You are here

A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bahia Blanca, Prov. de Buenos Aires, B8001HXM Argentina
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- breast adenocarcinoma

- prior treatment with an anthracycline and a taxane either concurrently or sequentially
in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than
1 chemotherapy regimen in the advanced setting

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with regimens of chemotherapy in the advanced/metastatic disease
setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/
taxanes treatments.

- Any prior regimen with capecitabine

NCT00373113
Pfizer
Terminated
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
NCT01945775
All Genders
18+
Years
Multiple Sites
Advanced Breast Cancer, Metastatic Breast Cancer
NCT03280303
All Genders
18+
Years
Multiple Sites
Breast Neoplasms, Stomach Neoplasms, Esophagogastric Junction Neoplasm, Non-small-cell Lung Carcinoma
NCT03284723
All Genders
18+
Years
Multiple Sites
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
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
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
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Capecitabine
    1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
    Other Name: xeloda
  • Drug: Sunitinib malate
    37.5 mg daily, continuous dosing
    Other Name: sunitinib
  • Active Comparator: A
    1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
    Intervention: Drug: Capecitabine
  • Experimental: B
    37.5 mg daily, continuous dosing
    Intervention: Drug: Sunitinib malate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
482
June 2011
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • breast adenocarcinoma
  • prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria:

  • Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
  • Any prior regimen with capecitabine
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
 
 
NCT00373113
A6181107
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now