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Terminated Phase 3 Interventional

Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma

ClinicalTrials.gov ID: NCT01168791

Public ClinicalTrials.gov record NCT01168791. 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 23, 2026, 11:34 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 Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.

Brief summary

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

This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

Study identification

NCT ID
NCT01168791
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Alaunos Therapeutics
Industry
Enrollment
447 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 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 16, 2010 (Actual)
Primary completion
Mar 13, 2013 (Actual)
Completion
Mar 13, 2013 (Actual)
Last update posted
Oct 6, 2026

2010 – 2013

United States locations

U.S. sites
73
U.S. states
38
U.S. cities
68
Facility City State ZIP Site status
Not listed Birmingham Alabama — —
Arizona Oncology Associates Phoenix Arizona — —
Not listed Scottsdale Arizona — —
Arizona Cancer Center Tucson Arizona 85724 —
University of Arkansas for Medical Sciences Little Rock Arkansas 72205 —
University of California, Los Angeles Los Angeles California — —
Not listed Los Angeles California — —
University of California, Irvine Orange California — —
Not listed Pomona California — —
Sarcoma Oncology Center Santa Monica California — —
University of Colorado Cancer Center Aurora Colorado — —
Rocky Mountain Cancer Centers Denver Colorado — —
Medical Oncology Hematology Consultants Newark Delaware — —
MedStar Research Institute Washington D.C. District of Columbia — —
Not listed Washington D.C. District of Columbia — —
Not listed Jacksonville Florida — —
Not listed Orlando Florida — —
Moffitt Cancer Center Tampa Florida — —
Palm Beach Cancer Institute West Palm Beach Florida — —
Emory Atlanta Georgia — —
Medical College of Georgia Augusta Georgia — —
Kootenai Cancer Center Post Falls Idaho 83854 —
Not listed Chicago Illinois — —
Not listed Park Ridge Illinois — —
Indiana University Simon Cancer Center Indianapolis Indiana — —
University of Iowa Hospital and Clinics Iowa City Iowa — —
Kansas City Cancer Center Overland Park Kansas — —
Not listed New Orleans Louisiana — —
LSU Health Sciences Center, Feist-Weiller Cancer Center Shreveport Louisiana — —
Not listed Baltimore Maryland — —
Dana-Farber Cancer Institute Boston Massachusetts — —
Not listed Ann Arbor Michigan — —
Mayo Clinic Rochester Minnesota — —
St.Louis University St Louis Missouri 63110 —
Washington University School of Medicine St Louis Missouri — —
Not listed Las Vegas Nevada — —
Not listed Hackensack New Jersey — —
Not listed Morristown New Jersey — —
Saint Barnabas West Orange New Jersey — —
Not listed Albuquerque New Mexico — —
Mount Sinai School of Medicine New York New York 10029 —
Columbia University Medical Center New York New York — —
University of Rochester Rochester New York — —
Not listed The Bronx New York — —
University of North Carolina Chapel Hill North Carolina — —
Not listed Durham North Carolina — —
Not listed Raleigh North Carolina — —
Wake Forest University Health Sciences Winston-Salem North Carolina — —
Summa Health System Akron Ohio — —
UC Cancer Institute Cincinnati Ohio — —
Cleveland Clinic Cleveland Ohio — —
The Ohio State University Medical Center Columbus Ohio — —
Cancer Care Associates Tulsa Oklahoma — —
Oregon Health and Science University Portland Oregon — —
Not listed Bethlehem Pennsylvania — —
Fox Chase Cancer Center Philadelphia Pennsylvania — —
Pennsylvania Oncology/Hematology Associates Philadelphia Pennsylvania — —
University of Pittsburgh Pittsburgh Pennsylvania 15232 —
Not listed Providence Rhode Island — —
Not listed Charleston South Carolina — —
Cancer Centers of the Carolinas Greenville South Carolina — —
Not listed Memphis Tennessee — —
Not listed Nashville Tennessee — —
Texas Oncology Bedford Texas — —
Texas Oncology - Medical City Dallas Dallas Texas — —
Cancer Therapy and Research Center San Antonio Texas 8229 —
Utah Cancer Specialists Salt Lake City Utah — —
Not listed Burlington Vermont — —
Virginia Cancer Specialists Fairfax Virginia — —
University of Washington/Seattle Cancer Care Alliance Seattle Washington — —
Bellin Cancer Center Green Bay Wisconsin 54313 —
University of Wisconsin Madison Wisconsin — —
Not listed Milwaukee Wisconsin — —

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 88 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01168791, 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 Oct 6, 2026 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01168791 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →