Status:
COMPLETED
A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
Lead Sponsor:
Celldex Therapeutics
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The main purpose of this study is to see whether CDX-011 is effective in treating patients who have advanced breast cancer that makes a protein called glycoprotein NMB (GPNMB), and who have already re...
Detailed Description
CDX-011 consists of an antibody attached to a drug, monomethyl auristatin E (MMAE), that can kill cancer cells. The antibody delivers the drug to cancer cells by attaching to a protein called glycopro...
Eligibility Criteria
Inclusion
- Among other criteria, patients must meet all of the following conditions to be eligible for the study:
- 18 years of age or older.
- Locally advanced or metastatic breast cancer.
- Previous treatment with at least two but no more than seven prior chemotherapy treatments for progressive, recurrent or metastatic breast cancer.
- Unless not a candidate for these agents, prior therapies must have included a taxane, an anthracycline, and capecitabine, as well as trastuzumab and lapatinib for patients whose tumors are positive for the human epidermal growth factor receptor 2 (HER2). (Patients who received incomplete courses of therapy with these agents due to intolerance will be eligible.)
- Breast cancer tumor confirmed to express GPNMB. This will be determined by submitting a tissue sample (obtained during a diagnostic biopsy or surgery) to a central laboratory for analysis.
Exclusion
- Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:
- Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.
- Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.
- Significant cardiovascular disease or any other underlying medical condition that, in the Investigator's opinion, will make the administration of study treatment (CDX-011 or chemotherapy) hazardous or would obscure the interpretation of side effects.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01156753
Start Date
July 1 2010
End Date
November 1 2012
Last Update
July 2 2017
Active Locations (24)
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1
The University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Arizona Cancer Center
Tucson, Arizona, United States, 85724
3
Breastlink Medical Group
Long Beach, California, United States, 90806
4
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025