A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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 received (or were not candidates for) all available approved therapies for their breast cancer. This study will also further characterize the safety of CDX-011 treatment in this patient population.

Key facts

Study ID

NCT01156753

Run by

Celldex Therapeutics

People needed

120

Starts

2010-07-01

Expected to finish

2012-11-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of Alabama at Birmingham Comprehensive Cancer Center — Birmingham, Alabama, United States
• Arizona Cancer Center — Tucson, Arizona, United States
• Breastlink Medical Group — Long Beach, California, United States
• The Angeles Clinic and Research Institute — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Florida Cancer Specialists — West Coast, Florida, United States
• Peachtree Hematology-Oncology Consultants PC — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• Orchard Healthcare Research Inc. — Skokie, Illinois, United States
• Cancer Treatment Centers of America at Midwestern Regional Medical Center — Zion, Illinois, United States
• Cancer Care of Louisiana — New Orleans, Louisiana, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Montana Cancer Institute Foundation — Missoula, Montana, United States
• Clinical Research Alliance Inc. — Lake Success, New York, United States
• Weill Cornell Breast Center/Weill Cornell Medical College — New York, New York, United States
• Montefiore-Einstein Cancer Center — The Bronx, New York, United States
• Levine Cancer Institute/Blumenthal Cancer Center — Charlotte, North Carolina, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Guthrie Clinic, Ltd. — Sayre, Pennsylvania, United States
• South Carolina Oncology Associates — Columbia, South Carolina, United States
• Santee Hematology Oncology, Inc. — Sumter, South Carolina, United States
• Center for Biomedical Research — Knoxville, Tennessee, United States
• Sarah Cannon Research Institution — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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