529
Participants
Start Date
November 7, 2017
Primary Completion Date
March 30, 2020
Study Completion Date
December 8, 2020
Sacituzumab govitecan
10 mg/kg administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump. Infusion rate for the first 15 minutes will start with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour.
Eribulin
Administered IV over 2 to 5 minutes at a dose 1.4 mg/m\^2 at North American sites and 1.23 mg/m\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses will be administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\^2 and 0.67 mg/m\^2 for North American and European sites, respectively).
Capecitabine
1000 to 1250 mg/m\^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.
Gemcitabine
800 to 1200 mg/m\^2 will be administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.
Vinorelbine
25 mg/m\^2 will be administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine will not be allowed as TPC for any participant with Grade 2 neuropathy.
Institut Jules Bordet, Brussels
Universitair Zlekenhuis Brussel, Brussels
UZ Leuven, Leuven
Clinique et Maternite Sainte-Elisabeth, Namur
Hospital del Mar, Barcelona
Hospital Universitario Vall d'Hebron, Barcelona
Hospital de la Santa Creu i Sant Pau, Carrer del Mas Casanovas, 90, Barcelona
Columbia University Medical Center, New York
Memorial Sloan Kettering Cancer Center, New York
North Shore Hematology Oncology Associates., PC, 235 North Belle Mead Road, East Setauket
North Shore Hematology Oncology Associates., PC, 285 Sills Road Building 16, Patchogue
New York Oncology Hematology, P.C., Clifton Park
New York Oncology Hematology, P.C., Albany
Hospital Teresa Herrera, As Xubias, 84, A Coruña
UPMC Hillman Cancer Center Upper Saint Clair, Pittsburgh
UPMC Hillman Cancer Center UPMC East, Monroeville
Allegheny-Singer Research Institute, 320 East North Avenue, Pittsburgh
Magee-Womens Hospital of UPMC, Pittsburgh
UPMC Hillman Cancer Center UPMC Passavant, Pittsburgh
UPMC Hillman Cancer Center Mountainview Arnold Palmer Pavilion, Greensburg
Complexo Hospitalario Universitario de Santiago (CHUS) - Hospital Clinco Universaitario, Santiago de Compostela
Georgetown Lombardi Comprehensive Cancer Center, Washington D.C.
Virginia Cancer Specialists, PC, Gainesville
Virginia Cancer Specialists, PC, Leesburg
Facharztzentrum Eppendorf, Hamburg
Maryland Oncology Hematology, Brandywine
Maryland Oncology Hematology, Clinton
Maryland Oncology Hematology, Bethesda
Maryland Oncology Hematology, Rockville
Maryland Oncology Hematology, Silver Spring
Maryland Oncology Hematology, Silver Spring
Maryland Oncology Hematology, Columbia
Virginia Cancer Specialists, PC, Woodbridge
Virginia Cancer Specialists, PC, Arlington
Virginia Cancer Specialists, PC, Alexandria
Virginia Oncology Associates, Chesapeake
Virginia Oncology Associates, Virginia Beach
Virginia Oncology Associates, Newport News
Virginia Oncology Associates, Hampton
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Roanoke
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Blacksburg
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Salem
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Wytheville
Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care, Low Moor
CHU Besançon - Hôpital Jean Minjoz, Besançon
Hospital Universitari Arnau de Vilanova de Lleida, Lleida
UNC Health Care System, Chapel Hill
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
West Cancer Center, 7945 Wolf River Blvd, Germantown
Atlanta Cancer Center - Alpharetta, Alpharetta
Atlanta Cancer Care - Decatur, Decatur
GCS/Stemmer, Decatur
Atlanta Cancer Care - Cumming, Cumming
GCS/Kennestone, Marietta
Atlanta Cancer Care - Conyers, Conyers
GCS/Canton, Canton
Atlanta Cancer Care - Stockbridge, Jonesboro
GCS/Annex, Atlanta
Atlanta Cancer Care - Atlanta, Atlanta
Northside Hospital, Atlanta
GCS/Northside, Sandy Springs
University Cancer & Blood Center, 3320 Old Jefferson Rd, Athens
Institut Claudius Regaud, Toulouse
GCS/Macon, Macon
Florida Cancer Specialists & Research Institute, 224 Memorial medical Parway, Daytona Beach
Florida Cancer Specialists & Research Institute, 1400 US highway 441 N, The Villages
Florida Cancer Specialists & Research Institute, 6420 W Newberry Road Est Wing, Gainesville
Florida Cancer Specialists & Research Institute, 601 E. Altamonte Drive, Altamonte Springs
Florida Cancer Specialists & Research Institute, 765 Image Way, Orange City
Florida Cancer Specialists & Research Institute - 325 Clyde Morris, Ormond Beach
Florida Cancer Specialists & Research Institute, 4100 Waterman Way, Tavares
Florida Cancer Specialists & Research Institute, 2100 Glenwood Drive, Winter Park
Florida Cancer Specialists & Research Institute, 70 W Gore Street, Orlando
Florida Cancer Specialists & Research Institute - 3730 7th Terrace, Vero Beach
Sylvester Comprehensive Cancer Center, Miami
Sylvester Comprehensive Cancer Center, Coral Gables
Baptist Health Medical Group Oncology, LLC, Miami
Sylvester Comprehensive Cancer Center, Plantation
Sylvester Comprehensive Cancer Center, Deerfield Beach
Florida Cancer Specialists & Research Institute, 403 S. King Ave, Brandon
Florida Cancer Specialists & Research Institute, 3402 W Dr. Martin Luther King Jr Boulevard, Tampa
Florida Cancer Specialists & Research Institute, 560 Jackson St, St. Petersburg
Florida Cancer Specialists & Research Institute, 3280 McMullen Booth road, Clearwater
Florida Cancer Specialists & Research Institute, 100 Highland Avenue, Largo
Florida Cancer Specialists, Fort Myers
Florida Cancer Specialists, Cape Coral
Florida Cancer Specialists, Port Charlotte
Florida Cancer Specialists, Naples
Florida Cancer Specialist, Bonita Springs
Florida Cancer Specialists, Bradenton
Florida Cancer Specialists, Sarasota
Florida Cancer Specialists, Venice
Florida Cancer Specialists, Venice
Florida Cancer Specialists & Research Institute, 521 N. Lecanto Highway, Lecanto
Florida Cancer Specialists & Research Institute, 1630 SE 18th ST, Ocala
Florida Cancer Specialists & Research Institute, 7154 Medical Center Drive, Spring Hill
Florida Cancer Specialists & Research Institute, 8763 River Crossing Blvd, New Port Richey
Centre Eugène Marquis, Rennes
Southern Cancer Center, 29653 Anchor Cross Blvd, Daphne
Souther Cancer Center, 3719 Dauphin St., 5 Floor, Mobile
Southern Cancer Center, 3 Mobile Infirmary Circle, Mobile
Southern Cancer Center, 6701 Airport Blvd., Bldg B, Terace Level, Mobile
Tennessee Oncology, LLC, Dickson
Tennessee Oncology, LLC, Gallatin
Tennessee Ocology, LLC, Franklin
Tennessee Oncology, LLC, Hermitage
Tennessee Oncology, LLC, Lebanon
Tennessee Oncology, LLC, Murfreesboro
Tennessee Oncology, LLC, Shelbyville
Sarah Cannon Cancer Institute/Tennessee Oncology, Nashville
Tennessee Oncology, LLC, Nashville
Vanderbilt Breast Cancer Center at One Hundred Oaks 719 Thompson Lane, Suite 25000, Nashville
Tennessee Ocology, LLC, Nashville
Tennessee Oncology, LLC, Nashville
Tenessee Oncology, Nashville
Henry-Joyce Cancer Clinic 1301 Medical Center Drive 1903 The Vanderbilt Clinic Nashville, TN 37232, Nashville
Vanderbilt-Ingram Cancer Center, Nashville
Tenesse Oncology - PLLC, Cleveland
Tennesee Oncology - PLLC, Chattanooga
Hospital Universitario Virgen del Rocío, Seville
Praxis für Hämatologie und Internistische Onkologie, Velbert
The Ohio State University Wexner Medical Center, 1145 Olentangy River Road, Columbus
CHU de Nantes - Hôpital Nord Laennec, Saint-Herblain
Centre de Lutte Contre le Cancer - Institut de Cancerologie de l'Ouest - Paul Papin, Angers
Minnesota Oncology Hematology P.A., Minneapolis
Abbot Northwestern Hospital, Minneapolis
Virginia G. Piper Cancer Center at HonorHealth, Minneapolis
Mercy Hospital - Unity Campus AHL, Fridley
Minnesota Oncology Hematology P.A., Fridley
Mercy Hospital, Coon Rapids
Minnesota Oncology Hematology P.A., Coon Rapids
Suburban Imaging Northwest, Coon Rapids
Suburban Imaging, Coon Rapids
Mayo Clinic - 200 First Street SW, Rochester
Institut für Versorgungsforschung in der Onkologie, Koblenz
Illinois Cancer Specialists, Arlington Heights
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus, Frankfurt
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital 1900 Silver Cross Blvd, New Lenox
Orland Park - UCMC Center for Advanced Care 14290 South LaGrange Rd, Orland Park
University of Chicago Medical Center 5841 S. Maryland Ave, Chicago
Washington University School of Medicine in St. Louis, St Louis
Washington University School of Medicine in St. Louis, St Louis
Washington University School of Medicine in St. Louis, St Louis
Washington University School of Medicine in St. Louis, Creve Coeur
MidAmerica Division Inc. c/o Menorah Medical Center, Independence
Research Medical Center, Kansas City
MidAmerica Division Inc. c/o Menorah Medical Center, Overland Park
Nebraska Cancer Specialists - Midwest Cancer Center - Papillion, Omaha
Nebraska Cancer Specialists - Midwest Cancer Center - Paillion, Omaha
Institut Curie, Paris
Texas Oncology-Longview Cancer Center, Longview
US Oncology, Tyler
Center for Cancer and Blood Disorders, Arlington
Center for Cancer and Blood Disorders, Burleson
Center for Cancer and Blood Disorders, Weatherford
Texas Oncology, Denton
Houston Methodist Hospital - 6565 Fannin St, Houston
Praxis für interdisziplinäre Onkologie & Hämatologie GbR, Freiburg im Breisgau
University of Colorado Hospital - Anschutz Cancer Pavilion, 1665 Aurora Court, Aurora
Rocky Mountain Cancer Centers, 499 E Hampden Ave Suite 450, Englewood
Rocky Mountain Cancer Centers, 22 West Dry Creek Circle, Littleton
Rocky Mountain Cancer Centers, 10103 Ridge Gate Parkway, Suite G-01, Lone Tree
Rocky Mountain Cancer Centers, 9397 Crown Crest Blvd., Suite 421, Parker
Rocky Mountain Cancer Centers, 1800 Williams St., Denver
Rocky Mountain Cancer Centers, 4700 E. Hale Parkway, Suite 400, Denver
Rocky Mountain Cancer Centers, 11750 West 2nd Place, Suite 1-100, Lakewood
Rocky Mountain Cancer Centers, 8820 Huron Street, Thornton
Rocky Mountain Cancer Centers, 4715 Arapahoe Ave, Boulder
Rocky Mountain Cancer Centers, 2030 W Mountain View Avenue, Ste. 210, Longmont
Rocky Mountain Cancer Centers, 2312 N. Nevada Avenue, Suite 400, Colorado Springs
Rocky Mountain Cancer Centers, 3676 Parker Blvd., Suite 350, Pueblo
Mayo Clinic Hospital, Phoenix
Mayo Clinic Hospital, Scottsdale
UCLA Jonsson Comprehensive Cancer Center, 200 UCLA Medical Plaza, Los Angeles
UCLA Jonsson Comprehensive Cancer Center, 625 South Fair Oaks Avenue Suite 320, Pasadena
UCLA Jonsson Comprehensive Cancer Center, 201. S. Buena Vista St Suite 200, Burbank
UCLA Jonsson Comprehensive Cancer Center, 1411 S. Garfield Ave Suite 200, Alhambra
Florence Lerebours, Saint-Cloud
UCLA Jonsson Comprehensive Cancer Center, Laguna Hills
University of California, San Francisco (UCSF) - Innovation, Technology & Alliances, 1600 Divisadero Street, San Francisco
UCLA Jonsson Comprehensive Cancer Center, 2020 Santa Monica Boulevard, Santa Monica
Gustave Roussy, Villejuif
Providence Medical Group, Portland
Swedish Cancer Institute, Edmonds
Swedish Cancer Institute, Issaquah
Swedish Cancer Institute, Seattle
Swedish Cancer Institute, Seattle
Florida Cancer Specialists & Research Institute, 1037 State Road 7 Bldg B, Wellington
The Ohio State University Wexner Medical Center, 460 W 10th Ave, Columbus
Rocky Mountain Cancer Centers, 1700 South Potomac Street, Aurora
Yale School Of Medicine, New Haven
Norwalk Hospital, 34 Maple Street, Norwalk
Orlando Regional Medical Center, Orlando
Florida Cancer Specialists & Research Institute, 1201 Fifth Avenue North, St. Petersburg
Florida Cancer Specialists & Research Institute1309 N Flagler Dr, West Palm Beach
Illinois Cancer Specialists, Niles
University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion, Westwood
Dana-Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
Beth Israel Deaconess Medical Center (BIDMC), Boston
Mass General - North Shore Cancer Center ( NSCC ), Danvers
Nebraska Cancer Specialists- Midwest Cancer Center- Papillion, Papillion
Rutgers Cancer Institute of New Jersey, New Brunswick
Tennessee Oncology - Chattanooga Oncology & Hematology Associates, Chattanooga
Texas Oncology- Medical City Dallas Building D, Dallas
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas
Center for Cancer and Blood Disorders, Fort Worth
Texas Oncology, Plano
Virginia Cancer Specialists, PC, Fairfax
Virginia Oncology Associates, P.C., Norfolk
Cross Cancer Institute, 11560 University Avenue, Edmonton
Queen Elizabeth II Health Sciences Centre, Halifax
Sunnybrook Health Sciences Centre, Toronto
Jewish General Hospital, 3755 Côte-Sainte-Catherine, Montreal
Jewish General Hospital, 3755 Côte-Sainte-Catherine, Québec
Institut Régional du Cancer de Montpellier, Montpellier
Hospital Quirón Barcelona, Plaza Alfonso Comín 5, Barcelona
Institut Catala d'Oncologia Hospitalet, Avenida Gran Via 199-203, L'Hospitalet de Llobregat
Colchester Hospital University NHS Foundation Trust - Colchester General Hospital, Turner Road, Colchester
The Arden Cancer Centre- University Hospital Coventry, Coventry
County Durham and Darlington NHS Foundation Trust - University Hospital of North Durham, Durham
The Royal Surrey County Hospital NHS Foundation Trust, Guildford
The County Hospital, Wye Valley NHS Trust, Hereford
The Royal Free London NHS Foundation Trust - The Royal Free Hospital, Pond Street Oncology & Haematology Clinical Trials Unit Dept. of Academic Oncology, London
The Christie NHS Foundation Trust, Manchester
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham
Plymouth Hospitals NHS Trust - Derriford Hospital, Plymouth
Taunton and Somerset NHS Foundation Trust - Musgrove Park Hospital, Musgrove Park Hospital, Taunton
The Mid Yorkshire Hospitals NHS Trust - Pinderfields Hospital, Wakefield
Lead Sponsor
Gilead Sciences
INDUSTRY