Spots Global Cancer Trial Database for A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
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Trial Identification
Brief Title: A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Official Title: A Randomized Phase 3, Multicenter, Open-Label Study Comparing TH-302 in Combination With Doxorubicin vs. Doxorubicin Alone in Subjects With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma
Study ID: NCT01440088
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether TH-302 in combination with Doxorubicin is safe and effective in the treatment of Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma.
Detailed Description: TH-302 is designed to target the hypoxic regions of tumors which are generally located distant from tumor vessels. Doxorubicin has poor tissue penetration and targets the regions of tumors that are located in proximity to the tumor vessels. The presence of hypoxia in solid tumors is associated with a more malignant phenotype and resistance to chemotherapy. The hypoxia-activated prodrug, TH-302, is designed to selectively target the hypoxic microenvironment. Soft tissue sarcomas have evidence supporting the presence of hypoxia based on pO2 histography, F-MISO and gene expression profiling. There is an absence of therapeutic options for subjects with soft tissue sarcoma. Combining doxorubicin with TH-302 may enable the targeting of both the normoxic and hypoxic regions of soft tissue sarcoma.
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Arizona, Scottsdale, Arizona, United States
Arizona Cancer Center, Tucson, Arizona, United States
USC-Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California, Los Angeles, Los Angeles, California, United States
Sarcoma Oncology Center, Santa Monica, California, United States
Stanford Comprehensive Cancer Center, Stanford, California, United States
Georgetown University Hospital, Washington, District of Columbia, United States
Washington Cancer Institute, Washington, District of Columbia, United States
South Florida Center for Gynecologic Oncology, Boca Raton, Florida, United States
Mayo Clinic-Florida-Cancer Clinical Studies Unit, Jacksonville, Florida, United States
MD Anderson Cancer Center Orlando, Orlando, Florida, United States
H.Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Midtown Campus, Atlanta, Georgia, United States
Kootenai Health - Kootenai Cancer Center, Coeur d'Alene, Idaho, United States
Northwestern University, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Oncology Specialists, Park Ridge, Illinois, United States
Indiana University Simon Cancer Center, Indianapolis, Indiana, United States
University of Iowa Health Care - University of Iowa Hospital, Iowa City, Iowa, United States
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore, Maryland, United States
Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology, Boston, Massachusetts, United States
University of Michigan Cancer Center, Ann Arbor, Michigan, United States
Mayo Rochester, Rochester, Minnesota, United States
Washington University School of Medicine, St. Louis, Missouri, United States
Montefiore, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Columbia University Medical Center, NY, New York, United States
Carolinas Hematology-oncology Associates-Blumenthal Cancer Center, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Wake Forest University Baptist Medical Center, Winston Salem, North Carolina, United States
University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Pennsylvania Oncology Hematology Associates, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
University of Pittsburg Medical Center, Pittsburg, Pennsylvania, United States
MUSC - Hollings Cancer Center, Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
University of Vermont, Burlington, Vermont, United States
Virginia Commonwealth Universtiy-Massey Cancer Center, Richmond, Virginia, United States
University of Washington Cancer Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
University Klinikum Graz, Graz, , Austria
Univ. Klinik fur Innere Medizin I Internistische Onkologie Medizinische Universitat Innsbruck, Innsbruck, , Austria
Allgemeines Krankenhaus Wien, Wien, , Austria
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg, Leuven, , Belgium
Juravinski Cancer Centre at Hamilton Health Sciences - Department of Medicine, Hamilton, Ontario, Canada
McGill University Health Centre, Montreal, Quebec, Canada
Tom Baker Cancer Centre, Calgary, , Canada
Cross Cancer Institute, Edmonton, , Canada
Ottawa Health Research Institue, Ottawa, , Canada
BCCA- Vancouver Cancer Centre - Division of Medical Oncology, Vancouver, , Canada
Cancer Care Manitoba, Winnipeg, , Canada
University Hospital Herlev at Copenhagen, Herlev, Copenhagen, Denmark
ICO Rene Gauducheau, Saint Herblain Cedex, Nantes, France
Institut Bergonie, Bordeaux, , France
Departement d'Oncologie Medicale, Dijon, , France
Centre Leon Berard, Lyon, , France
Département d'Oncologie Moléculaire, Institut Paoli-Calmettes (IPC) and U119 Inserm, Marseille, , France
Centre Antoine Lacassagne, Nice, , France
CHU Strasbourg, Strasbourg, , France
Institut Claudius Regaud, Toulouse Cedex, , France
HELIOS Klinikum Berlin-Buch, Berlin, , Germany
Helios Klinikum Bad Saarow, Department of Hematology, Oncology, and Palliative Care, Sarcoma Center Berlin-Brandenburg, Berlin, , Germany
Universitätsklinikum Essen, Essen, , Germany
Krankenhaus Nordwest GmbH, Frankfurt, , Germany
Medizinische Hochschule Hannover (MHH) - Klinik fuer Haemonstaseologie, Onkologie und Stammzelltransplantation, Hannover, , Germany
Div. of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, Mannheim, , Germany
Wilhelm's University, Universitatsklinikum Muenster, Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1, Munster, , Germany
Magyar Honvedseg Honvedkorhaz, Onkologiai Osztaly, Budapest, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Megyei Onkologiai Kozpont, Szolnok, , Hungary
Sharette Institute of Oncology, Hadassah-Hebrew University Medical Center, Hadassah Medical Org-Ein Karem, Kiryat Hadassah, Jerusalem, Israel
IRCCS Centro di Riferimento Oncologico-Struttura Operativa, Aviano, Pordenone, Italy
Fondazione del Piemonte per l'Oncologia, Instituto per la Ricerca e la Cura del cancro (I.R.C.C.), Dipartimento Oncologico, Direzione Operativa Oncologia Medica a Direzione Universitaria, Candiolo, Torino, Italy
Centro di Riferimento Oncologico (CRO), Aviano, , Italy
Azienda Ospedaliera Garibaldi, Catania, , Italy
Azienda Ospedaliero Universitaria-Policlinico Paolo Giacco, Palermo, , Italy
ASL TO/2 di TORINO_Presidio Sanitario Gradenigo, S.C. di Oncologia, Torino, , Italy
Wojewodzkie Centrum Onkologii, Gdansk, , Poland
Centrum Onkologii Instytut im M. Sklodowskiej-Curie, Krakow, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Warszawa, , Poland
GUZ "Regional Oncology Dispensay", Kazan, Kazan, , Russian Federation
ROTSN RAMS them. Н.Н.Блохина NN Blokhin, Moscow, , Russian Federation
FGU Moscow Research Institute of Oncology named after P.A. Hertzen of Rosmedtechnology, Moscow, , Russian Federation
H.U. Canarias, Hospital Universitario de Canarias. Servicio de Oncología Médica, Tenerife, Canarias, Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Institut Catala d'Oncologia, Barcelona, , Spain
Hospital Sant Joan de Deu, Department de Oncologia, Barcelona, , Spain
Hospital Universitario Ramón y Cajal., Madrid, , Spain
Universidad Complutense Madrid Facultad de Medicina - Hospital Universitario 12 de Octubre, Servicio de Oncologia Medica Hospital Universitario 12 de Octubre, Madrid, , Spain
Contact Details
Name: William Tap, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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