A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.

NCT00078000

Last updated date
Study Location
Pfizer Investigational Site
Greenbrae, California, 94904, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
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

- Anthracycline and taxane-refractory or intolerant metastatic breast cancer

- Female

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


- Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic
disease setting beyond those containing anthracyclines/taxanes.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.
Official Title  ICMJE A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer
Brief Summary Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who have failed selected other therapies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: SU011248
Study Arms  ICMJE Not Provided
Publications * Keyvanjah K, DePrimo SE, Harmon CS, Huang X, Kern KA, Carley W. Soluble KIT correlates with clinical outcome in patients with metastatic breast cancer treated with sunitinib. J Transl Med. 2012 Aug 16;10:165. doi: 10.1186/1479-5876-10-165.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2005)
64
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
63
Actual Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Anthracycline and taxane-refractory or intolerant metastatic breast cancer
  • Female

Exclusion Criteria:

  • Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines/taxanes.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00078000
Other Study ID Numbers  ICMJE A6181002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP