Text Size

Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors (RADIANT-3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00510068
First received: July 31, 2007
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
Results First Received: November 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Advanced Neuroendocrine Tumors
Interventions: Drug: Everolimus
Drug: Placebo to Everolimus

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Everolimus 10 mg/Day Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
Placebo Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).

Participant Flow:   Overall Study
    Everolimus 10 mg/Day     Placebo  
STARTED     207     203  
Safety Population     204     203  
COMPLETED     141 [1]   177  
NOT COMPLETED     66     26  
On-going, on study drug                 66                 26  
[1] Study treatment was discontinued by patients of both arms as of 28-Feb-2010, data cut-off date.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Everolimus 10 mg/Day Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
Placebo Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
Total Total of all reporting groups

Baseline Measures
    Everolimus 10 mg/Day     Placebo     Total  
Number of Participants  
[units: participants]
 		  207     203     410  
Age  
[units: years]
Mean ± Standard Deviation 		  57.1  ± 12.2     56.2  ± 11.4     56.6  ± 11.8  
Gender  
[units: participants]
 		     
Female     97     86     183  
Male     110     117     227  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology   [ Time Frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants With Objective Response Rate ( CR {Complete Response} OR PR {Partial Response})   [ Time Frame: Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs)   [ Time Frame: on or after the start of double-blind study medication until no later than 28 days after double-blind study medication discontinuation ]
  Show Outcome Measure 3

4.  Secondary:   Time to Overall Survival   [ Time Frame: Baseline, to death- no time limit ]
Results not yet posted.   Anticipated Posting Date:   07/2013   Safety Issue:   Yes

5.  Secondary:   Evaluation of Pharmacokinetics (PK) Parameters   [ Time Frame: Day 1 of every cycle (28 days/cycle) throughout the study ]
Results not yet posted.   Anticipated Posting Date:   07/2013   Safety Issue:   No

6.  Secondary:   Changes From Baseline in Serum Biochemical Tumor Markers, Such as Chromogranin A (CgA) and Neuron Specific Enolase (NSE)   [ Time Frame: If elevated at baseline, evaluated every cycle visit (28 days/cycle) ]
Results not yet posted.   Anticipated Posting Date:   07/2013   Safety Issue:   No


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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.


Limitations and Caveats
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.  


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


No publications provided by Novartis

Publications automatically indexed to this study:


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00510068     History of Changes
Other Study ID Numbers: CRAD001C2324, EudraCT 2006-006819-75
Study First Received: July 31, 2007
Results First Received: November 11, 2011
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration