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Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
Sponsor: Alaunos Therapeutics
Summary
This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).
Official title: A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
447
Start Date
2010-08-16
Completion Date
2013-03-13
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Palifosfamide-Tris
palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles. doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles.
doxorubicin
doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles.
Placebo
placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles.
Locations (161)
Birmingham, Alabama, United States
Arizona Oncology Associates
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
University of California, Los Angeles
Los Angeles, California, United States
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Pomona, California, United States
Sarcoma Oncology Center
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Medical Oncology Hematology Consultants
Newark, Delaware, United States
MedStar Research Institute
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Emory
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Chicago, Illinois, United States
Park Ridge, Illinois, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Kansas City Cancer Center
Overland Park, Kansas, United States
New Orleans, Louisiana, United States
LSU Health Sciences Center, Feist-Weiller Cancer Center
Shreveport, Louisiana, United States
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
St.Louis University
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Hackensack, New Jersey, United States
Morristown, New Jersey, United States
Saint Barnabas
West Orange, New Jersey, United States
Albuquerque, New Mexico, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Summa Health System
Akron, Ohio, United States
UC Cancer Institute
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Pennsylvania Oncology/Hematology Associates
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Charleston, South Carolina, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Texas Oncology
Bedford, Texas, United States
Texas Oncology - Medical City Dallas
Dallas, Texas, United States
Cancer Therapy and Research Center
San Antonio, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States
Bellin Cancer Center
Green Bay, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Milwaukee, Wisconsin, United States
Ciudad de Buenos Aires, Argentina
Córdoba, Argentina
Ramos Mejía, Argentina
Instituto CAICI
Rosario, Argentina
Sante Fe, Argentina
North Adelaide Oncology
Adelaide, Australia
Royal Adelaide Hospital
Adelaide, Australia
Camperdown, Australia
East Melbourne, Australia
The Canberra Hospital
Garran, Australia
Garran, Australia
Kurralta Park, Australia
Nedlands, Australia
Prince of Wales Hospital
Randwick, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Antwerp, Belgium
Brussels, Belgium
Leuven, Belgium
Liège, Belgium
Institution name: Hospital de Câncer de Barretos - Fundação PIOXII
Barretos, Brazil
Belo Horizonte, Brazil
Santa Casa da Misericórdia de Curitiba
Curitiba, Brazil
Florianópolis, Brazil
Jaú, Brazil
Hospital da Cidade de Passo Fundo
Passo Fundo, Brazil
Hospital das Clínicas de Porto Alegre
Porto Alegre, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil
Centro de Oncologia da Bahia
Salvador, Brazil
São Paulo, Brazil
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Santiago, Chile
Instituto Clínico Oncológico del Sur
Temuco, Chile
Viña del Mar, Chile
Bogotá, Colombia
Medellín, Colombia
Montería, Colombia
Angers, France
Bordeaux, France
Institut Paoli Calmettes
Marseille, France
Marseille, France
Montpellier, France
Nice, France
Paris, France
Toulouse, France
Villejuif, France
HELIOS Klinikum Berlin Buch
Bad Sarrow, Germany
Universitätsklinikum Köln
Cologne, Germany
Hanover, Germany
Mannheim, Germany
Tuebingen University Hospital
Tübingen, Germany
Guatemala City, Guatemala
Jaipur, India
Mumbai, India
Nashik, India
Pune, India
Secunderabad, India
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Jerusalem, Israel
Petah Tikva, Israel
Ramat Gan, Israel
Tel Aviv, Israel
Candiolo, Italy
Humanitas Cancer Center
Rozzana, Italy
Ospedale Gradenigo Oncology
Torino, Italy
Centro Hemato Oncologico Paitilla
Panama City, Panama
Medical and Research Center
Panama City, Panama
Wojewodzkie Centrum Onkologii
Gdansk, Poland
Gilwice, Poland
Centrum Onkologii Instytut
Warsaw, Poland
Bucharest, Romania
Cluj-Napoca, Romania
Craiova, Romania
Moscow, Russia
Obninsk, Russia
Saint Petersburg, Russia
Yaroslavl, Russia
Singapore, Singapore
Badalona, Spain
Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Valencia, Spain
The Royal Marsden NHS Foundation Trust Sarcoma
London, United Kingdom
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom