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

Primary Purpose

Soft Tissue Sarcoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TH-302 in Combination with Doxorubicin
Doxorubicin
Sponsored by
Threshold Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring TH-302, TH-CR-406, SARC021, Locally Advanced Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma, Sarcoma, Doxorubicin, Evofosfamide

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female ≥ 15 years of age
  • Ability to understand the purposes and risks of the study and has signed or, if appropriate, the subject's parent or legal guardian has signed a written informed consent form approved by the investigator's IRB/Ethics Committee

  • Pathologically confirmed diagnosis of soft tissue sarcoma of the following histopathologic types:

    • Synovial sarcoma
    • High grade fibrosarcoma
    • Undifferentiated sarcoma; sarcoma not otherwise specified (NOS)
    • Liposarcoma
    • Leiomyosarcoma (excluding GIST)
    • Angiosarcoma (excluding Kaposi's sarcoma)
    • Malignant peripheral nerve sheath tumor
    • Pleomorphic Rhabdomyosarcoma
    • Myxofibrosarcoma
    • Epithelioid sarcoma
    • Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (MFH) (including pleomorphic, giant cell, myxoid and inflammatory forms)
  • Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate.
  • Recovered from reversible toxicities of prior therapy
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months
  • Acceptable liver, renal, hematological and cardiac function
  • All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception

Exclusion Criteria:

  • Prior systemic therapy for advanced or metastatic disease (neoadjuvant therapy followed by surgical resection and adjuvant therapy permitted). Palliative radiotherapy to non-target lesions is allowed if completed at least two weeks prior to study entry
  • Low grade tumors according to standard grading systems
  • Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards
  • Prior therapy with an anthracycline or anthracenedione
  • Prior mediastinal/cardiac radiotherapy
  • Current use of drugs with known cardiotoxicity or known interactions with doxorubicin
  • Anti-cancer treatment with radiation therapy, neoadjuvant or adjuvant chemotherapy, targeted therapies, immunotherapy, hormones or other antitumor therapies within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Palliative radiotherapy to non-target lesions is allowed, is completed at least two weeks prior to study entry.
  • Significant cardiac dysfunction precluding treatment with doxorubicin
  • Seizure disorders requiring anticonvulsant therapy unless seizure-free for the last year
  • Known brain metastases (unless previously treated and well controlled for a period of ≥ 3 months)
  • Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years
  • Severe chronic obstructive or other pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Prior therapy with a hypoxic cytotoxin
  • Subjects who participated in an investigational drug or device study within 28 days prior to study entry
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Subjects who have exhibited allergic reactions to a structural compound similar to TH-302,doxorubicin or their excipients
  • Females who are pregnant or breast-feeding
  • Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
  • Unwillingness or inability to comply with the study protocol for any reason

Sites / Locations

  • Mayo Arizona
  • Arizona Cancer Center
  • USC-Norris Comprehensive Cancer Center
  • University of California, Los Angeles
  • Sarcoma Oncology Center
  • Stanford Comprehensive Cancer Center
  • Georgetown University Hospital
  • Washington Cancer Institute
  • South Florida Center for Gynecologic Oncology
  • Mayo Clinic-Florida-Cancer Clinical Studies Unit
  • MD Anderson Cancer Center Orlando
  • H.Lee Moffitt Cancer Center and Research Institute
  • Winship Cancer Institute of Emory University, Midtown Campus
  • Kootenai Health - Kootenai Cancer Center
  • Northwestern University
  • Rush University Medical Center
  • Oncology Specialists
  • Indiana University Simon Cancer Center
  • University of Iowa Health Care - University of Iowa Hospital
  • Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital
  • Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology
  • University of Michigan Cancer Center
  • Mayo Rochester
  • Washington University School of Medicine
  • Montefiore
  • Roswell Park Cancer Institute
  • Memorial Sloan-Kettering Cancer Center
  • Columbia University Medical Center
  • Carolinas Hematology-oncology Associates-Blumenthal Cancer Center
  • Duke University Medical Center
  • Wake Forest University Baptist Medical Center
  • University Hospitals Seidman Cancer Center
  • Cleveland Clinic Foundation
  • The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center
  • Oregon Health and Science University
  • Pennsylvania Oncology Hematology Associates
  • Fox Chase Cancer Center
  • University of Pittsburg Medical Center
  • MUSC - Hollings Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • University of Vermont
  • Virginia Commonwealth Universtiy-Massey Cancer Center
  • University of Washington Cancer Center
  • Medical College of Wisconsin
  • University Klinikum Graz
  • Univ. Klinik fur Innere Medizin I Internistische Onkologie Medizinische Universitat Innsbruck
  • Allgemeines Krankenhaus Wien
  • Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
  • Juravinski Cancer Centre at Hamilton Health Sciences - Department of Medicine
  • McGill University Health Centre
  • Tom Baker Cancer Centre
  • Cross Cancer Institute
  • Ottawa Health Research Institue
  • BCCA- Vancouver Cancer Centre - Division of Medical Oncology
  • Cancer Care Manitoba
  • University Hospital Herlev at Copenhagen
  • ICO Rene Gauducheau
  • Institut Bergonie
  • Departement d'Oncologie Medicale
  • Centre Leon Berard
  • Département d'Oncologie Moléculaire, Institut Paoli-Calmettes (IPC) and U119 Inserm
  • Centre Antoine Lacassagne
  • CHU Strasbourg
  • Institut Claudius Regaud
  • HELIOS Klinikum Berlin-Buch
  • Helios Klinikum Bad Saarow, Department of Hematology, Oncology, and Palliative Care, Sarcoma Center Berlin-Brandenburg
  • Universitätsklinikum Essen
  • Krankenhaus Nordwest GmbH
  • Medizinische Hochschule Hannover (MHH) - Klinik fuer Haemonstaseologie, Onkologie und Stammzelltransplantation
  • Div. of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center
  • Wilhelm's University, Universitatsklinikum Muenster, Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1
  • Magyar Honvedseg Honvedkorhaz, Onkologiai Osztaly
  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Megyei Onkologiai Kozpont
  • Sharette Institute of Oncology, Hadassah-Hebrew University Medical Center, Hadassah Medical Org-Ein Karem
  • IRCCS Centro di Riferimento Oncologico-Struttura Operativa
  • 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
  • Centro di Riferimento Oncologico (CRO)
  • Azienda Ospedaliera Garibaldi
  • Azienda Ospedaliero Universitaria-Policlinico Paolo Giacco
  • ASL TO/2 di TORINO_Presidio Sanitario Gradenigo, S.C. di Oncologia
  • Wojewodzkie Centrum Onkologii
  • Centrum Onkologii Instytut im M. Sklodowskiej-Curie
  • Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
  • GUZ "Regional Oncology Dispensay", Kazan
  • ROTSN RAMS them. Н.Н.Блохина NN Blokhin
  • FGU Moscow Research Institute of Oncology named after P.A. Hertzen of Rosmedtechnology
  • H.U. Canarias, Hospital Universitario de Canarias. Servicio de Oncología Médica
  • Hospital de la Santa Creu i Sant Pau
  • Institut Catala d'Oncologia
  • Hospital Sant Joan de Deu, Department de Oncologia
  • Hospital Universitario Ramón y Cajal.
  • Universidad Complutense Madrid Facultad de Medicina - Hospital Universitario 12 de Octubre, Servicio de Oncologia Medica Hospital Universitario 12 de Octubre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TH-302 in Combination with Doxorubicin

Doxorubicin

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of TH-302 in combination with doxorubicin
Efficacy will be determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy compared with doxorubicin alone

Secondary Outcome Measures

Safety of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma compared with doxorubicin alone
To investigate the pharmacokinetics of TH-302, Br-IPM, doxorubicin, and doxorubicinol in plasma

Full Information

First Posted
September 20, 2011
Last Updated
June 1, 2016
Sponsor
Threshold Pharmaceuticals
Collaborators
Sarcoma Alliance for Research through Collaboration (SARC)
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1. Study Identification

Unique Protocol Identification Number
NCT01440088
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Threshold Pharmaceuticals
Collaborators
Sarcoma Alliance for Research through Collaboration (SARC)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
Keywords
TH-302, TH-CR-406, SARC021, Locally Advanced Soft Tissue Sarcoma, Metastatic Soft Tissue Sarcoma, Sarcoma, Doxorubicin, Evofosfamide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TH-302 in Combination with Doxorubicin
Arm Type
Experimental
Arm Title
Doxorubicin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TH-302 in Combination with Doxorubicin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy of TH-302 in combination with doxorubicin
Description
Efficacy will be determined by overall survival in subjects with locally advanced unresectable or metastatic soft tissue sarcoma previously untreated with chemotherapy compared with doxorubicin alone
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety of TH-302 in combination with doxorubicin in subjects with locally advanced unresectable or metastatic soft tissue sarcoma compared with doxorubicin alone
Description
To investigate the pharmacokinetics of TH-302, Br-IPM, doxorubicin, and doxorubicinol in plasma
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥ 15 years of age Ability to understand the purposes and risks of the study and has signed or, if appropriate, the subject's parent or legal guardian has signed a written informed consent form approved by the investigator's IRB/Ethics Committee Pathologically confirmed diagnosis of soft tissue sarcoma of the following histopathologic types: Synovial sarcoma High grade fibrosarcoma Undifferentiated sarcoma; sarcoma not otherwise specified (NOS) Liposarcoma Leiomyosarcoma (excluding GIST) Angiosarcoma (excluding Kaposi's sarcoma) Malignant peripheral nerve sheath tumor Pleomorphic Rhabdomyosarcoma Myxofibrosarcoma Epithelioid sarcoma Undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (MFH) (including pleomorphic, giant cell, myxoid and inflammatory forms) Locally advanced unresectable or metastatic disease with no standard curative therapy available and for whom treatment with single agent doxorubicin is considered appropriate. Recovered from reversible toxicities of prior therapy Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of at least 3 months Acceptable liver, renal, hematological and cardiac function All women of childbearing potential must have a negative serum pregnancy test and all subjects must agree to use effective means of contraception Exclusion Criteria: Prior systemic therapy for advanced or metastatic disease (neoadjuvant therapy followed by surgical resection and adjuvant therapy permitted). Palliative radiotherapy to non-target lesions is allowed if completed at least two weeks prior to study entry Low grade tumors according to standard grading systems Prior therapy with ifosfamide or cyclophosphamide or other nitrogen mustards Prior therapy with an anthracycline or anthracenedione Prior mediastinal/cardiac radiotherapy Current use of drugs with known cardiotoxicity or known interactions with doxorubicin Anti-cancer treatment with radiation therapy, neoadjuvant or adjuvant chemotherapy, targeted therapies, immunotherapy, hormones or other antitumor therapies within 4 weeks prior to study entry (6 weeks for nitrosoureas or mitomycin C). Palliative radiotherapy to non-target lesions is allowed, is completed at least two weeks prior to study entry. Significant cardiac dysfunction precluding treatment with doxorubicin Seizure disorders requiring anticonvulsant therapy unless seizure-free for the last year Known brain metastases (unless previously treated and well controlled for a period of ≥ 3 months) Previously treated malignancies, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years Severe chronic obstructive or other pulmonary disease with hypoxemia or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia Major surgery, other than diagnostic surgery, within 4 weeks prior to Day 1, without complete recovery Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy Prior therapy with a hypoxic cytotoxin Subjects who participated in an investigational drug or device study within 28 days prior to study entry Known infection with HIV, hepatitis B, or hepatitis C Subjects who have exhibited allergic reactions to a structural compound similar to TH-302,doxorubicin or their excipients Females who are pregnant or breast-feeding Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study Unwillingness or inability to comply with the study protocol for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Tap, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
USC-Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6901
Country
United States
Facility Name
Sarcoma Oncology Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Facility Name
Stanford Comprehensive Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Cancer Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
South Florida Center for Gynecologic Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Mayo Clinic-Florida-Cancer Clinical Studies Unit
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
MD Anderson Cancer Center Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
H.Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute of Emory University, Midtown Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Kootenai Health - Kootenai Cancer Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Oncology Specialists
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Indiana University Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Health Care - University of Iowa Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10031
Country
United States
Facility Name
Columbia University Medical Center
City
NY
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolinas Hematology-oncology Associates-Blumenthal Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals Seidman Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pennsylvania Oncology Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburg Medical Center
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
MUSC - Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Virginia Commonwealth Universtiy-Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
University of Washington Cancer Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University Klinikum Graz
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Univ. Klinik fur Innere Medizin I Internistische Onkologie Medizinische Universitat Innsbruck
City
Innsbruck
ZIP/Postal Code
A-6020
Country
Austria
Facility Name
Allgemeines Krankenhaus Wien
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Universitaire Ziekenhuizen (UZ) Leuven - Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Juravinski Cancer Centre at Hamilton Health Sciences - Department of Medicine
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Tom Baker Cancer Centre
City
Calgary
ZIP/Postal Code
T2N4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
ZIP/Postal Code
T6G1Z2
Country
Canada
Facility Name
Ottawa Health Research Institue
City
Ottawa
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
BCCA- Vancouver Cancer Centre - Division of Medical Oncology
City
Vancouver
ZIP/Postal Code
V5Z4E6
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
ZIP/Postal Code
R3E0V9
Country
Canada
Facility Name
University Hospital Herlev at Copenhagen
City
Herlev
State/Province
Copenhagen
ZIP/Postal Code
2730
Country
Denmark
Facility Name
ICO Rene Gauducheau
City
Saint Herblain Cedex
State/Province
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Departement d'Oncologie Medicale
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Département d'Oncologie Moléculaire, Institut Paoli-Calmettes (IPC) and U119 Inserm
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse Cedex
ZIP/Postal Code
31052
Country
France
Facility Name
HELIOS Klinikum Berlin-Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Helios Klinikum Bad Saarow, Department of Hematology, Oncology, and Palliative Care, Sarcoma Center Berlin-Brandenburg
City
Berlin
ZIP/Postal Code
15526
Country
Germany
Facility Name
Universitätsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Krankenhaus Nordwest GmbH
City
Frankfurt
Country
Germany
Facility Name
Medizinische Hochschule Hannover (MHH) - Klinik fuer Haemonstaseologie, Onkologie und Stammzelltransplantation
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Div. of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center
City
Mannheim
ZIP/Postal Code
D-68165
Country
Germany
Facility Name
Wilhelm's University, Universitatsklinikum Muenster, Medizinische Klinik und Poliklinik A, Albert-Schweitzer-Campus 1
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Magyar Honvedseg Honvedkorhaz, Onkologiai Osztaly
City
Budapest
ZIP/Postal Code
H-1062
Country
Hungary
Facility Name
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Megyei Onkologiai Kozpont
City
Szolnok
ZIP/Postal Code
H-5004
Country
Hungary
Facility Name
Sharette Institute of Oncology, Hadassah-Hebrew University Medical Center, Hadassah Medical Org-Ein Karem
City
Kiryat Hadassah
State/Province
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
IRCCS Centro di Riferimento Oncologico-Struttura Operativa
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Facility Name
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
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Facility Name
Centro di Riferimento Oncologico (CRO)
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Azienda Ospedaliera Garibaldi
City
Catania
ZIP/Postal Code
95122
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria-Policlinico Paolo Giacco
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
ASL TO/2 di TORINO_Presidio Sanitario Gradenigo, S.C. di Oncologia
City
Torino
ZIP/Postal Code
10149
Country
Italy
Facility Name
Wojewodzkie Centrum Onkologii
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Centrum Onkologii Instytut im M. Sklodowskiej-Curie
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
GUZ "Regional Oncology Dispensay", Kazan
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
ROTSN RAMS them. Н.Н.Блохина NN Blokhin
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
FGU Moscow Research Institute of Oncology named after P.A. Hertzen of Rosmedtechnology
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
H.U. Canarias, Hospital Universitario de Canarias. Servicio de Oncología Médica
City
Tenerife
State/Province
Canarias
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Institut Catala d'Oncologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Sant Joan de Deu, Department de Oncologia
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal.
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Universidad Complutense Madrid Facultad de Medicina - Hospital Universitario 12 de Octubre, Servicio de Oncologia Medica Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28651927
Citation
Tap WD, Papai Z, Van Tine BA, Attia S, Ganjoo KN, Jones RL, Schuetze S, Reed D, Chawla SP, Riedel RF, Krarup-Hansen A, Toulmonde M, Ray-Coquard I, Hohenberger P, Grignani G, Cranmer LD, Okuno S, Agulnik M, Read W, Ryan CW, Alcindor T, Del Muro XFG, Budd GT, Tawbi H, Pearce T, Kroll S, Reinke DK, Schoffski P. Doxorubicin plus evofosfamide versus doxorubicin alone in locally advanced, unresectable or metastatic soft-tissue sarcoma (TH CR-406/SARC021): an international, multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2017 Aug;18(8):1089-1103. doi: 10.1016/S1470-2045(17)30381-9. Epub 2017 Jun 23. Erratum In: Lancet Oncol. 2018 Feb;19(2):e78.
Results Reference
derived
PubMed Identifier
25185097
Citation
Chawla SP, Cranmer LD, Van Tine BA, Reed DR, Okuno SH, Butrynski JE, Adkins DR, Hendifar AE, Kroll S, Ganjoo KN. Phase II study of the safety and antitumor activity of the hypoxia-activated prodrug TH-302 in combination with doxorubicin in patients with advanced soft tissue sarcoma. J Clin Oncol. 2014 Oct 10;32(29):3299-306. doi: 10.1200/JCO.2013.54.3660. Epub 2014 Sep 2.
Results Reference
derived

Learn more about this trial

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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