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Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00529802
First Posted: September 14, 2007
Last Update Posted: November 9, 2017
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:
Novartis
Information provided by (Responsible Party):
University of Chicago
Results First Submitted: October 27, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carcinoma, Renal Cell
Intervention: 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
A total of 60 patients started trial between December, 2007 and June, 2010 at 5 clinical sites. . A total of 63 patients signed consent, (1 withdrew consent, 2 failed screening)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This is a single-arm trial.

Reporting Groups
  Description
Everolimus All patients were to receive 10mg everolimus (RAD001) daily.

Participant Flow for 2 periods

Period 1:   Evaluable for Primary Endpoint
    Everolimus
STARTED   60 [1] 
COMPLETED   50 [2] 
NOT COMPLETED   10 
Did not complete 2d CT scan                3 
Worsening performance status                2 
Adverse Event                2 
Death                1 
Lack of Efficacy                1 
Lost to Follow-up                1 
[1] 60 patients started trial
[2] Evaluable for primary endpoint

Period 2:   Evaluable for Secondary Endpoint
    Everolimus
STARTED   50 
COMPLETED   48 
NOT COMPLETED   2 
Did not complete 2d FDG-PET scan                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.
No text entered.

Reporting Groups
  Description
Everolimus All patients were to receive 10mg everolimus (RAD001) daily.

Baseline Measures
   Everolimus 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Median (Full Range)
 60 
 (36 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      15  30.0% 
Male      35  70.0% 
Tumor Type 
[Units: Participants]
 
Clear Cell   36 
Papillary Cell   4 
Chromophobe   4 
Unclassified/Other   6 
Average SUVmax [1] 
[Units: Participants]
 
Low Uptake (avgSUVmax<=4)   10 
High Uptake (avgSUVmax>4)   40 
[1] The standardized uptake value (SUV) was calculated for each FDG-PET scan. The average of the maximum SUV (SUVmax) across all lesions (aveSUVmax) on the baseline scan was used to classify patients into low- and high-uptake. Low uptake group was defined as avgSUVmax <=4, and high uptake group was defined as avgSUVmax > 4.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Relative Tumor Size Change Following 8 Weeks of Therapy.   [ Time Frame: 8 weeks ]

2.  Secondary:   Percent Change in FDG-PETUptake Following 2 Weeks of Therapy   [ Time Frame: 2 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
No text entered.


  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: Walter Stadler, MD
Organization: The University of Chicago
phone: (773) 702-4150
e-mail: wstadler@medicine.bsd.uchicago.edu


Publications of Results:

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00529802     History of Changes
Other Study ID Numbers: 15599B
First Submitted: September 12, 2007
First Posted: September 14, 2007
Results First Submitted: October 27, 2016
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017