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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT01440088

Public ClinicalTrials.gov record NCT01440088. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 4:04 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01440088
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Threshold Pharmaceuticals
Industry
Enrollment
640 participants

Conditions and interventions

Eligibility (public fields only)

Age range
15 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 31, 2011
Primary completion
Nov 30, 2015
Completion
Apr 30, 2016
Last update posted
Jun 1, 2016

2011 – 2016

United States locations

U.S. sites
44
U.S. states
25
U.S. cities
38
Facility City State ZIP Site status
Mayo Arizona Scottsdale Arizona 85259
Arizona Cancer Center Tucson Arizona 85719
USC-Norris Comprehensive Cancer Center Los Angeles California 90033
University of California, Los Angeles Los Angeles California 90095-6901
Sarcoma Oncology Center Santa Monica California 90403
Stanford Comprehensive Cancer Center Stanford California 94305
Georgetown University Hospital Washington D.C. District of Columbia 20007
Washington Cancer Institute Washington D.C. District of Columbia 20010
South Florida Center for Gynecologic Oncology Boca Raton Florida 33487
Mayo Clinic-Florida-Cancer Clinical Studies Unit Jacksonville Florida 32224
MD Anderson Cancer Center Orlando Orlando Florida 32806
H.Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612
Winship Cancer Institute of Emory University, Midtown Campus Atlanta Georgia 30322
Kootenai Health - Kootenai Cancer Center Coeur d'Alene Idaho 83814
Northwestern University Chicago Illinois 60611
Rush University Medical Center Chicago Illinois 60612
Oncology Specialists Park Ridge Illinois 60068
Indiana University Simon Cancer Center Indianapolis Indiana 46202
University of Iowa Health Care - University of Iowa Hospital Iowa City Iowa 52242
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Hospital Baltimore Maryland 21287
Dana Farber Cancer Institute Center for Sarcoma and Bone Oncology Boston Massachusetts 02215
University of Michigan Cancer Center Ann Arbor Michigan 48109
Mayo Rochester Rochester Minnesota 55905
Washington University School of Medicine St Louis Missouri 63110
Roswell Park Cancer Institute Buffalo New York 14263
Memorial Sloan-Kettering Cancer Center New York New York 10031
Columbia University Medical Center New York New York 10032
Montefiore The Bronx New York 10461
Carolinas Hematology-oncology Associates-Blumenthal Cancer Center Charlotte North Carolina 28203
Duke University Medical Center Durham North Carolina 27710
Wake Forest University Baptist Medical Center Winston-Salem North Carolina 27157
University Hospitals Seidman Cancer Center Cleveland Ohio 44106
Cleveland Clinic Foundation Cleveland Ohio 44195
The Arthur G. James Cancer Hospital and Richard J Solove Research Institue, The Ohio State University Comprehensive Cancer Center Columbus Ohio 43202
Oregon Health and Science University Portland Oregon 97239
Pennsylvania Oncology Hematology Associates Philadelphia Pennsylvania 19106
Fox Chase Cancer Center Philadelphia Pennsylvania 19111
University of Pittsburg Medical Center Pittsburgh Pennsylvania 15232
MUSC - Hollings Cancer Center Charleston South Carolina 29425
Vanderbilt-Ingram Cancer Center Nashville Tennessee 37232
University of Vermont Burlington Vermont 05405
Virginia Commonwealth Universtiy-Massey Cancer Center Richmond Virginia 23298
University of Washington Cancer Center Seattle Washington 98109
Medical College of Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 48 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01440088, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 1, 2016 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01440088 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →