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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 Oct 19, 2026, 11:34 PM 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
Sep 2011 (Type not available)
Primary completion
Dec 2015 (Actual)
Completion
May 2016 (Actual)
Last update posted
Jun 2, 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 2, 2016 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01440088 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →