Akt Inhibitor MK2206 in Treating Patients With Progressive, Recurrent, or Metastatic Adenoid Cyst Carcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01604772
First received: May 22, 2012
Last updated: June 4, 2015
Last verified: July 2014
Results First Received: June 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Recurrent Oral Cavity Adenoid Cystic Carcinoma
Recurrent Salivary Gland Carcinoma
Salivary Gland Adenoid Cystic Carcinoma
Stage IVA Major Salivary Gland Carcinoma
Stage IVA Oral Cavity Adenoid Cystic Carcinoma
Stage IVB Major Salivary Gland Carcinoma
Stage IVB Oral Cavity Adenoid Cystic Carcinoma
Stage IVC Major Salivary Gland Carcinoma
Stage IVC Oral Cavity Adenoid Cystic 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
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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)

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: 150 mg given PO


Participant Flow:   Overall Study
    Treatment (Akt Inhibitor MK2206)  
STARTED     16  
COMPLETED     16  
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.
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Reporting Groups
  Description
Treatment (Akt Inhibitor MK2206)

Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: 150 mg given PO


Baseline Measures
    Treatment (Akt Inhibitor MK2206)  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Median (Full Range)
  63.5   (31 to 76)  
Gender  
[units: participants]
 
Female     10  
Male     6  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
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1.  Primary:   Confirmed Response Rate (Complete Response + Partial Response) According to RECIST Version 1.1   [ Time Frame: Up to 32 weeks ]

2.  Secondary:   Median Progression Free Survival   [ Time Frame: Time of study entry to progression or death, up to 3 years after registration ]

3.  Secondary:   Overall Survival   [ Time Frame: Time of study entry to death due to any cause, assessed up to 3 years from registration ]

4.  Secondary:   Incidence of Toxicities of Akt Inhibitor MK-2206   [ Time Frame: Time to first treatment to up to 30 days after completion of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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: Alan Ho, M.D.
Organization: Memorial Sloan Kettering Cancer Center
e-mail: hoa@mskcc.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01604772     History of Changes
Other Study ID Numbers: NCI-2012-01966, NCI-2012-01966, CDR0000733948, CALGB-A091104, A091104, A091104, N01CM62206, R01CA166978, U10CA031946, U10CA180821
Study First Received: May 22, 2012
Results First Received: June 4, 2015
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration