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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01168791




Registration number
NCT01168791
Ethics application status
Date submitted
21/07/2010
Date registered
23/07/2010
Date last updated
18/07/2013

Titles & IDs
Public title
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
Scientific 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.
Secondary ID [1] 0 0
IPM3001
Universal Trial Number (UTN)
Trial acronym
PICASSO III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Soft Tissue Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - doxorubicin in combination with palifosfamide-tris
Treatment: Drugs - doxorubicin in combination with placebo

Experimental: doxorubicin plus palifosfamide-tris -

Active comparator: doxorubicin plus placebo -


Treatment: Drugs: doxorubicin in combination with palifosfamide-tris
palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles.

doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles.

Treatment: Drugs: doxorubicin in combination with placebo
doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles.

placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival followed by Overall Survival
Timepoint [1] 0 0
assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death
Secondary outcome [1] 0 0
Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires
Timepoint [1] 0 0
assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death
Secondary outcome [2] 0 0
Safety and Tolerability as evaluated using CTCAE v 4.0
Timepoint [2] 0 0
22 weeks

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
447
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
North Adelaide Oncology - Adelaide
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [3] 0 0
- Camperdown
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- East Melbourne
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The Canberra Hospital - Garran
Recruitment hospital [6] 0 0
- Garran
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- Kurralta Park
Recruitment hospital [8] 0 0
- Nedlands
Recruitment hospital [9] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
SA 5006 - Adelaide
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- Adelaide
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- Camperdown
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- East Melbourne
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- Garran
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- Kurralta Park
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- Nedlands
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NSW 2031 - Randwick
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4102 - Woolloongabba
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alaunos Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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).
Trial website
https://clinicaltrials.gov/study/NCT01168791
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01168791