country

United States

Facility Name

Harrison HealthPartners Hematology and Oncology-Poulsbo

City

Poulsbo

State/Province

Washington

ZIP/Postal Code

98370

Country

United States

Facility Name

Virginia Mason CCOP

City

Seattle

State/Province

Washington

ZIP/Postal Code

98101

Country

United States

Facility Name

Harborview Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Minor and James Medical PLLC

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Pacific Medical Center-First Hill

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Fred Hutchinson Cancer Research Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

Facility Name

Group Health Cooperative of Puget Sound Oncology Consortium

City

Seattle

State/Province

Washington

ZIP/Postal Code

98112

Country

United States

Facility Name

Group Health Cooperative-Seattle

City

Seattle

State/Province

Washington

ZIP/Postal Code

98112

Country

United States

Facility Name

Swedish Medical Center-First Hill

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122-4307

Country

United States

Facility Name

The Polyclinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

University of Washington Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98195

Country

United States

Facility Name

United General Hospital

City

Sedro-Woolley

State/Province

Washington

ZIP/Postal Code

98284

Country

United States

Facility Name

Cancer Care Northwest - Spokane South

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

Facility Name

Evergreen Hematology and Oncology PS

City

Spokane

State/Province

Washington

ZIP/Postal Code

99218

Country

United States

Facility Name

Rockwood Clinic

City

Spokane

State/Province

Washington

ZIP/Postal Code

99220

Country

United States

Facility Name

Wenatchee Valley Hospital and Clinics

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801

Country

United States

Facility Name

Rocky Mountain Oncology

City

Casper

State/Province

Wyoming

ZIP/Postal Code

82609

Country

United States

Facility Name

Welch Cancer Center

City

Sheridan

State/Province

Wyoming

ZIP/Postal Code

82801

Country

United States

Facility Name

BCCA-Vancouver Cancer Centre

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25827820

Citation

Ramanathan RK, McDonough SL, Kennecke HF, Iqbal S, Baranda JC, Seery TE, Lim HJ, Hezel AF, Vaccaro GM, Blanke CD. Phase 2 study of MK-2206, an allosteric inhibitor of AKT, as second-line therapy for advanced gastric and gastroesophageal junction cancer: A SWOG cooperative group trial (S1005). Cancer. 2015 Jul 1;121(13):2193-7. doi: 10.1002/cncr.29363. Epub 2015 Mar 30.

Results Reference

derived

Learn more about this trial

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

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

Adenocarcinoma of the Gastroesophageal Junction, Diffuse Gastric Adenocarcinoma, Gastric Intestinal Type Adenocarcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial