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PICASSO: Phase II Randomized Controlled Trial Soft-Tissue Sarcoma

ZIOPHARM Oncology, Inc. has concluded enrollment of its global Phase II randomized controlled trial of palifosfamide in subjects with unresectable or metastatic soft-tissue sarcoma. A Phase II multicenter, parallel group, randomized study of palIfosfamide tris plus doxorubicin versus doxorubiCin in subjects with unresectAble or metastatic Soft tissue SarcOma (PICASSO). The primary objective of the study is to assess the difference in progression-free survival (PFS) between subjects treated with palifosfamide plus doxorubicin versus doxorubicin alone. A secondary objective is to assess the safety, tolerability and the response of the subjects to both regimens treated in the study.

Sarcoma is a rare cancer that arises from a variety of tissue structures in the body, including nerves, joints, bone and blood vessels. Sarcoma can be treated with surgery or surgery plus chemotherapy. However, there are cases where physicians and subjects will need additional options to help manage the disease.  Palifosfamide has demonstrated activity in treating patients with soft tissue sarcoma (STS) alone and in combination with doxorubicin, which suggests it may offer patients a better option than the current standard of care which is doxorubicin alone.

Study Design

• Multi-center randomized controlled trial with numerous U.S. and international sites.
• Randomization into 1 of 2 arms either to receive palifosfamide plus doxorubicin or to receive doxorubicin alone.
• After 6 cycles of doxorubicin, subjects will be discontinued from doxorubicin in both arms as the cumulative dose will be considered the maximum upper limit.
• Subjects randomized to the palifosfamide/doxorubicin arm may continue treatment with palifosfamide beyond 6 cycles until subjects are taken off the drug do to side effects or disease progression.
• Subjects in the single-agent doxorubicin arm who progress at or before cycle 6 will be given the option of receiving single agent palifosfamide.

 Eligibility Criteria

• Eligible subjects have been diagnosed with advanced, histologically confirmed STS excluding alveolar soft-part sarcoma, chondrosarcoma, dermatofibrosarcoma, Ewing sarcoma, GIST, Kaposi sarcoma mixed mesodermal sarcoma, osteosarcoma, radiation induced sarcoma and unresectable low-grade liposarcoma.
• Prior therapy with ifosfamide is acceptable.
• Age > 18 years.
• ECOG performance status 0 or 1.

Additional Information

• Trial information is also at www.ClinicalTrials.gov.
• Additional information can be obtained from Jan Stevens at 617-259-1970.

This trial is sponsored by ZIOPHARM Oncology, Inc.