Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2003-05-31
2006-02-28
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
TREATMENT
NONE
Interventions
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MDX-010
Eligibility Criteria
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Inclusion Criteria
* diagnosed with Stage IV adenocarcinoma that has progressed despite previous therapy
* at least 18 years of age
* measurable disease defined by RECIST
* must discontinue any alternative therapy used to treat breast cancer at least 4 weeks prior to enrollment and agree to not use such therapies during the duration of the study (patients may continue to receive tamoxifen, bisphosphate therapy and trastuzumab)
* prior radiation must be completed at least 4 weeks prior to enrollment
* ECOG performance status of 0-2
* Negative pregnancy test
* Screening lab values must be met
Exclusion Criteria
* symptomatic or untreated brain metastases
* active or history of autoimmune disease
* active HIV, HTLV, HBV or HCV infection
* concurrent medical condition requiring the use of systemic corticosteroids, must be discontinued at least 4 weeks prior to enrollment
* prior therapy with anti-CTLA-4 antibody
* significant organ compromise, uncontrolled heart, liver, lung, or renal disease or other serious illness
* pregnancy or nursing
18 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Sharp Clinical Oncology Research
San Diego, California, United States
Wishard Health Services
Indianapolis, Indiana, United States
Section of Hematology/Oncology, Indiana Cancer Pavilion
Indianapolis, Indiana, United States
Indiana University, Clarian Health Partners
Indianapolis, Indiana, United States
Medical Arts Building
Jeffersonville, Indiana, United States
Kansas City Oncology and Hematology Group
Kansas City, Kansas, United States
Kansas City Oncology and Hematology Group
Overland Park, Kansas, United States
LaGrange
La Grange, Kentucky, United States
Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
Louisville, Kentucky, United States
Suburban Medical Plaza II
Louisville, Kentucky, United States
Audubon Oncology/Hematology
Louisville, Kentucky, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, United States
Kansas City Oncology and Hematology Group
Lee's Summit, Missouri, United States
Arlington Cancer Center
Arlington, Texas, United States
Countries
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Other Identifiers
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CA184-015
Identifier Type: OTHER
Identifier Source: secondary_id
MDX010-12
Identifier Type: -
Identifier Source: org_study_id
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