Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer
NCT ID: NCT00243503
Last Updated: 2011-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2006-02-28
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
SU011248/Trastuzumab
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
Interventions
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SU011248/Trastuzumab
SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.
Eligibility Criteria
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Inclusion Criteria
* HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive)
* Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.
Exclusion Criteria
* Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
* Prior treatment on a SU11248 clinical trial.
* Uncontrolled brain metastases.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Montgomery, Alabama, United States
Pfizer Investigational Site
Newark, Delaware, United States
Pfizer Investigational Site
Newark, Delaware, United States
Pfizer Investigational Site
Wilmington, Delaware, United States
Pfizer Investigational Site
Fort Lauderdale, Florida, United States
Pfizer Investigational Site
Harvey, Illinois, United States
Pfizer Investigational Site
Tinley Park, Illinois, United States
Pfizer Investigational Site
Munster, Indiana, United States
Pfizer Investigational Site
Lafayette, Louisiana, United States
Pfizer Investigational Site
New Iberia, Louisiana, United States
Pfizer Investigational Site
Corinth, Mississippi, United States
Pfizer Investigational Site
Southaven, Mississippi, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Ottignies, , Belgium
Pfizer Investigational Site
Wilrijk, , Belgium
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Greenfield Park, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Besançon, , France
Pfizer Investigational Site
Lyon, , France
Pfizer Investigational Site
Saint-Cloud, , France
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
Madrid, Madrid, Spain
Pfizer Investigational Site
Valencia, Valencia, Spain
Countries
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References
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Bachelot T, Garcia-Saenz JA, Verma S, Gutierrez M, Pivot X, Kozloff MF, Prady C, Huang X, Khosravan R, Wang Z, Cesari R, Tassell V, Kern KA, Blay JY, Lluch A. Sunitinib in combination with trastuzumab for the treatment of advanced breast cancer: activity and safety results from a phase II study. BMC Cancer. 2014 Mar 7;14:166. doi: 10.1186/1471-2407-14-166.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6181067
Identifier Type: -
Identifier Source: org_study_id
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