AzTrials
AzTrials

Soft Tissue SarcomaPhase 3PICASSO IIINCT01168791

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

A Phase 3 study testing Palifosfamide-Tris and doxorubicin in people with Soft Tissue Sarcoma, run by Alaunos Therapeutics at 161 sites in 21 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Palifosfamide-Tris and doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
447 participants
Where
161 sitesin 21 countries
Study dates
16 Aug 2010to 13 Mar 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

To be eligible, each patient must meet EACH of the following criteria:

  • Age ≥18 years.
  • Documented soft tissue sarcoma
  • Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable.
  • ECOG Performance Status of 0, 1 or 2
  • Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
  • Male and female patients must agree to use a highly reliable method of birth control during study participation.
  • Able to provide informed consent

To be eligible, each patient must meet NONE of the following criteria:

  • Specific sarcoma histological subtypes including GIST and Ewing's sarcoma.
  • Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease
  • Any prior anthracycline use.
  • Known allergy to any of the study drugs or their excipients.
  • Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
  • Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) <50%.
  • Documented metastases to brain or meninges.
  • Any malignancy other than sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
  • Currently pregnant or nursing.
  • Radiotherapy with curative intent within 4 weeks of first dose of study drug.

Trial locations and contacts

161 sites in 21 countries.

161 sites in 21 countries

United States73 sites

  • Summa Health System

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Ann Arbor, Michigan

  • Emory

    Atlanta, Georgia

  • Medical College of Georgia

    Augusta, Georgia

  • University of Colorado Cancer Center

    Aurora, Colorado

  • Study site

    Baltimore, Maryland

  • Texas Oncology

    Bedford, Texas

  • Study site

    Bethlehem, Pennsylvania

  • Study site

    Birmingham, Alabama

  • Dana-Farber Cancer Institute

    Boston, Massachusetts

  • Study site

    Burlington, Vermont

  • University of North Carolina

    Chapel Hill, North Carolina

  • Study site

    Charleston, South Carolina

  • Study site

    Chicago, Illinois

  • UC Cancer Institute

    Cincinnati, Ohio

  • Cleveland Clinic

    Cleveland, Ohio

  • The Ohio State University Medical Center

    Columbus, Ohio

  • Texas Oncology - Medical City Dallas

    Dallas, Texas

  • Rocky Mountain Cancer Centers

    Denver, Colorado

  • Study site

    Durham, North Carolina

  • Virginia Cancer Specialists

    Fairfax, Virginia

  • Bellin Cancer Center

    Green Bay, Wisconsin, 54313

  • Cancer Centers of the Carolinas

    Greenville, South Carolina

  • Study site

    Hackensack, New Jersey

  • Indiana University Simon Cancer Center

    Indianapolis, Indiana

  • University of Iowa Hospital and Clinics

    Iowa City, Iowa

  • Study site

    Jacksonville, Florida

  • Study site

    Las Vegas, Nevada

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • University of California, Los Angeles

    Los Angeles, California

  • Study site

    Los Angeles, California

  • University of Wisconsin

    Madison, Wisconsin

  • Study site

    Memphis, Tennessee

  • Study site

    Milwaukee, Wisconsin

  • Study site

    Morristown, New Jersey

  • Study site

    Nashville, Tennessee

  • Study site

    New Orleans, Louisiana

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York

  • Medical Oncology Hematology Consultants

    Newark, Delaware

  • University of California, Irvine

    Orange, California

  • Study site

    Orlando, Florida

  • Kansas City Cancer Center

    Overland Park, Kansas

  • Study site

    Park Ridge, Illinois

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania

  • Pennsylvania Oncology/Hematology Associates

    Philadelphia, Pennsylvania

  • Arizona Oncology Associates

    Phoenix, Arizona

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232

  • Study site

    Pomona, California

  • Oregon Health and Science University

    Portland, Oregon

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Study site

    Providence, Rhode Island

  • Study site

    Raleigh, North Carolina

  • Mayo Clinic

    Rochester, Minnesota

  • University of Rochester

    Rochester, New York

  • Utah Cancer Specialists

    Salt Lake City, Utah

  • Cancer Therapy and Research Center

    San Antonio, Texas, 8229

  • Sarcoma Oncology Center

    Santa Monica, California

  • Study site

    Scottsdale, Arizona

  • University of Washington/Seattle Cancer Care Alliance

    Seattle, Washington

  • LSU Health Sciences Center, Feist-Weiller Cancer Center

    Shreveport, Louisiana

  • St.Louis University

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri

  • Moffitt Cancer Center

    Tampa, Florida

  • Study site

    The Bronx, New York

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Cancer Care Associates

    Tulsa, Oklahoma

  • MedStar Research Institute

    Washington D.C., District of Columbia

  • Study site

    Washington D.C., District of Columbia

  • Saint Barnabas

    West Orange, New Jersey

  • Palm Beach Cancer Institute

    West Palm Beach, Florida

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina

Other trials in United States

Australia10 sites

  • North Adelaide Oncology

    Adelaide, SA 5006

  • Royal Adelaide Hospital

    Adelaide

  • Study site

    Camperdown

  • Study site

    East Melbourne

  • The Canberra Hospital

    Garran

  • Study site

    Garran

  • Study site

    Kurralta Park

  • Study site

    Nedlands

  • Prince of Wales Hospital

    Randwick, NSW 2031

  • Princess Alexandra Hospital

    Woolloongabba, 4102

Other trials in Australia

Brazil10 sites

  • Institution name: Hospital de Câncer de Barretos - Fundação PIOXII

    Barretos

  • Study site

    Belo Horizonte

  • Santa Casa da Misericórdia de Curitiba

    Curitiba

  • Study site

    Florianópolis

  • Study site

    Jaú

  • Hospital da Cidade de Passo Fundo

    Passo Fundo

  • Hospital das Clínicas de Porto Alegre

    Porto Alegre

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre

  • Centro de Oncologia da Bahia

    Salvador

  • Study site

    São Paulo

Other trials in Brazil

France9 sites

  • Study site

    Angers

  • Study site

    Bordeaux

  • Institut Paoli Calmettes

    Marseille

  • Study site

    Marseille

  • Study site

    Montpellier

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Toulouse

  • Study site

    Villejuif

Other trials in France

Israel6 sites

  • Study site

    Haifa

  • Shaare Zedek Medical Center

    Jerusalem

  • Study site

    Jerusalem

  • Study site

    Petah Tikva

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Argentina5 sites

  • Study site

    Ciudad de Buenos Aires

  • Study site

    Córdoba

  • Study site

    Ramos Mejía

  • Instituto CAICI

    Rosario

  • Study site

    Sante Fe

Other trials in Argentina

Canada5 sites

  • Study site

    Calgary, Alberta

  • Cross Cancer Institute

    Edmonton, Alberta

  • Jewish General Hospital

    Montreal, Quebec

  • McGill University

    Montreal, Quebec

  • Mount Sinai Hospital

    Toronto, Ontario

Other trials in Canada

Germany5 sites

  • HELIOS Klinikum Berlin Buch

    Bad Sarrow

  • Universitätsklinikum Köln

    Cologne

  • Study site

    Hanover

  • Study site

    Mannheim

  • Tuebingen University Hospital

    Tübingen

Other trials in Germany

India5 sites

  • Study site

    Jaipur

  • Study site

    Mumbai

  • Study site

    Nashik

  • Study site

    Pune

  • Study site

    Secunderabad

Other trials in India

Belgium4 sites

  • Study site

    Antwerp

  • Study site

    Brussels

  • Study site

    Leuven

  • Study site

    Liège

Other trials in Belgium

Russia4 sites

  • Study site

    Moscow

  • Study site

    Obninsk

  • Study site

    Saint Petersburg

  • Study site

    Yaroslavl

Other trials in Russia

Spain4 sites

  • Study site

    Badalona

  • Study site

    Madrid

  • Hospital Universitario Puerta de Hierro

    Majadahonda

  • Study site

    Valencia

Other trials in Spain

Chile3 sites

  • Study site

    Santiago

  • Instituto Clínico Oncológico del Sur

    Temuco

  • Study site

    Viña del Mar

Other trials in Chile

Colombia3 sites

  • Study site

    Bogotá

  • Study site

    Medellín

  • Study site

    Montería

Other trials in Colombia

Italy3 sites

  • Study site

    Candiolo

  • Humanitas Cancer Center

    Rozzana

  • Ospedale Gradenigo Oncology

    Torino

Other trials in Italy

Poland3 sites

  • Wojewodzkie Centrum Onkologii

    Gdansk

  • Study site

    Gilwice

  • Centrum Onkologii Instytut

    Warsaw

Other trials in Poland

Romania3 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

Other trials in Romania

Panama2 sites

  • Centro Hemato Oncologico Paitilla

    Panama City

  • Medical and Research Center

    Panama City

Other trials in Panama

United Kingdom2 sites

  • The Royal Marsden NHS Foundation Trust Sarcoma

    London, SW3 6JJ

  • Christie Hospital NHS Foundation Trust

    Manchester

Other trials in United Kingdom

Guatemala1 site

  • Study site

    Guatemala City

Other trials in Guatemala

Singapore1 site

  • Study site

    Singapore

Other trials in Singapore

About this study

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.

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).

Being tested
Palifosfamide-Tris, doxorubicin, Placebo
Keywords
Metastatic, Front line
Medical subject headings
Sarcoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Palifosfamide-TrisDrug

    Also called ZIO-201, isophosphoramide mustard

    Palifosfamide-tris 150 mg/m² administered intravenously on Days 1, 2, and 3 of each 21-day cycle for a maximum of 6 cycles.

  • doxorubicinDrug

    Also called Adriamycin

    Doxorubicin 75 mg/m² administered intravenously on Day 1 of each 21-day cycle for a maximum of 6 cycles.

  • PlaceboDrug

    250 mL normal saline administered intravenously on Days 1, 2, and 3 of each 21-day cycle for a maximum of 6 cycles.

Study groups in NCT01168791
Study groupRoleWhat they receive
doxorubicin plus palifosfamide-trisExperimentalParticipants received doxorubicin 75 mg/m² IV on Day 1 plus palifosfamide-tris 150 mg/m² IV on Days 1, 2, and 3 of each 21-day cycle for a maximum of 6 cycles.
Receives: Drug: Palifosfamide-Tris; Drug: doxorubicin
doxorubicin plus placeboActive comparatorParticipants received doxorubicin 75 mg/m² IV on Day 1 plus placebo IV on Days 1, 2, and 3 of each 21-day cycle for a maximum of 6 cycles.
Receives: Drug: doxorubicin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival followed by Overall Survival

    Measured: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death

Secondary outcomes (2)

  1. Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires

    Measured: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death

  2. Safety and Tolerability as evaluated using CTCAE v 4.0

    Measured: 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2010 (estimated)
  2. Study start16 Aug 2010
  3. Primary completion13 Mar 2013
  4. Study completion13 Mar 2013

Why it stopped: Primary endpoint (PFS) not met at the final analysis; sponsor decided to stop the study before the planned final overall survival analysis.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01168791
Sponsor's protocol ID
IPM3001
Acronym
PICASSO III
Status last verified
Oct 2026
First submitted
21 Jul 2010
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Ryan CW, Merimsky O, Agulnik M, Blay JY, Schuetze SM, Van Tine BA, Jones RL, Elias AD, Choy E, Alcindor T, Keedy VL, Reed DR, Taub RN, Italiano A, Garcia Del Muro X, Judson IR, Buck JY, Lebel F, Lewis JJ, Maki RG, Schoffski P. PICASSO III: A Phase III, Placebo-Controlled Study of Doxorubicin With or Without Palifosfamide in Patients With Metastatic Soft Tissue Sarcoma. J Clin Oncol. 2016 Nov 10;34(32):3898-3905. doi: 10.1200/JCO.2016.67.6684. Epub 2016 Sep 30.

    PubMed 27621408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palifosfamide-Tris and doxorubicin in people with Soft Tissue Sarcoma, run by Alaunos Therapeutics at 161 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in United States, Australia, Brazil, France, Israel and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Primary endpoint (PFS) not met at the final analysis; sponsor decided to stop the study before the planned final overall survival analysis.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival followed by Overall Survival (time frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01168791, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in