The PICASSO III Study Version 1
Research type
Research Study
Full 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
IRAS ID
55545
Contact name
Ian Robert Judson
Sponsor organisation
ZIOPHARM Oncology Inc
Eudract number
2010-019866-96
Clinicaltrials.gov Identifier
Research summary
Soft tissue sarcomas are a diverse group of rare tumours which account for less than 1% of all solid tumours in adults. They can develop at any site in the body. There are approximately 3000 new cases a year in the UK. Despite their differences, once they are metastatic they are treated similarly (with some exceptions). Initial treatment consists of surgical resection with possible adjuvant radiation however; many patients present with or develop metastatic disease which is treated with chemotherapy which is regarded as palliative. However, in a small subset of patients long term survival is achieved. Although there have been improvements in the molecular and biological understanding, it has been very difficult to improve the outcome in this disease. The aim is to see if palifosfamide-tris with doxorubicin can extend the duration of stable disease and increase the overall survival in comparison to doxorubicin alone. Safety data will be collected to establish if there are differences in side effects between the two treatments. It is a randomized, double-blind, placebo controlled phase 3 study with a 1:1 randomization. 424 patients will be enrolled at approximately 100 global sites. In Arm A patients will receive 150mg/ m² of palifosfamide-tris and 75mg/ m² on Day 1 of each 21 day cycle and have palifosfamide-tris alone on days 2 and 3. In Arm B patients will receive the same doxorubicin on day 1 and placebo on days 1, 2 and 3. There is a maximum of 6 treatment cycles for each arm. Throughout the study, patients will visit the site for their treatments and study assessments including tumour assessment, 12 lead ECG, LVEF, physical exams, vital signs, weight, ECOG performance status assessment, blood and urine testing, pregnancy testing (if applicable), and patient questionnaires .The sponsor is ZIOPHARM Oncology, Inc., One First Avenue, Parris Building 34, Boston, MA 02129 USA.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
10/H0707/71
Date of REC Opinion
26 Nov 2010
REC opinion
Further Information Favourable Opinion