Selumetinib and Akt Inhibitor MK2206 in Treating Patients With Stage III or Stage IV Melanoma Who Failed Prior Therapy With Vemurafenib or Dabrafenib

This study has been terminated.
(Study terminated due to slow accrual)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01519427
First received: January 25, 2012
Last updated: May 16, 2014
Last verified: January 2014
Results First Received: November 27, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Melanoma
Stage IIIA Melanoma
Stage IIIB Melanoma
Stage IIIC Melanoma
Stage IV Melanoma
Interventions: Drug: Akt inhibitor MK2206
Drug: selumetinib
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
Subjects were recruited from January 2012 through February 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four potential subjects consented. Two were ineligible.

Reporting Groups
  Description
Treatment (Selumetinib and Akt Inhibitor MK2206) Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.

Participant Flow:   Overall Study
    Treatment (Selumetinib and Akt Inhibitor MK2206)  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
disease progression                 2  



  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.
2 consented patients were not eligible for the trial

Reporting Groups
  Description
Treatment (Selumetinib and Akt Inhibitor MK2206) Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.

Baseline Measures
    Treatment (Selumetinib and Akt Inhibitor MK2206)  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  44  ± 14  
Gender  
[units: participants]
 
Female     1  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures
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1.  Primary:   Objective Response   [ Time Frame: On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment) ]

2.  Secondary:   Changes in Biomarker Expression   [ Time Frame: Before initiation of treatment and at 7-14 days, up to 2 years ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: On-study to lesser of date of progression or date of death from any cause, up to 2 years ]

4.  Secondary:   Overall Survival   [ Time Frame: On-study date to date of death from any cause, 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
Because this study terminated early due to slow accrual, data were available for only the two eligible patients that enrolled before study closure.


  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: Jeff Sosman, MD
Organization: Vanderbilt-Ingram Cancer Center
phone: 615-936-3048
e-mail: jeff.sosman@vanderbilt.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01519427     History of Changes
Obsolete Identifiers: NCT01510444
Other Study ID Numbers: NCI-2012-00238, NCI-2012-00238, CDR0000722048, VICCMEL1120, 8867, N01CM00100, 16950
Study First Received: January 25, 2012
Results First Received: November 27, 2013
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration