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Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01514448
First received: January 17, 2012
Last updated: July 17, 2017
Last verified: July 2017
Results First Received: March 31, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Metastatic Renal Cell Carcinoma (mRCC)
Intervention: Drug: Everolimus (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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Single arm study of everolimus broken down into 2 subgroups for analyses and safety based on failed 1st line therapy (sunitinib or pazopanib) prior to starting study.

Reporting Groups
  Description
1st Line SUN Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
1st Line PAZ Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.

Participant Flow:   Overall Study
    1st Line SUN   1st Line PAZ
STARTED   16   13 
Full Analysis Set (FAS)   12   13 
COMPLETED   4   5 
NOT COMPLETED   12   8 
Death                7                8 
Withdrawal by Subject                2                0 
Lost to Follow-up                2                0 
New Cancer Therapy                1                0 



  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.
Demographic and other baseline data (including disease characteristics) were summarized descriptively for all patients for the FAS. The full analysis set (FAS) consisted of all patients who received at least one dose of everolimus.

Reporting Groups
  Description
1st Line SUN Patients that failed 1st line therapy Sunitinib (SUN) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
1st Line PAZ Patients that failed 1st line therapy Pazopanib (PAZ) prior to starting study. Patients were on Everolimus 10 mg orally once daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawn consent.
Total Total of all reporting groups

Baseline Measures
   1st Line SUN   1st Line PAZ   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   13   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.6  (6.3)   71.3  (6.0)   69.2  (6.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  50.0%      2  15.4%      8  32.0% 
Male      6  50.0%      11  84.6%      17  68.0% 


  Outcome Measures
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1.  Primary:   Percentage of Progression-free Patients by Month 6   [ Time Frame: Month 6 ]

2.  Secondary:   Percentage of Patients With Overall Response Rate (ORR) Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy at Month 6   [ Time Frame: Month 6 ]

3.  Secondary:   Progression-Free Survival (PFS) as the Time Interval Between First Intake of Everolimus and First Documented Disease Progression or Death Due to Any Cause at 24 Months   [ Time Frame: 24 months ]

4.  Secondary:   Overall Survival (OS) of Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months   [ Time Frame: 48 months ]

5.  Secondary:   Duration of Response (DOR) in Patients Treated With Everolimus After Failure of First-line Sunitinib or Pazopanib Therapy up to 48 Months   [ Time Frame: 48 months ]


  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 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01514448     History of Changes
Other Study ID Numbers: CRAD001LDE43
2011-003416-23 ( EudraCT Number )
Study First Received: January 17, 2012
Results First Received: March 31, 2017
Last Updated: July 17, 2017