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MK2206 in Treating Patients With Advanced Liver Cancer That Did Not Respond to Previous Therapy

This study has been terminated.
(Early termination for discouraging results)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01239355
First received: November 10, 2010
Last updated: September 3, 2015
Last verified: March 2013
Results First Received: June 10, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Hepatocellular Carcinoma
Advanced Adult Hepatocellular Carcinoma
Localized Non-Resectable Adult Liver Carcinoma
Recurrent Adult Liver Carcinoma
Interventions: Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis

  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
Treatment (Akt Inhibitor MK2206)

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Akt Inhibitor MK2206)  
STARTED     15  
COMPLETED     15  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Treatment (Akt Inhibitor MK2206)

Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies


Baseline Measures
    Treatment (Akt Inhibitor MK2206)  
Number of Participants  
[units: participants]
  15  
Age  
[units: years]
Median (Full Range)
  65  
  (50 to 85)  
Gender  
[units: participants]
 
Female     3  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     15  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: Until disease progression or death, up to 26 months ]

2.  Secondary:   Objective Response   [ Time Frame: Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months ]

3.  Secondary:   Overall Survival   [ Time Frame: Until death, up to 26 months ]


  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
Study was terminated early after the first stage of a two-stage design, allowing for early termination for discouraging results


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01239355     History of Changes
Other Study ID Numbers: NCI-2011-02549
NCI-2011-02549 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000688549
CHNMC-PHII-105
PHII-105 ( Other Identifier: City of Hope Comprehensive Cancer Center )
8752 ( Other Identifier: CTEP )
P30CA033572 ( US NIH Grant/Contract Award Number )
N01CM00038 ( US NIH Grant/Contract Award Number )
Study First Received: November 10, 2010
Results First Received: June 10, 2015
Last Updated: September 3, 2015
Health Authority: United States: Food and Drug Administration