Trial record 1 of 1 for:
NCT00373113
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00373113 |
Recruitment Status :
Terminated
(See termination reason in detailed description.)
First Posted : September 7, 2006
Results First Posted : November 18, 2010
Last Update Posted : June 25, 2012
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | September 5, 2006 | |||
First Posted Date ICMJE | September 7, 2006 | |||
Results First Submitted Date ICMJE | October 20, 2010 | |||
Results First Posted Date ICMJE | November 18, 2010 | |||
Last Update Posted Date | June 25, 2012 | |||
Study Start Date ICMJE | November 2006 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Progression-Free Survival (PFS) [ Time Frame: From time of randomization to every 6 weeks thereafter through 22 months or until death ] Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.
|
|||
Original Primary Outcome Measures ICMJE |
Progression-free survival comparing Sunitinib with Capecitabine | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
Time to Tumor Progression Overall Response Duration of response Overall Survival Overall survival Patient-reported outcomes Safety | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine | |||
Official Title ICMJE | Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated | |||
Brief Summary | To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated | |||
Detailed Description | Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
|||
Condition ICMJE | Breast Neoplasms | |||
Intervention ICMJE |
|
|||
Study Arms ICMJE |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
482 | |||
Original Enrollment ICMJE |
700 | |||
Actual Study Completion Date ICMJE | June 2011 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender ICMJE |
|
|||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Colombia, France, Germany, Hong Kong, India, Italy, Japan, Korea, Republic of, Mexico, Peru, Philippines, Singapore, South Africa, Spain, Taiwan, Turkey, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00373113 | |||
Other Study ID Numbers ICMJE | A6181107 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | Pfizer | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |