A Trial of TH-302 in Combination With Doxorubicin Versus Doxorubicin Alone to Treat Patients With Locally Advanced Unresectable or Metastatic Soft Tissue Sarcoma

PHASE3CompletedINTERVENTIONAL
Enrollment

640

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2015

Study Completion Date

May 31, 2016

Conditions
Soft Tissue Sarcoma
Interventions
DRUG

TH-302 in Combination with Doxorubicin

"300 mg/m2 of TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.~Doxorubicin may be delivered as a bolus administration or as a continuous infusion administration; administration schedule must be specified prior to enrollment.~Doxorubicin bolus administration: 75 mg/m2 administered by bolus injection starting on Day 1 of a 21-day cycle.~Doxorubicin continuous administration: 75 mg/m2 administered by continuous IV infusion over 48-96 hours starting on Day 1 of a 21-day cycle.~Doxorubicin administration will start between 2 to 4 hours after completion of the TH-302 infusion when used in combination with TH-302."

DRUG

Doxorubicin

"Doxorubicin may be delivered as a bolus administration or as a continuous infusion administration; administration schedule must be specified prior to enrollment.~Doxorubicin bolus administration: 75 mg/m2 administered by bolus injection starting on Day 1 of a 21-day cycle.~Doxorubicin continuous administration: 75 mg/m2 administered by continuous IV infusion over 48-96 hours starting on Day 1 of a 21-day cycle."

Trial Locations (92)

2730

University Hospital Herlev at Copenhagen, Herlev

3000

Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg, Leuven

10031

Memorial Sloan-Kettering Cancer Center, New York

10032

Columbia University Medical Center, New York

10060

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

10149

ASL TO/2 di TORINO_Presidio Sanitario Gradenigo, S.C. di Oncologia, Torino

10461

Montefiore, The Bronx

13009

Département d'Oncologie Moléculaire, Institut Paoli-Calmettes (IPC) and U119 Inserm, Marseille

13125

HELIOS Klinikum Berlin-Buch, Berlin

14263

Roswell Park Cancer Institute, Buffalo

15232

University of Pittsburg Medical Center, Pittsburgh

15526

Helios Klinikum Bad Saarow, Department of Hematology, Oncology, and Palliative Care, Sarcoma Center Berlin-Brandenburg, Berlin

19106

Pennsylvania Oncology Hematology Associates, Philadelphia

19111

Fox Chase Cancer Center, Philadelphia

20007

Georgetown University Hospital, Washington D.C.

20010

Washington Cancer Institute, Washington D.C.

21079

Departement d'Oncologie Medicale, Dijon

21287

Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital, Baltimore

23298

Virginia Commonwealth Universtiy-Massey Cancer Center, Richmond

27157

Wake Forest University Baptist Medical Center, Winston-Salem

27710

Duke University Medical Center, Durham

28034

Hospital Universitario Ramón y Cajal., Madrid

Universidad Complutense Madrid Facultad de Medicina - Hospital Universitario 12 de Octubre, Servicio de Oncologia Medica Hospital Universitario 12 de Octubre, Madrid

28203

Carolinas Hematology-oncology Associates-Blumenthal Cancer Center, Charlotte

29425

MUSC - Hollings Cancer Center, Charleston

30322

Winship Cancer Institute of Emory University, Midtown Campus, Atlanta

30625

Medizinische Hochschule Hannover (MHH) - Klinik fuer Haemonstaseologie, Onkologie und Stammzelltransplantation, Hanover

31052

Institut Claudius Regaud, Toulouse

32224

Mayo Clinic-Florida-Cancer Clinical Studies Unit, Jacksonville

32806

MD Anderson Cancer Center Orlando, Orlando

33076

Institut Bergonie, Bordeaux

33081

IRCCS Centro di Riferimento Oncologico-Struttura Operativa, Aviano

Centro di Riferimento Oncologico (CRO), Aviano

33487

South Florida Center for Gynecologic Oncology, Boca Raton

33612

H.Lee Moffitt Cancer Center and Research Institute, Tampa

37232

Vanderbilt-Ingram Cancer Center, Nashville

38320

H.U. Canarias, Hospital Universitario de Canarias. Servicio de Oncología Médica, Santa Cruz de Tenerife

43202

The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center, Columbus

44106

University Hospitals Seidman Cancer Center, Cleveland

44195

Cleveland Clinic Foundation, Cleveland

44805

ICO Rene Gauducheau, Saint-Herblain

45122

Universitätsklinikum Essen, Essen

46202

Indiana University Simon Cancer Center, Indianapolis

48109

University of Michigan Cancer Center, Ann Arbor

48149

Wilhelm's University, Universitatsklinikum Muenster, Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1, Münster

52242

University of Iowa Health Care - University of Iowa Hospital, Iowa City

53226

Medical College of Wisconsin, Milwaukee

55905

Mayo Rochester, Rochester

60068

Oncology Specialists, Park Ridge

60611

Northwestern University, Chicago

60612

Rush University Medical Center, Chicago

63110

Washington University School of Medicine, St Louis

67098

CHU Strasbourg, Strasbourg

69008

Centre Leon Berard, Lyon

83814

Kootenai Health - Kootenai Cancer Center, Coeur d'Alene

85259

Mayo Arizona, Scottsdale

85719

Arizona Cancer Center, Tucson

90033

USC-Norris Comprehensive Cancer Center, Los Angeles

90127

Azienda Ospedaliero Universitaria-Policlinico Paolo Giacco, Palermo

90403

Sarcoma Oncology Center, Santa Monica

91120

Sharette Institute of Oncology, Hadassah-Hebrew University Medical Center, Hadassah Medical Org-Ein Karem, Kiryat Hadassah

94305

Stanford Comprehensive Cancer Center, Stanford

95122

Azienda Ospedaliera Garibaldi, Catania

97239

Oregon Health and Science University, Portland

98109

University of Washington Cancer Center, Seattle

115478

ROTSN RAMS them. Н.Н.Блохина NN Blokhin, Moscow

125284

FGU Moscow Research Institute of Oncology named after P.A. Hertzen of Rosmedtechnology, Moscow

420029

"GUZ Regional Oncology Dispensay, Kazan", Kazan'

90095-6901

University of California, Los Angeles, Los Angeles

02215

Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology, Boston

05405

University of Vermont, Burlington

A-8036

University Klinikum Graz, Graz

A-6020

Univ. Klinik fur Innere Medizin I Internistische Onkologie Medizinische Universitat Innsbruck, Innsbruck

A-1090

Allgemeines Krankenhaus Wien, Vienna

L8V5C2

Juravinski Cancer Centre at Hamilton Health Sciences - Department of Medicine, Hamilton

H3G 1A4

McGill University Health Centre, Montreal

T2N4N2

Tom Baker Cancer Centre, Calgary

T6G1Z2

Cross Cancer Institute, Edmonton

K1H8L6

Ottawa Health Research Institue, Ottawa

V5Z4E6

BCCA- Vancouver Cancer Centre - Division of Medical Oncology, Vancouver

R3E0V9

Cancer Care Manitoba, Winnipeg

Unknown

Centre Antoine Lacassagne, Nice

Krankenhaus Nordwest GmbH, Frankfurt

D-68165

Div. of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, Mannheim

H-1062

Magyar Honvedseg Honvedkorhaz, Onkologiai Osztaly, Budapest

H-5004

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Megyei Onkologiai Kozpont, Szolnok

80-219

Wojewodzkie Centrum Onkologii, Gdansk

31-115

Centrum Onkologii Instytut im M. Sklodowskiej-Curie, Krakow

02-781

Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Warsaw

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

08907

Institut Catala d'Oncologia, Barcelona

08950

Hospital Sant Joan de Deu, Department de Oncologia, Barcelona

Sponsors
All Listed Sponsors
collaborator

Sarcoma Alliance for Research through Collaboration (SARC)

UNKNOWN

lead

Threshold Pharmaceuticals

INDUSTRY