A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00373113
First received: September 5, 2006
Last updated: June 15, 2012
Last verified: June 2012
Results First Received: October 20, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: Capecitabine
Drug: Sunitinib malate

  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
Sunitinib 37.5 milligrams (mg) daily, continuous dosing
Capecitabine 1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Participant Flow:   Overall Study
    Sunitinib     Capecitabine  
STARTED     238     244  
Received Treatment     238     240  
COMPLETED     0     0  
NOT COMPLETED     238     244  
Death                 1                 7  
Adverse Event                 38                 24  
Study terminated by sponsor                 9                 1  
Global deterioration of health status                 10                 7  
Lost to Follow-up                 1                 3  
Objective progression or relapse                 150                 169  
Unspecified                 14                 17  
Protocol Violation                 5                 1  
Withdrawal by Subject                 10                 15  



  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.
No text entered.

Reporting Groups
  Description
Sunitinib 37.5 mg daily, continuous dosing
Capecitabine 1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
Total Total of all reporting groups

Baseline Measures
    Sunitinib     Capecitabine     Total  
Number of Participants  
[units: participants]
  238     244     482  
Age, Customized  
[units: Participants]
     
18 to 44 years     50     70     120  
45 to 64 years     159     129     288  
> = 65 years     29     45     74  
Gender, Customized  
[units: Participants]
     
Female     238     244     482  
Male     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or until death ]

2.  Secondary:   Time to Tumor Progression (TTP)   [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months ]

3.  Secondary:   Number of Participants With Overall Response (OR)   [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months ]

4.  Secondary:   Duration of Response (DR)   [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or death ]

5.  Secondary:   Time to Tumor Response (TTR)   [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: From time of randomization until death ]

7.  Secondary:   European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)   [ Time Frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter ]

8.  Secondary:   EORTC QLQ Breast Cancer Module (BR23)   [ Time Frame: From Day 1 of Cycle 1, then odd numbered cycles thereafter ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
Due to patient enrollment termination, PFS/OR/TTP/DR were done by investigator assessment due to lack of central review data and TTR/EORTC QLQ-C30/QLQ BR23 analyses were not done. Those enrolled could receive capecitabine or enter an extension trial.  


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


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00373113     History of Changes
Other Study ID Numbers: A6181107
Study First Received: September 5, 2006
Results First Received: October 20, 2010
Last Updated: June 15, 2012
Health Authority: United States: Food and Drug Administration