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PICASSO 3: Phase III Randomized Controlled Trial in Soft Tissue Sarcoma

ZIOPHARM Oncology, Inc. has initiated enrollment in its global Phase III randomized controlled trial of palifosfamide in combination with doxorubicin in subjects with front-line metastatic soft-tissue sarcoma. Progression-free survival (PFS) is the primary endpoint for accelerated approval, with overall survival (OS) as the primary endpoint for full approval. The secondary objectives are to assess the quality of life and safety and tolerability of the combination.

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 in the randomized Phase II setting, which suggests it may offer patients a better option than the current standard of care which is doxorubicin alone.

Study Design

• International, multi-center randomized, double-blind, placebo-controlled trial
• Randomization into 1 of 2 arms either to receive palifosfamide-tris plus doxorubicin or to receive doxorubicin plus placebo.

 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 tumor/carcinosarcoma, osteosarcoma, radiation induced sarcomas, and low grade (grade 1) sarcomas. (Myxoid liposarcoma with t(12;16) or t(12;22) is permitted).
• Age > 18 years.
• ECOG performance status 0 or 1.

Additional Information

• Additional information can be obtained from Jill Buck at 617-259-1970.

This trial is sponsored by ZIOPHARM Oncology, Inc.