Trial of RAD001 and Erlotinib With Recurrent Head and Neck Squamous Cell Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Novartis
OSI Pharmaceuticals
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00942734
First received: July 20, 2009
Last updated: January 5, 2016
Last verified: January 2016
Results First Received: November 24, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Head And Neck Cancer
Interventions: Drug: Erlotinib
Drug: RAD001

  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: July 17, 2009 to February 08, 2013. Recruitment was done in various medical clinics in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the forty-nine participants registered, six participants were ineligible and not treated.

Reporting Groups
  Description
RAD001 + Erlotinib RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.

Participant Flow:   Overall Study
    RAD001 + Erlotinib  
STARTED     43  
COMPLETED     35  
NOT COMPLETED     8  
Adverse Event                 2  
Protocol Violation                 3  
Disease Progression                 2  
Physician Decision                 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.
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Reporting Groups
  Description
RAD001 + Erlotinib RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.

Baseline Measures
    RAD001 + Erlotinib  
Number of Participants  
[units: participants]
  43  
Age  
[units: years]
Median (Full Range)
  61  
  (38 to 75)  
Gender  
[units: participants]
 
Female     8  
Male     35  
Region of Enrollment  
[units: participants]
 
United States     43  



  Outcome Measures

1.  Primary:   12-Week Progression-Free Survival (PFS)   [ Time Frame: 12 weeks ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Vali Papadimitrakopoulou, MD
Organization: University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00942734     History of Changes
Other Study ID Numbers: 2008-0567
NCI-2012-01643 ( Registry Identifier: NCI CTRP )
Study First Received: July 20, 2009
Results First Received: November 24, 2015
Last Updated: January 5, 2016
Health Authority: United States: Food and Drug Administration