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Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01065844
First Posted: February 9, 2010
Last Update Posted: December 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Holden Comprehensive Cancer Center
Information provided by (Responsible Party):
John M. Buatti, University of Iowa
Results First Submitted: October 25, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Carcinoma, Adenoid Cystic
Head and Neck Neoplasms
Intervention: Drug: Nelfinavir

  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
Nelfinavir

1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday


Participant Flow:   Overall Study
    Nelfinavir
STARTED   15 
COMPLETED   10 
NOT COMPLETED   5 
Adverse Event                5 



  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
Nelfinavir

1250 mg Nelfinavir twice daily Monday-Sunday

Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday


Baseline Measures
   Nelfinavir 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age, Customized [1] 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      12  80.0% 
>=65 years      3  20.0% 
[1] Age, in years, of study participants at consent
Gender, Customized [1] 
[Units: Participants]
Count of Participants
 
Female      9  60.0% 
Male      6  40.0% 
[1] Self-reported gender at time of study enrollment
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Tumor Progression   [ Time Frame: Every 1 to 3 months ]

2.  Secondary:   Quality of Life   [ Time Frame: every 1 to 3 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Favorable selection criteria were used in study design. RECIST assessed at a median interval of 12 weeks - this difference in methods may have artificially prolonged the progression free survival observed in this study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: John M. Buatti, M.D., Chair, Department of Radiation Oncology
Organization: The University of Iowa
phone: 319-356-2699
e-mail: john-buatti@uiowa.edu


Publications of Results:
Other Publications:

Responsible Party: John M. Buatti, University of Iowa
ClinicalTrials.gov Identifier: NCT01065844     History of Changes
Other Study ID Numbers: 200905704
First Submitted: February 8, 2010
First Posted: February 9, 2010
Results First Submitted: October 25, 2016
Results First Posted: December 19, 2016
Last Update Posted: December 19, 2016