Phase II Trial of RAD001 (Everolimus) in Previously Treated Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00374140
First received: September 6, 2006
Last updated: January 8, 2014
Last verified: December 2013
Results First Received: January 8, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Small Cell Lung Cancer
Intervention: Drug: RAD001 (everolimus)

  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
RAD001 (Everolimus) RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities

Participant Flow:   Overall Study
    RAD001 (Everolimus)  
STARTED     40  
COMPLETED     38  
NOT COMPLETED     2  
Lost to Follow-up                 1  
Protocol Violation                 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 (Everolimus) RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities

Baseline Measures
    RAD001 (Everolimus)  
Number of Participants  
[units: participants]
  40  
Age, Customized  
[units: years]
Median ( Full Range )
  64  
  ( 44 to 80 )  
Gender  
[units: participants]
 
Female     26  
Male     14  



  Outcome Measures

1.  Primary:   Determine the Proportion of Previously Treated Small Cell Lung Cancer (SCLC) Patients Whose Disease Has Not Progressed Following 6-weeks (2 Cycles) of Treatment With RAD001.   [ Time Frame: Two cycles of treatment with RAD001 (~6 weeks) ]

2.  Secondary:   To Determine Overall Survival, Progression-free Survival, Objective Response Rate, and Toxicities.   [ Time Frame: Followed until progression and death ]
Results not yet posted.   Anticipated Posting 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ahmad Tarhini, MD, PhD
Organization: University of Pittsburgh
phone: (412) 648-6578
e-mail: tarhiniaa@upmc.edu


No publications provided


Responsible Party: Ahmad Tarhini, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00374140     History of Changes
Other Study ID Numbers: 06-049
Study First Received: September 6, 2006
Results First Received: January 8, 2014
Last Updated: January 8, 2014
Health Authority: United States: Food and Drug Administration