A Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
EMERGE
A Phase II, Randomized, Multicenter Study of CDX-011 (CR011-vcMMAE) in Patients With Advanced GPNMB-expressing Breast Cancer
1 other identifier
interventional
120
1 country
24
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jul 2010
Shorter than P25 for phase_2 breast-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedFirst Posted
Study publicly available on registry
July 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedJuly 2, 2017
June 1, 2017
2.3 years
June 30, 2010
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Progression-free survival
At least 18 months following treatment initiation
Adverse Events
Usually following at least 1 cycle of study treatment (1 dose of CDX-011 or "Investigator's Choice" chemotherapy and 3 to 4 weeks of follow-up)
Study Arms (2)
CDX-011
EXPERIMENTAL"Investigator's Choice" chemotherapy
ACTIVE COMPARATORInterventions
CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.
Any of the following single-agent chemotherapy may be given at the discretion of the investigator, with a cycle length not to exceed four weeks: Capecitabine, Vinorelbine, Gemcitabine, Docetaxel, Paclitaxel, Albumin-bound paclitaxel, Doxorubicin HCL, Liposomal doxorubicin, Ixabepilone and Eribulin.
Eligibility Criteria
You may qualify if:
- Among other criteria, patients must meet all of the following conditions to be eligible for the study:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
The University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
Arizona Cancer Center
Tucson, Arizona, 85724, United States
Breastlink Medical Group
Long Beach, California, 90806, United States
The Angeles Clinic and Research Institute
Los Angeles, California, 90025, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143, United States
Florida Cancer Specialists
West Coast, Florida, United States
Peachtree Hematology-Oncology Consultants PC
Atlanta, Georgia, 30318, United States
Georgia Cancer Specialists
Atlanta, Georgia, 30341, United States
Orchard Healthcare Research Inc.
Skokie, Illinois, 60076, United States
Cancer Treatment Centers of America at Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Cancer Care of Louisiana
New Orleans, Louisiana, 70115, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Montana Cancer Institute Foundation
Missoula, Montana, 59802, United States
Clinical Research Alliance Inc.
Lake Success, New York, 11042, United States
Weill Cornell Breast Center/Weill Cornell Medical College
New York, New York, 10065, United States
Montefiore-Einstein Cancer Center
The Bronx, New York, 10467, United States
Levine Cancer Institute/Blumenthal Cancer Center
Charlotte, North Carolina, 28203, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Guthrie Clinic, Ltd.
Sayre, Pennsylvania, 18840, United States
South Carolina Oncology Associates
Columbia, South Carolina, 29210, United States
Santee Hematology Oncology, Inc.
Sumter, South Carolina, 29150, United States
Center for Biomedical Research
Knoxville, Tennessee, 37909, United States
Sarah Cannon Research Institution
Nashville, Tennessee, 37203, United States
Related Publications (1)
Yardley DA, Weaver R, Melisko ME, Saleh MN, Arena FP, Forero A, Cigler T, Stopeck A, Citrin D, Oliff I, Bechhold R, Loutfi R, Garcia AA, Cruickshank S, Crowley E, Green J, Hawthorne T, Yellin MJ, Davis TA, Vahdat LT. EMERGE: A Randomized Phase II Study of the Antibody-Drug Conjugate Glembatumumab Vedotin in Advanced Glycoprotein NMB-Expressing Breast Cancer. J Clin Oncol. 2015 May 10;33(14):1609-19. doi: 10.1200/JCO.2014.56.2959. Epub 2015 Apr 6.
PMID: 25847941BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2010
First Posted
July 5, 2010
Study Start
July 1, 2010
Primary Completion
October 1, 2012
Study Completion
November 1, 2012
Last Updated
July 2, 2017
Record last verified: 2017-06