Efficacy And Safety Of Sunitinib In Patients With Advanced Well-Differentiated Pancreatic Neuroendocrine Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121562
First received: May 10, 2010
Last updated: June 18, 2014
Last verified: June 2014
Results First Received: July 1, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Neuroendocrine Tumors
Intervention: Drug: Sunitinib

  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
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Reporting Groups
  Description
Sunitinib Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).

Participant Flow:   Overall Study
    Sunitinib  
STARTED     12  
COMPLETED     0  
NOT COMPLETED     12  
Objective progression or relapse                 8  
Withdrawal by Subject                 1  
Adverse Event                 1  
Sponsor Decision                 1  
Met study discontinuation criteria                 1  



  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.
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Reporting Groups
  Description
Sunitinib Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).

Baseline Measures
    Sunitinib  
Number of Participants  
[units: participants]
  12  
Age  
[units: years]
Mean ± Standard Deviation
  54.1  ± 13.0  
Gender  
[units: participants]
 
Female     4  
Male     8  



  Outcome Measures
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1.  Primary:   Clinical Benefit Response Rate (CBR)   [ Time Frame: Up to 799 days of treatment ]

2.  Secondary:   Objective Response Rate (ORR)   [ Time Frame: Up to 799 days of treatment ]

3.  Secondary:   Tumor Shrinkage   [ Time Frame: Up to 799 days of treatment ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Up to 799 days of treatment ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 3 years from the last subject registration to the study ]

6.  Secondary:   Dose-corrected Trough Plasma Concentrations of Sunitinib, SU012662 and Total Drug (Sunitinib + SU012662).   [ Time Frame: Predose of Cycle 1 Day15, Cycle 2 Day1, Cycle 3 Day1, and Cycle 4 Day 1 ]


  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: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121562     History of Changes
Other Study ID Numbers: A6181193
Study First Received: May 10, 2010
Results First Received: July 1, 2012
Last Updated: June 18, 2014
Health Authority: United States: Food and Drug Administration