Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer (S1005)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01260701
First received: December 14, 2010
Last updated: July 7, 2014
Last verified: July 2014
Results First Received: July 7, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Gastroesophageal Junction
Adenocarcinoma of the Stomach
Recurrent Esophageal Cancer
Recurrent Gastric Cancer
Intervention: Drug: Akt inhibitor MK2206

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MK-2206 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.

Participant Flow:   Overall Study
    MK-2206  
STARTED     75  
Eligible     71  
Eligible and Began Protocol Therapy     70  
COMPLETED     0  
NOT COMPLETED     75  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible patients who began protocol therapy.

Reporting Groups
  Description
MK-2206 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.

Baseline Measures
    MK-2206  
Number of Participants  
[units: participants]
  70  
Age  
[units: years]
Median ( Full Range )
  60  
  ( 30 to 87 )  
Gender  
[units: participants]
 
Female     21  
Male     49  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     13  
Not Hispanic or Latino     56  
Unknown or Not Reported     1  
Race/Ethnicity, Customized  
[units: participants]
 
White     62  
Asian     5  
Unknown     3  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Up to 2 years ]

2.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: Up to 2 years ]

3.  Secondary:   Response Rate (Complete and Partial, Confirmed and Unconfirmed)   [ Time Frame: Up to 2 years ]

4.  Secondary:   Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01260701     History of Changes
Other Study ID Numbers: NCI-2011-02619, NCI-2011-02619, SWOG-S1005, CDR0000689602, S1005, S1005, U10CA180888, U10CA032102
Study First Received: December 14, 2010
Results First Received: July 7, 2014
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration