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.
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
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
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
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
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
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
Argentina5 sites
Study site
Ciudad de Buenos Aires
Study site
Córdoba
Study site
Ramos Mejía
Instituto CAICI
Rosario
Study site
Sante Fe
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
Germany5 sites
HELIOS Klinikum Berlin Buch
Bad Sarrow
Universitätsklinikum Köln
Cologne
Study site
Hanover
Study site
Mannheim
Tuebingen University Hospital
Tübingen
India5 sites
Study site
Jaipur
Study site
Mumbai
Study site
Nashik
Study site
Pune
Study site
Secunderabad
Belgium4 sites
Study site
Antwerp
Study site
Brussels
Study site
Leuven
Study site
Liège
Russia4 sites
Study site
Moscow
Study site
Obninsk
Study site
Saint Petersburg
Study site
Yaroslavl
Spain4 sites
Study site
Badalona
Study site
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Study site
Valencia
Chile3 sites
Study site
Santiago
Instituto Clínico Oncológico del Sur
Temuco
Study site
Viña del Mar
Italy3 sites
Study site
Candiolo
Humanitas Cancer Center
Rozzana
Ospedale Gradenigo Oncology
Torino
Poland3 sites
Wojewodzkie Centrum Onkologii
Gdansk
Study site
Gilwice
Centrum Onkologii Instytut
Warsaw
Panama2 sites
Centro Hemato Oncologico Paitilla
Panama City
Medical and Research Center
Panama City
United Kingdom2 sites
The Royal Marsden NHS Foundation Trust Sarcoma
London, SW3 6JJ
Christie Hospital NHS Foundation Trust
Manchester
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).
- Conditions
- Soft Tissue Sarcoma
- 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 group | Role | What they receive |
|---|---|---|
| doxorubicin plus palifosfamide-tris | Experimental | Participants 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 placebo | Active comparator | Participants 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.
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)
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
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.
- First posted23 Jul 2010 (estimated)
- Study start16 Aug 2010
- Primary completion13 Mar 2013
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Alaunos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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