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A Phase II Study of Akt Inhibitor MK2206 in the Treatment of Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01283035
First received: January 24, 2011
Last updated: May 16, 2016
Last verified: May 2016
Results First Received: February 16, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Ovarian Sarcoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal 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
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Reporting Groups
  Description
Treatment (Akt Inhibitor MK2206)

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Akt Inhibitor MK2206)
STARTED   6 
COMPLETED   5 
NOT COMPLETED   1 
Subject later found ineligible                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.
No text entered.

Reporting Groups
  Description
Treatment (Akt Inhibitor MK2206)

Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.

Akt Inhibitor MK2206: Given PO

Laboratory Biomarker Analysis: Correlative studies


Baseline Measures
   Treatment (Akt Inhibitor MK2206) 
Overall Participants Analyzed 
[Units: Participants]
 5 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   3 
>=65 years   2 
Gender 
[Units: Participants]
 
Female   5 
Male   0 
Region of Enrollment 
[Units: Participants]
 
United States   5 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer   [ Time Frame: Up to 3 years ]

2.  Secondary:   Association Between Select Biomarkers and Response to Akt Inhibitor MK2206 (as Assessed by Objective Tumor Response, Progression-free Survival, and Overall Survival)   [ Time Frame: Up to 3 years ]

3.  Secondary:   Development of Feedback Loop Activation and Target Inhibition With Akt Inhibitor MK2206 Via Analysis of Pre-treatment and Post-treatment Biopsies in Select Patients Enrolled in the Trial   [ Time Frame: Up to 3 years ]

4.  Secondary:   Duration of Overall Survival Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study   [ Time Frame: Up to 3 years ]

5.  Secondary:   Duration of Progression-free Following Initiation of Therapy With Akt Inhibitor MK2206 in the Cohort of Patients Enrolled on This Study   [ Time Frame: Up to 3 years ]

6.  Secondary:   Toxicities of Akt Inhibitor MK2206, as Assessed by the Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)   [ Time Frame: Up to 3 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 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: Joyce Liu, MD, MPH
Organization: DFCI
phone: 617-632-5269
e-mail: joyce_liu@dfci.harvard.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01283035     History of Changes
Other Study ID Numbers: NCI-2013-00549
NCI-2013-00549 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10-402 ( Other Identifier: Dana-Farber Cancer Institute )
8729 ( Other Identifier: CTEP )
P30CA006516 ( US NIH Grant/Contract Award Number )
Study First Received: January 24, 2011
Results First Received: February 16, 2016
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration