Breast Cancer Clinical Trial

Study of Glembatumumab Vedotin (CDX-011) in Patients With Metastatic, gpNMB Over-Expressing, Triple Negative Breast Cancer

Summary

The main purpose of this study is to see whether CDX-011 (glembatumumab vedotin, an antibody-drug conjugate) is effective in treating patients who have advanced Triple-Negative Breast Cancer (TNBC), and whose tumor cells make a protein called glycoprotein NMB (gpNMB), which CDX-011 binds to. The study will also further characterize the safety of CDX-011 treatment in this patient population.

View Full Description

Full 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 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 efficacy and safety of CDX-011 in patients with advanced TNBC that makes the gpNMB protein. The effect of CDX-011 will be compared to treatment with capecitabine.

Eligible patients who enroll in the study will be randomly assigned (by chance) to receive treatment with CDX-011 or with capecitabine. For every three patients enrolled, two will receive CDX-011 and one will receive treatment with capecitabine. 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Among other criteria, patients must meet all of the following conditions to be eligible for the study:

Diagnosed with metastatic (i.e., cancer that has spread) TNBC

minimal or no expression of estrogen and progesterone receptors (ER/PR) <10% of cells positive by immunohistochemistry
HER 2 staining 0 or 1+ by IHC or copy number <4.0 signals/cell
Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.
Breast cancer tumor confirmed to express gpNMB. This will be determined by submitting a tissue sample from the advanced (locally advanced/recurrent or metastatic) disease setting to a central laboratory for analysis.
Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.
Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).
ECOG performance status of 0 - 1.
Adequate bone marrow, liver and renal function.

Exclusion:

Among other criteria, patients who meet any of the following conditions are NOT eligible for the study:

Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.
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.
Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.
Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.
Chronic use of systemic corticosteroids.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

327

Study ID:

NCT01997333

Recruitment Status:

Completed

Sponsor:

Celldex Therapeutics

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There are 136 Locations for this study

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Alabama Oncology
Birmingham Alabama, 35211, United States
University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
University of South Alabama Cancer Research Insititute
Mobile Alabama, 36604, United States
Arizona Cancer Research Alliance
Glendale Arizona, 85304, United States
Arizona Cancer Center
Tucson Arizona, 85724, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Compassionate Care Research Group
Fountain Valley California, 92708, United States
St. Jude Heritage Medical Group
Fullerton California, 92835, United States
USC Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90033, United States
University of California Davis Medical Center
Sacramento California, 95817, United States
Pacific Cancer Care
Salinas California, 93901, United States
University of California San Francisco
San Francisco California, 94115, United States
Kaiser Permaente
Vallejo California, 94589, United States
Wellness Hematology Oncology
West Hills California, 91307, United States
University of Miami Miller School of Medicine
Deerfield Beach Florida, 33442, United States
Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Memorial Regional Hospital
Hollywood Florida, 33021, United States
Baptist Cancer Institute
Jacksonville Florida, 32207, United States
Florida Cancer Specialists
New Port Richey Florida, 34655, United States
Tallahassee Memorial HealthCare
Tallahassee Florida, 32308, United States
Peachtree Hematology Oncology Consultants, PC
Atlanta Georgia, 30318, United States
Winship Cancer Institute, Emory University
Atlanta Georgia, 30322, United States
Georgia Cancer Specialists Clinic
Atlanta Georgia, 30341, United States
Northwest Georgia Oncology Centers P.C.
Marietta Georgia, 30060, United States
Summit Cancer Care, PC-Savannah
Savannah Georgia, 31405, United States
University of Chicago
Chicago Illinois, 60637, United States
Ingalis Memorial Hospital
Harvey Illinois, 60426, United States
Illinois CancerCare
Peoria Illinois, 60615, United States
Orchard Healthcare Research Inc.
Skokie Illinois, 60077, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Lafayette General Medical Center
Lafayette Louisiana, 70503, United States
Hematology and Oncology Specialists
Marrero Louisiana, 70072, United States
Louisiana State University Health New Orleans
New Orleans Louisiana, 70112, United States
Oschner Medical Center
New Orleans Louisiana, 70121, United States
Anne Arundel Medical Center
Annapolis Maryland, 21401, United States
University of Maryland
Baltimore Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21287, United States
Frederick Memorial Hospital
Frederick Maryland, 21701, United States
Holy Cross Hospital
Silver Spring Maryland, 20902, United States
Virginia Piper Cancer Center
Minneapolis Minnesota, 55407, United States
HCA Midwest Health
Kansas City Missouri, 64132, United States
Washington University Dept of Oncology
Saint Louis Missouri, 63110, United States
St John's Mercy Medical Center
Saint Louis Missouri, 63141, United States
Hunterdon Regional Cancer Center
Flemington New Jersey, 08822, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Clinical Research Alliance, Inc.
Lake Success New York, 11042, United States
ProHEALTH Care Associates
Lake Success New York, 11042, United States
Beth Isreal Medical Center
New York New York, 10011, United States
Weill Cornell Medical Center
New York New York, 10021, United States
Stony Brook University Medical Center
Stony Brook New York, 11794, United States
Novant Health
Charlotte North Carolina, 28204, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Oncology Hematology Care
Cincinnati Ohio, 45242, United States
Cleveland Clinic-Taussig Cancer Institute-R35
Cleveland Ohio, 44195, United States
Signal Point Clinical Research Center, LLC
Middletown Ohio, 45042, United States
Mercy Clinic of Oklahoma
Oklahoma City Oklahoma, 73120, United States
Oregon Health and Science University
Beaverton Oregon, 97006, United States
St Mary Medical Center
Langhorne Pennsylvania, 19047, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Guthrie Clinical Research
Sayre Pennsylvania, 18840, United States
Charleston Hematology Oncology Associates (CHOA)
Charleston South Carolina, 29414, United States
Chattanooga Oncology Hematology Associates
Chattanooga Tennessee, 37404, United States
Center for Biomedical Research, LLC
Knoxville Tennessee, 37909, United States
Sarah Cannon Cancer Center
Nashville Tennessee, 37203, United States
Oncology Hematology Consultants PA
Fort Worth Texas, 76104, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Houston Methodist Cancer Center
Houston Texas, 77030, United States
University of Texas Health Science Center at Houston
Houston Texas, 77030, United States
Texas Tech University Health Sciences Center
Lubbock Texas, 79430, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
St. Vincents Hospital Sydney
Darlinghurst New South Wales, 2010, Australia
Macquarie University
Macquarie Park New South Wales, 2109, Australia
The Tweed Hospital
Tweed Heads New South Wales, 2485, Australia
Sydney Adventist Hospital
Wahroonga New South Wales, 2076, Australia
Townsville Hospital
Douglas Queensland, 4814, Australia
Box Hill Hospital
Box Hill Victoria, 3128, Australia
Western Hospital
Footscray Victoria, 3011, Australia
Joint Ludwig-Austin Dept of Medical Oncology
Heidelberg Victoria, 3084, Australia
Epworth Health Care
Richmond Victoria, 3121, Australia
GasthuisZusters Antwerpen
Wilrijk Antwerpen, 2610, Belgium
Grand Hopital de Charleroi asbl
Charleroi Hainaut, 6000, Belgium
UZ Leuven
Leuven Vlaams Brabant, 3000, Belgium
Clinique Edith Cavell
Brussels Capital Region , 1180, Belgium
Institute Jules Bordet
Bruxelles , 1000, Belgium
Algoma District Cancer Program Sault Area Hospital
Sault Ste Marie Ontario, P6B-0, Canada
Sunnybrook Health Sciences Centre Odette Cancer Center
Toronto Ontario, M4N 3, Canada
St. MIchael's Hospital
Toronto Ontario, M5B 1, Canada
Sir Mortimer B Davis Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Universite de Montreal-Hopital Du Sacre-Coeur De Montreal
Montreal Quebec, H4J 1, Canada
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
Nice Alpes-Maritimes, 06189, France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon Rhône, 69373, France
Centre Jean Bernard Clinique Victor Hugo
Le Mans Sarthe, 72000, France
Institut Sainte Catherine
Avignon , 84000, France
Centre Oscar Lambret
Lille , 59000, France
Hôpital de La Croix Rousse
Lyon , 69317, France
Centre Hospitalier de Mont de Marson - Hôpital Layné
Mont de Marsan , 40000, France
Institut Curie
Paris , 75005, France
Hospices Civils de Lyon
Pierre Benite , 69495, France
Centre Hospitalier Prive Saint-Gregoire
St Gregoire , 35768, France
Klinikum Essingen GmbH
Esslingen Am Neckar Baden-Wurttemberg, 73730, Germany
Helios Klinikum Berlin Buch
Berlin , 13125, Germany
Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide
Cologne , 51067, Germany
Universitätsklinikum Düsseldorf
Düsseldorf , 40225, Germany
Universitätsklinikum Erlangen
Erlangen , 91054, Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main , 65929, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle , 06120, Germany
Universität Des Saarlandes
Homberg , 66421, Germany
Rotkreuzklinikum München
Munich , 80637, Germany
Universitätsklinikum Münster
Münster , 48149, Germany
Hämatologisch-Onkologische Schwerpunktpraxis
Troisdorf , 53840, Germany
Istituto Scientifico romagnolo Per Lo Studio E La Cura Del Tumori IRST
Meldola Emilia-Romagna, 47014, Italy
Fondazione Policlinico Universitario A Gemelli
Roma Lazio, 00168, Italy
Azienda Ospedaliera Fatebenefratelli e Oftaimico
Milano Lombardia, 20121, Italy
Istituto Nazionale Dei Tumori
Milano Lombardia, 20133, Italy
Istituto Europeo Di Oncologia
Milano Lombardia, 20141, Italy
Istituto Clinico Humanitas
Rozzano Lombardia, 20089, Italy
Centro Di Riferimento Oncologico
Aviano Pordenone, 33081, Italy
Azienda Ospedaliera Universitaria Pisana
Pisa Toscana, 56126, Italy
Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi
Bologna , 40138, Italy
Azienda Ospedaliera Citta della Salute e della Scienza de Torino
Torino , 10126, Italy
Hospital Universitario Central de Asturias
Oviedo Asturias, 33011, Spain
Hospital Universitari Germans Trias i Pujol
Badalona Barcelona, 08916, Spain
Corporacio Sanitaria Parc Tauli
Sabadell Barcelona, 08208, Spain
Consorcio Hospitalario Provincial de Castellon
Castellon de La Plana Castellón, 12002, Spain
Hospital Universitario Ramon y Cajal
Madrid Communidad Delaware, 28034, Spain
Hospital Regional Universitario de Malaga - Hospital General
Malaga Málaga, 29011, Spain
Hospital Universitario Vall d'Hebron
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
MD Anderson Cancer Center Madrid-Espana
Madrid , 28033, Spain
Hospital Clinico San Carlos
Madrid , , Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Barts Health NHS Trust
London City Of London, EC1A , United Kingdom
Derriford Hospital
Plymouth Devon, PL6 8, United Kingdom
Royal Sussex County Hospital
Brighton East Sussex, BN2 5, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow Glasgow City, G12 0, United Kingdom
Blackpool Victoria Hospital
Blackpool Lancashire, FY3 8, United Kingdom
University College London
London London, City Of, NW1 2, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham Nottinghamshire, NG5 1, United Kingdom
Sarah Cannon Research Institute UK
City of London , W1G 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

327

Study ID:

NCT01997333

Recruitment Status:

Completed

Sponsor:


Celldex Therapeutics

How clear is this clinincal trial information?

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