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Everolimus (RAD001) For Advanced Renal Cell Carcinoma (RCC) Before Kidney Removal

This study has been terminated.
(Difficulty in accrual and by the order of the cancer center.)
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Linda C. Higgins, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00831480
First received: January 27, 2009
Last updated: February 19, 2016
Last verified: December 2014
Results First Received: November 20, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Kidney Cancer
Intervention: Drug: 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
Fifteen subjects signed informed consents. Out of that 15, 9 took at least one dose of study drug.

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
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore

All subjects will take everolimus

everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.


Participant Flow:   Overall Study
    Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore
STARTED   9 
COMPLETED   7 
NOT COMPLETED   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.
Patients with clinically measurable metastatic RCC

Reporting Groups
  Description
Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore

All subjects will take everolimus

everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.


Baseline Measures
   Neoadjuvant Everolimus "RAD001" for Advanced RCC Before Cytore 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Full Range)
 58.9 
 (46 to 70) 
Age [1] 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   7 
>=65 years   2 
[1] Image and biopsy proven metastatic RCC
Gender 
[Units: Participants]
 
Female   2 
Male   7 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   7 
More than one race   0 
Unknown or Not Reported   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   1 
Not Hispanic or Latino   8 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   9 
Evidence of Metastatic Disease 
[Units: Participants]
 9 


  Outcome Measures

1.  Primary:   Disease Progression Diagnosed by Biopsy   [ Time Frame: up to one year ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Gilad E. Amiel
Organization: Baylor College of Medicine
phone: 713-798-4079
e-mail: lhiggins@bcm.edu



Responsible Party: Linda C. Higgins, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00831480     History of Changes
Other Study ID Numbers: H-23409
Study First Received: January 27, 2009
Results First Received: November 20, 2014
Last Updated: February 19, 2016
Health Authority: United States: Food and Drug Administration