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Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin) (RADIANT-4)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01524783
First received: December 22, 2011
Last updated: November 1, 2016
Last verified: November 2016
Results First Received: March 26, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Advanced NET of GI Origin
Advanced NET of Lung Origin
Neuroendocrine Tumors
Interventions: Drug: Everolimus
Drug: Everolimus Placebo

  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
205 patients were randomized but only 203 patients received study drug. (Two patients randomized to everolimus were not treated due to withdrawal of consent and protocol deviation and one patient randomized to everolimus inadvertently received placebo treatment).

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 + BSC Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
Everolimus Placebo + BSC Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)

Participant Flow for 2 periods

Period 1:   Randomized But Not Treated
    Everolimus + BSC   Everolimus Placebo + BSC
STARTED   205   97 
COMPLETED   203 [1]   97 [1] 
NOT COMPLETED   2   0 
Randomized, did not receive drug                2                0 
[1] Completed = Participants randomized and treated with study drug

Period 2:   Randomized and Treated
    Everolimus + BSC   Everolimus Placebo + BSC
STARTED   203   97 
COMPLETED   48 [1]   13 [1] 
NOT COMPLETED   155   84 
Adverse Event                59                7 
Disease Progression                76                70 
Withdrawal by Subject                15                5 
Protocol Violation                1                1 
Death                4                1 
[1] Completed = Patients with ongoing treatment at the time of data cut-off of 28-Nov-2014.



  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.
The full analysis set (FAS) consists of all randomized patients. Following the intent-to-treat principle, patients were analyzed according to the treatment arm and stratification factors they were assigned to at randomization.

Reporting Groups
  Description
Everolimus + BSC Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
Everolimus Placebo + BSC Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
Total Total of all reporting groups

Baseline Measures
   Everolimus + BSC   Everolimus Placebo + BSC   Total 
Overall Participants Analyzed 
[Units: Participants]
 205   97   302 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.9  (11.70)   59.4  (12.89)   61.7  (12.18) 
Gender 
[Units: Participants]
Count of Participants
     
Female      116  56.6%      44  45.4%      160  53.0% 
Male      89  43.4%      53  54.6%      142  47.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS) Based on Central Radiology Assessment Per Kaplan-Meier   [ Time Frame: From date of randomization to progression or death up to 18 months ]

2.  Secondary:   Overall Survival (OS) Using Kaplan-Meier   [ Time Frame: Every visit from randomization up to 18 months ]

3.  Secondary:   Overall Safety Evaluation of Everolimus Versus Placebo   [ Time Frame: Every visit from randomization up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   FACT-G Total Score Over the Duration of the Study   [ Time Frame: Every Visit from randomization up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Every Visit from randomization up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Disease Control Rate (DCR)   [ Time Frame: 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Change in Chromogranin A (CgA) and Neuron Specific Enolase (NSE) Levels During the Study   [ Time Frame: Every visit from baseline up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Time to Definitive Deterioration in WHO Performance Status Change During the Study   [ Time Frame: Every visit up from randomization to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Pharmacokinetics (PK)   [ Time Frame: Visit 3 (Cycle 2, Study Day 29) ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Two patients randomized to everolimus were not treated due to withdrawal of consent and protocol deviation and one patient randomized to everolimus inadvertently received placebo treatment.


  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
e-mail: trialandresults.registries@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01524783     History of Changes
Other Study ID Numbers: CRAD001T2302
2011-002887-26 ( Registry Identifier: EudraCT )
Study First Received: December 22, 2011
Results First Received: March 26, 2016
Last Updated: November 1, 2016