- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00083278
Study of MDX-010 in Stage IV Breast Cancer
April 26, 2012 updated by: Bristol-Myers Squibb
A Phase II Study of MDX-010 in Patients With Stage IV Adenocarcinoma of the Breast
This Phase II study is designed to treat patients who have been diagnosed with Stage IV Breast Cancer, which has progressed despite treatment with primary therapies, including hormonal therapy, chemotherapy, and antibody therapy.
Thirty-three patients will be treated with the monoclonal antibody MDX-010.
The initial antitumor activity profile of MDX-010 will be determined, as well as identification of the induction of any antitumor immunity following the MDX-010 treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Diego, California, United States, 92123
- Sharp Clinical Oncology Research
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Indiana
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Indianapolis, Indiana, United States, 46202-2859
- Wishard Health Services
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Indianapolis, Indiana, United States, 46202-5289
- Section of Hematology/Oncology, Indiana Cancer Pavilion
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Indianapolis, Indiana, United States, 46202
- Indiana University, Clarian Health Partners
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Jeffersonville, Indiana, United States, 47130
- Medical Arts Building
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Kansas
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Kansas City, Kansas, United States, 66112
- Kansas City Oncology and Hematology Group
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Overland Park, Kansas, United States, 66210
- Kansas City Oncology and Hematology Group
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Kentucky
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LaGrange, Kentucky, United States, 40031
- LaGrange
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Louisville, Kentucky, United States, 40202
- Norton Healthcare Inc, Loiusville Oncology Clinical Research Program
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Louisville, Kentucky, United States, 40207
- Suburban Medical Plaza II
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Louisville, Kentucky, United States, 40217
- Audubon Oncology/Hematology
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Missouri
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Kansas City, Missouri, United States, 64131
- Kansas City Oncology and Hematology Group
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Lee's Summit, Missouri, United States, 64064
- Kansas City Oncology and Hematology Group
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Texas
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Arlington, Texas, United States, 76012
- Arlington Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Provide written informed consent
- 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:
- must be disease free from other cancers for at least 5 years
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
May 17, 2004
First Submitted That Met QC Criteria
May 19, 2004
First Posted (Estimate)
May 20, 2004
Study Record Updates
Last Update Posted (Estimate)
April 27, 2012
Last Update Submitted That Met QC Criteria
April 26, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Breast Neoplasms
- Adenocarcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Ipilimumab
Other Study ID Numbers
- MDX010-12
- CA184-015 (Other Identifier: BMS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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