Akt Inhibitor MK2206 in Treating Patients With Advanced Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01277757
First received: January 13, 2011
Last updated: July 20, 2016
Last verified: June 2016
Results First Received: October 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: Akt Inhibitor MK2206
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

  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
Recruitment Period: March 14, 2011 to November 27, 2013. Recruitment done at The University of Texas MD Anderson Cancer Center, Beth-Israel Deaconness, Columbia University Medical Center, Dana Farber Cancer Center and Vanderbilt University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 30 participants registered, two were ineligible, not treated therefore excluded from the trial outcomes.

Reporting Groups
  Description
Akt Inhibitor MK-2206 Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.

Participant Flow:   Overall Study
    Akt Inhibitor MK-2206  
STARTED     30  
COMPLETED     28  
NOT COMPLETED     2  
Disease Progression                 1  
Withdrawal by Subject                 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.
Two participants were not treated.

Reporting Groups
  Description
Akt Inhibitor MK-2206 Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.

Baseline Measures
    Akt Inhibitor MK-2206  
Number of Participants  
[units: participants]
  30  
Age  
[units: years]
Median (Full Range)
  52.5  
  (31 to 74)  
Gender  
[units: participants]
 
Female     30  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Response Defined Using Response Evaluation Criteria In Solid Tumors (RECIST)   [ Time Frame: Up to 3 weeks after completion of study treatment, for up to 1 year ]

2.  Primary:   Number of Participants With Objective Response   [ Time Frame: 4 weeks following beginning treatment, repeat confirmation 4-6 weeks following response, up to 1 year ]

3.  Secondary:   6 Month Progression-free Survival (PFS)   [ Time Frame: From start of treatment to time of progression or death or six months whichever occurs first, assessed at 6 months ]

4.  Secondary:   Median Response Duration   [ Time Frame: Response assessment 4 weeks from beginning of treatment, response recorded from the start of treatment until disease progression/recurrence, up to 1 year ]

5.  Secondary:   Cell Proliferation as Measured by the Change in Percent Ki-67 Positive Cells   [ Time Frame: Baseline to 2 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Apoptosis Assessed by Cleaved Caspase-3   [ Time Frame: Up to 30 days after completion of study treatment, up to 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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: Funda Meric-Bernstam, MD/Chair, Investigational Cancer Therapeutics
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 713-563-4347
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01277757     History of Changes
Other Study ID Numbers: NCI-2012-02892
NCI-2012-02892 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000694003
NCI-2011-00246
MDACC 2010-0242
2010-0242 ( Other Identifier: M D Anderson Cancer Center )
8732 ( Other Identifier: CTEP )
N01CM00039 ( US NIH Grant/Contract Award Number )
N01CM62202 ( US NIH Grant/Contract Award Number )
P30CA016672 ( US NIH Grant/Contract Award Number )
U01CA062490 ( US NIH Grant/Contract Award Number )
Study First Received: January 13, 2011
Results First Received: October 14, 2015
Last Updated: July 20, 2016
Health Authority: United States: Food and Drug Administration