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

NCT ID: NCT01997333

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 327 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2018-08-07

Brief 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.

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 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.

Conditions

Metastatic gpNMB Over-expressing Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Capecitabine

Capecitabine will be administered on Days 1 through 14 of each 21 day cycle.

Group Type: ACTIVE_COMPARATOR

Capecitabine

Intervention Type: DRUG

Drug: CDX-011

CDX-011 administered as an intravenous infusion on Day 1 of each 21 day cycle.

Group Type: EXPERIMENTAL

CDX-011

Intervention Type: DRUG

Interventions

CDX-011

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

1. 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

2. Documented progression of disease based on radiographic, clinical or pathologic assessment during or subsequent to the last anticancer regimen received.

3. 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.

4. Received no more than two prior chemotherapy treatments for advanced (locally advanced/recurrent or metastatic) breast cancer.

5. Prior chemotherapy treatment must have contained an anthracycline (e.g. doxorubicin or Doxil) if clinically indicated and a taxane (eg: Taxol).

6. ECOG performance status of 0 - 1.

7. 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:

1. Progression/recurrence of breast cancer during or within 3 months of completion of neoadjuvant or adjuvant chemotherapy.

2. Ongoing neuropathy or other chemotherapy or radiation-related toxicities that are moderate (Grade 2) or worse in severity.

3. Known brain metastases, unless previously treated and asymptomatic for 2 months and not progressive in size or number for 2 months.

4. Significant cardiovascular disease.

5. Previously received capecitabine and discontinued due to progression or intolerance; previously received CDX-011 or other MMAE containing agents.

6. Active systemic infection requiring treatment. Infection controlled by oral therapy will not be exclusionary.

7. Chronic use of systemic corticosteroids.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celldex Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universität Des Saarlandes

Homberg (Efze), , Germany

Rotkreuzklinikum München

Munich, , Germany

Universitätsklinikum Münster

Münster, , Germany

Alabama Oncology

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of South Alabama Cancer Research Insititute

Mobile, Alabama, United States

Arizona Cancer Research Alliance

Glendale, Arizona, United States

Arizona Cancer Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Compassionate Care Research Group

Fountain Valley, California, United States

St. Jude Heritage Medical Group

Fullerton, California, United States

USC Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Pacific Cancer Care

Salinas, California, United States

University of California San Francisco

San Francisco, California, United States

Kaiser Permaente

Vallejo, California, United States

Wellness Hematology Oncology

West Hills, California, United States

University of Miami Miller School of Medicine

Deerfield Beach, Florida, United States

Florida Cancer Specialists South

Fort Myers, Florida, United States

Memorial Regional Hospital

Hollywood, Florida, United States

Baptist Cancer Institute

Jacksonville, Florida, United States

Florida Cancer Specialists

New Port Richey, Florida, United States

Tallahassee Memorial HealthCare

Tallahassee, Florida, United States

Peachtree Hematology Oncology Consultants, PC

Atlanta, Georgia, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Georgia Cancer Specialists Clinic

Atlanta, Georgia, United States

Northwest Georgia Oncology Centers P.C.

Marietta, Georgia, United States

Summit Cancer Care, PC-Savannah

Savannah, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Ingalis Memorial Hospital

Harvey, Illinois, United States

Illinois CancerCare

Peoria, Illinois, United States

Orchard Healthcare Research Inc.

Skokie, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Lafayette General Medical Center

Lafayette, Louisiana, United States

Hematology and Oncology Specialists

Marrero, Louisiana, United States

Louisiana State University Health New Orleans

New Orleans, Louisiana, United States

Oschner Medical Center

New Orleans, Louisiana, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

University of Maryland

Baltimore, Maryland, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Frederick Memorial Hospital

Frederick, Maryland, United States

Holy Cross Hospital

Silver Spring, Maryland, United States

Virginia Piper Cancer Center

Minneapolis, Minnesota, United States

HCA Midwest Health

Kansas City, Missouri, United States

Washington University Dept of Oncology

St Louis, Missouri, United States

St John's Mercy Medical Center

St Louis, Missouri, United States

Hunterdon Regional Cancer Center

Flemington, New Jersey, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Clinical Research Alliance, Inc.

Lake Success, New York, United States

ProHEALTH Care Associates

Lake Success, New York, United States

Beth Isreal Medical Center

New York, New York, United States

Weill Cornell Medical Center

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Novant Health

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

Cleveland Clinic-Taussig Cancer Institute-R35

Cleveland, Ohio, United States

Signal Point Clinical Research Center, LLC

Middletown, Ohio, United States

Mercy Clinic of Oklahoma

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Beaverton, Oregon, United States

St Mary Medical Center

Langhorne, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Guthrie Clinical Research

Sayre, Pennsylvania, United States

Charleston Hematology Oncology Associates (CHOA)

Charleston, South Carolina, United States

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, United States

Center for Biomedical Research, LLC

Knoxville, Tennessee, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Oncology Hematology Consultants PA

Fort Worth, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist Cancer Center

Houston, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Texas Tech University Health Sciences Center

Lubbock, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

St. Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia

Macquarie University

Macquarie Park, New South Wales, Australia

The Tweed Hospital

Tweed Heads, New South Wales, Australia

Sydney Adventist Hospital

Wahroonga, New South Wales, Australia

Townsville Hospital

Douglas, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Western Hospital

Footscray, Victoria, Australia

Joint Ludwig-Austin Dept of Medical Oncology

Heidelberg, Victoria, Australia

Epworth Health Care

Richmond, Victoria, Australia

GasthuisZusters Antwerpen

Wilrijk, Antwerpen, Belgium

Grand Hopital de Charleroi asbl

Charleroi, Hainaut, Belgium

UZ Leuven

Leuven, Vlaams Brabant, Belgium

Institute Jules Bordet

Brussels, , Belgium

Clinique Edith Cavell

Brussels Capital Region, , Belgium

Algoma District Cancer Program Sault Area Hospital

Sault Ste. Marie, Ontario, Canada

Sunnybrook Health Sciences Centre Odette Cancer Center

Toronto, Ontario, Canada

St. MIchael's Hospital

Toronto, Ontario, Canada

Sir Mortimer B Davis Jewish General Hospital

Montreal, Quebec, Canada

Universite de Montreal-Hopital Du Sacre-Coeur De Montreal

Montreal, Quebec, Canada

Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

Nice, Alpes-Maritimes, France

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

Lyon, Rhône, France

Centre Jean Bernard Clinique Victor Hugo

Le Mans, Sarthe, France

Institut Sainte Catherine

Avignon, , France

Centre Oscar Lambret

Lille, , France

Hôpital de La Croix Rousse

Lyon, , France

Centre Hospitalier de Mont de Marson - Hôpital Layné

Mont-de-Marsan, , France

Institut Curie

Paris, , France

Hospices Civils de Lyon

Pierre-Bénite, , France

Centre Hospitalier Prive Saint-Gregoire

Saint-Grégoire, , France

Klinikum Essingen GmbH

Esslingen am Neckar, Baden-Wurttemberg, Germany

Helios Klinikum Berlin Buch

Berlin, , Germany

Kliniken der Stadt Koeln gGmbH - Krankenhaus Holweide

Cologne, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Universitätsklinikum Erlangen

Erlangen, , Germany

Klinikum Frankfurt Höchst GmbH

Frankfurt am Main, , Germany

Martin-Luther-Universität Halle-Wittenberg

Halle, , Germany

Hämatologisch-Onkologische Schwerpunktpraxis

Troisdorf, , Germany

Istituto Scientifico romagnolo Per Lo Studio E La Cura Del Tumori IRST

Meldola, Emilia-Romagna, Italy

Fondazione Policlinico Universitario A Gemelli

Rome, Lazio, Italy

Azienda Ospedaliera Fatebenefratelli e Oftaimico

Milan, Lombardy, Italy

Istituto Nazionale Dei Tumori

Milan, Lombardy, Italy

Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Centro Di Riferimento Oncologico

Aviano, Pordenone, Italy

Azienda Ospedaliera Universitaria Pisana

Pisa, Tuscany, Italy

Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

Bologna, , Italy

Azienda Ospedaliera Citta della Salute e della Scienza de Torino

Torino, , Italy

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, Spain

Consorcio Hospitalario Provincial de Castellon

Castellon, Castellón, Spain

Hospital Universitario Ramon y Cajal

Madrid, Communidad Delaware, Spain

Hospital Regional Universitario de Malaga - Hospital General

Málaga, Málaga, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital Clinic de Barcelona

Barcelona, , Spain

MD Anderson Cancer Center Madrid-Espana

Madrid, , Spain

Hospital Clinico San Carlos

Madrid, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Barts Health NHS Trust

London, City of London, United Kingdom

Derriford Hospital

Plymouth, Devon, United Kingdom

Royal Sussex County Hospital

Brighton, East Sussex, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, Glasgow City, United Kingdom

Blackpool Victoria Hospital

Blackpool, Lancashire, United Kingdom

University College London

London, London, City of, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Sarah Cannon Research Institute UK

City of London, , United Kingdom

Countries

United States; Australia; Belgium; Canada; France; Germany; Italy; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CDX011-04

Identifier Type: -

Identifier Source: org_study_id