A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
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 glycoprotein NMB (GPNMB) that is expressed on the cancer cell. The MMAE is then
released inside of the cell, where it interferes with cell growth and may lead to cell
death.
This study will examine the effectiveness and safety of CDX-011 in patients with advanced
breast cancer that makes the GPNMB protein. To better assess this, the effect of CDX-011
will be compared to treatment with currently available cancer chemotherapy.
Eligible patients who enroll in the study will be randomly assigned by chance to receive
treatment with CDX-011 or with a chemotherapy chosen by their study doctor from a list of
currently available drugs ("Investigator's Choice" chemotherapy). For each three patients
enrolled, two will receive CDX-011 and one will receive treatment with "Investigator's
Choice". Patients initially assigned to "Investigator's Choice" chemotherapy may be offered
treatment with CDX-011 if their cancer worsens during this initial treatment.
All patients enrolled in the study will be closely monitored to determine if their cancer is
responding to treatment, and for any side effects that may occur.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate
The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.
6 or more weeks following treatment initiation
No
United States: Food and Drug Administration
CDX011-03
NCT01156753
July 2010
November 2012
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Georgia Cancer Specialists | Decatur, Georgia 30033 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Center for Biomedical Research | Knoxville, Tennessee 37909 |
South Carolina Oncology Associates | Columbia, South Carolina 29201 |
Henry Ford Health System | Detroit, Michigan 48202 |
The Angeles Clinic and Research Institute | Los Angeles, California 90025 |
Oncology Hematology Care | Cincinnati, Ohio 45242 |
Montana Cancer Institute Foundation | Missoula, Montana 59802 |
Montefiore-Einstein Cancer Center | Bronx, New York 10461 |
Orchard Healthcare Research Inc. | Skokie, Illinois 60076 |
The University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294 |
Breastlink Medical Group | Long Beach, California 90806 |
Peachtree Hematology-Oncology Consultants PC | Atlanta, Georgia 30318 |
Cancer Treatment Centers of America at Midwestern Regional Medical Center | Zion, Illinois 60099 |
Cancer Care of Louisiana | New Orleans, Louisiana 70115 |
Clinical Research Alliance Inc. | Lake Success, New York 11042 |
Weill Cornell Breast Center/Weill Cornell Medical College | New York, New York 10065 |
Levine Cancer Institute/Blumenthal Cancer Center | Charlotte, North Carolina 28203 |
Guthrie Clinic, Ltd. | Sayre, Pennsylvania 18840 |
Santee Hematology Oncology, Inc. | Sumter, South Carolina 29150 |
Sarah Cannon Research Institution | Nashville, Tennessee 37203 |