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Efficacy of Everolimus Alone or in Combination With Pasireotide LAR in Advanced PNET (COOPERATE-2)

This study has been terminated.
(The study was stopped for not meeting the primary endpoint for PFS.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01374451
First received: June 14, 2011
Last updated: October 26, 2016
Last verified: October 2016
Results First Received: February 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Islet Cell Tumor
Interventions: Drug: Everolimus
Drug: Pasireotide LAR

  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
No text entered.

Reporting Groups
  Description
Paseriotide LAR + Everolimus everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
Everolimus everolimus 10 mg once daily po alone

Participant Flow:   Overall Study
    Paseriotide LAR + Everolimus   Everolimus
STARTED   79   81 
COMPLETED   78   81 
NOT COMPLETED   1   0 
Administrative problems                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.
Full analysis set (FAS) was defined according to the intention to treat principle. The FAS consisted of all randomized patients. Following the intention to treat principle patients were analyzed according to the treatment (and stratum) they were assigned to at randomization.

Reporting Groups
  Description
Paseriotide LAR + Everolimus everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
Everolimus everolimus 10 mg once daily po alone
Total Total of all reporting groups

Baseline Measures
   Paseriotide LAR + Everolimus   Everolimus   Total 
Overall Participants Analyzed 
[Units: Participants]
 79   81   160 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.52  (11.978)   58.22  (12.650)   57.38  (12.314) 
Gender 
[Units: Participants]
Count of Participants
     
Female      40  50.6%      34  42.0%      74  46.3% 
Male      39  49.4%      47  58.0%      86  53.8% 


  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS) Per Local Radiological Review   [ Time Frame: Once 80 PFS events had occurred aproximately after 24 months ]

2.  Secondary:   Safety and Tolerability Profile of Everolimus Alone or in Combination With Pasireotide LAR   [ Time Frame: Once 80 PFS events had occurred ]

3.  Secondary:   Objective Response Rate (ORR) as Per Radiology Review   [ Time Frame: Once 80 PFS events had occurred ]

4.  Secondary:   Duration of Response (DoR)   [ Time Frame: Once 80 PFS events had occurred ]

5.  Secondary:   Overall Survival (OS) Using Kaplan Meier Method   [ Time Frame: Once 80 PFS events had occurred ]

6.  Secondary:   PFS and the Predictive Probability of Success in Phase III   [ Time Frame: Once 105 PFS events had occurred occurred ]

7.  Secondary:   Disease Control Rate (DCR) as Per Radiology Review   [ Time Frame: Once 80 PFS events had occurred ]

8.  Secondary:   Summary of Pharmacokinetics (PK) for Everolimus for AUClast   [ Time Frame: Cycle 2 Day 1 ]

9.  Secondary:   Summary of Pharmacokinetics (PK) for Everolimus for CL/F   [ Time Frame: Cycle 2 Day 1 ]

10.  Secondary:   Summary of Pharmacokinetics (PK) for Everolimus for Cmax and Cmin   [ Time Frame: Cycle 2 Day 1 ]

11.  Secondary:   Summary of Pharmacokinetics (PK) for Everolimus for Tmax   [ Time Frame: Cycle 2 Day 1 ]

12.  Secondary:   Summary of Pasireotide Concentrations Following Intramuscular Injection of Pasireotide LAR 60mg   [ Time Frame: Cycle 1 Day 21, Cycle 2 Day 29 ]


  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
A planned primary analysis was completed with data cut of 02-Apr-2014. The study did not meet its primary objective, which was based on progression-free survival as per local radiology assessment and was prematurely terminated.


  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



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01374451     History of Changes
Other Study ID Numbers: CSOM230I2201
2010-023183-40 ( EudraCT Number )
Study First Received: June 14, 2011
Results First Received: February 16, 2016
Last Updated: October 26, 2016