ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 50 for:    MK-2206

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01260701
Recruitment Status : Completed
First Posted : December 15, 2010
Results First Posted : August 4, 2014
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Gastroesophageal Junction
Diffuse Gastric Adenocarcinoma
Gastric Intestinal Type Adenocarcinoma
Gastric Mixed Adenocarcinoma
Recurrent Gastric Carcinoma
Intervention Drug: Akt Inhibitor MK2206
Enrollment 75

Recruitment Details  
Pre-assignment Details  
Arm/Group Title MK-2206
Hide Arm/Group Description Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 75
Eligible 71
Eligible and Began Protocol Therapy 70
Completed 0
Not Completed 75
Reason Not Completed
Adverse Event             9
Withdrawal by Subject             2
Progression             53
Death             2
Not protocol specified             3
Under review             1
Ineligible             4
Did not begin protocol therapy             1
Arm/Group Title MK-2206
Hide Arm/Group Description Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Baseline Participants 70
Hide Baseline Analysis Population Description
Eligible patients who began protocol therapy.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 70 participants
60
(30 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Female
21
  30.0%
Male
49
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants
Hispanic or Latino
13
  18.6%
Not Hispanic or Latino
56
  80.0%
Unknown or Not Reported
1
   1.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 70 participants
White 62
Asian 5
Unknown 3
1.Primary Outcome
Title Overall Survival (OS)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy.
Arm/Group Title MK-2206
Hide Arm/Group Description:
Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 70
Median (95% Confidence Interval)
Unit of Measure: months
5
(4 to 9)
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy
Arm/Group Title MK-2206
Hide Arm/Group Description:
Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 70
Median (95% Confidence Interval)
Unit of Measure: months
1.8
(1.7 to 1.8)
3.Secondary Outcome
Title Response Rate (Complete and Partial, Confirmed and Unconfirmed)
Hide Description 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.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who began protocol therapy and were assessed for response.
Arm/Group Title MK-2206
Hide Arm/Group Description:
Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 68
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.5
(0 to 7.9)
4.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for adverse events are included in this summary.
Arm/Group Title MK-2206
Hide Arm/Group Description:
Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 70
Measure Type: Number
Unit of Measure: Participants
Adult respiratory distress syndrome 1
Alanine aminotransferase increased 1
Alkaline phosphatase increased 2
Allergic reaction 1
Anemia 3
Anorexia 3
Aspartate aminotransferase increased 1
Blood and lymphatic system disorders - Other 1
Blood bilirubin increased 1
Cardiac arrest 1
Dehydration 1
Dyspnea 1
Fatigue 4
Gastric hemorrhage 1
Gastroesophageal reflux disease 1
Hyperglycemia 2
Hypokalemia 1
Hyponatremia 2
Hypoxia 1
Lung infection 1
Lymphocyte count decreased 1
Nausea 1
Non-cardiac chest pain 1
Pleural effusion 2
Pneumonitis 1
Pruritus 1
Rash acneiform 2
Rash maculo-papular 2
Respiratory failure 1
Sinus bradycardia 1
Sinus tachycardia 1
Stroke 1
Upper gastrointestinal hemorrhage 1
Vomiting 2
Time Frame Up to 2 years
Adverse Event Reporting Description Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.
 
Arm/Group Title MK-2206
Hide Arm/Group Description Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
All-Cause Mortality
MK-2206
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MK-2206
Affected / at Risk (%)
Total   31/70 (44.29%) 
Blood and lymphatic system disorders   
Anemia   4/70 (5.71%) 
Cardiac disorders   
Cardiac arrest   1/70 (1.43%) 
Sinus tachycardia   2/70 (2.86%) 
Gastrointestinal disorders   
Abdominal distension   1/70 (1.43%) 
Abdominal pain   2/70 (2.86%) 
Colonic obstruction   1/70 (1.43%) 
Constipation   1/70 (1.43%) 
Dysphagia   2/70 (2.86%) 
Esophageal hemorrhage   1/70 (1.43%) 
Gastric hemorrhage   2/70 (2.86%) 
Nausea   5/70 (7.14%) 
Obstruction gastric   1/70 (1.43%) 
Rectal hemorrhage   1/70 (1.43%) 
Small intestinal obstruction   3/70 (4.29%) 
Upper gastrointestinal hemorrhage   1/70 (1.43%) 
Vomiting   3/70 (4.29%) 
General disorders   
Fatigue   1/70 (1.43%) 
Non-cardiac chest pain   1/70 (1.43%) 
Hepatobiliary disorders   
Cholecystitis   1/70 (1.43%) 
Infections and infestations   
Lung infection   2/70 (2.86%) 
Peritoneal infection   1/70 (1.43%) 
Sepsis   1/70 (1.43%) 
Urinary tract infection   1/70 (1.43%) 
Investigations   
Blood bilirubin increased   1/70 (1.43%) 
Creatinine increased   1/70 (1.43%) 
Metabolism and nutrition disorders   
Anorexia   3/70 (4.29%) 
Dehydration   1/70 (1.43%) 
Hyperglycemia   1/70 (1.43%) 
Hypoalbuminemia   1/70 (1.43%) 
Hypokalemia   2/70 (2.86%) 
Musculoskeletal and connective tissue disorders   
Back pain   1/70 (1.43%) 
Chest wall pain   1/70 (1.43%) 
Generalized muscle weakness   1/70 (1.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified - Other   9/70 (12.86%) 
Nervous system disorders   
Stroke   1/70 (1.43%) 
Renal and urinary disorders   
Acute kidney injury   2/70 (2.86%) 
Respiratory, thoracic and mediastinal disorders   
Adult respiratory distress syndrome   1/70 (1.43%) 
Aspiration   2/70 (2.86%) 
Cough   1/70 (1.43%) 
Dyspnea   4/70 (5.71%) 
Pleural effusion   4/70 (5.71%) 
Pneumonitis   2/70 (2.86%) 
Respiratory failure   1/70 (1.43%) 
Skin and subcutaneous tissue disorders   
Pruritus   1/70 (1.43%) 
Rash acneiform   1/70 (1.43%) 
Vascular disorders   
Thromboembolic event   2/70 (2.86%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MK-2206
Affected / at Risk (%)
Total   67/70 (95.71%) 
Blood and lymphatic system disorders   
Anemia   22/70 (31.43%) 
Cardiac disorders   
Sinus bradycardia   4/70 (5.71%) 
Gastrointestinal disorders   
Abdominal distension   4/70 (5.71%) 
Abdominal pain   27/70 (38.57%) 
Constipation   16/70 (22.86%) 
Diarrhea   22/70 (31.43%) 
Dyspepsia   7/70 (10.00%) 
Dysphagia   10/70 (14.29%) 
Gastroesophageal reflux disease   8/70 (11.43%) 
Mucositis oral   7/70 (10.00%) 
Nausea   32/70 (45.71%) 
Vomiting   19/70 (27.14%) 
General disorders   
Edema limbs   4/70 (5.71%) 
Fatigue   48/70 (68.57%) 
Fever   4/70 (5.71%) 
Pain   6/70 (8.57%) 
Investigations   
Alanine aminotransferase increased   8/70 (11.43%) 
Alkaline phosphatase increased   21/70 (30.00%) 
Aspartate aminotransferase increased   11/70 (15.71%) 
Blood bilirubin increased   4/70 (5.71%) 
Creatinine increased   7/70 (10.00%) 
Electrocardiogram QT corrected interval prolonged   8/70 (11.43%) 
Lymphocyte count decreased   14/70 (20.00%) 
Platelet count decreased   4/70 (5.71%) 
Weight loss   18/70 (25.71%) 
White blood cell decreased   7/70 (10.00%) 
Metabolism and nutrition disorders   
Anorexia   27/70 (38.57%) 
Dehydration   4/70 (5.71%) 
Hyperglycemia   28/70 (40.00%) 
Hypoalbuminemia   12/70 (17.14%) 
Hypocalcemia   7/70 (10.00%) 
Hypokalemia   6/70 (8.57%) 
Hyponatremia   16/70 (22.86%) 
Musculoskeletal and connective tissue disorders   
Back pain   10/70 (14.29%) 
Myalgia   5/70 (7.14%) 
Pain in extremity   5/70 (7.14%) 
Nervous system disorders   
Dizziness   6/70 (8.57%) 
Headache   7/70 (10.00%) 
Peripheral sensory neuropathy   9/70 (12.86%) 
Psychiatric disorders   
Anxiety   8/70 (11.43%) 
Depression   4/70 (5.71%) 
Insomnia   7/70 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough   6/70 (8.57%) 
Dyspnea   6/70 (8.57%) 
Skin and subcutaneous tissue disorders   
Dry skin   13/70 (18.57%) 
Pruritus   16/70 (22.86%) 
Rash acneiform   7/70 (10.00%) 
Rash maculo-papular   22/70 (31.43%) 
Skin and subcutaneous tissue disorders - Other   5/70 (7.14%) 
Vascular disorders   
Hypertension   9/70 (12.86%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Study Statistician
Organization: SWOG Statistical Center
Phone: 206-667-4623
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01260701     History of Changes
Other Study ID Numbers: NCI-2011-02619
NCI-2011-02619 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S1005
S1005
CDR0000689602
S1005 ( Other Identifier: SWOG )
S1005 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2010
First Posted: December 15, 2010
Results First Submitted: July 7, 2014
Results First Posted: August 4, 2014
Last Update Posted: January 18, 2016