Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Ziopharm Oncology has initiated the international, randomised, double-blinded, placebo-controlled pivotal Phase III clinical trial called Picasso 3 for Palifosfamide (Zymafos) in patients with front-line metastatic soft tissue sarcoma who have never been treated with chemotherapy for metastatic disease.
Subscribe to our email newsletter
Picasso 3 is designed to assess the safety and efficacy of Palifosfamide administered with doxorubicin compared with doxorubicin administered with placebo, with no crossover between arms.
Picasso 3 primary endpoint is the progression-free survival (PFS) for accelerated approval, with overall survival (OS) as the primary endpoint for full approval. Palifosfamide has orphan drug status in both Europe and the US.
Ziopharm Oncology said that the pivotal trial protocol was developed in a process with the FDA that included discussion at an end of Phase II meeting and a subsequent dialogue for Special Protocol Assessment (SPA). FDA advised that PFS could be used as a primary endpoint outside of formal SPA with the study outcome subject to review. Regulatory acceptability is expected to depend on the magnitude of the difference between the trial study arms as well as a risk and benefit analysis.
Ziopharm Oncology’s Picasso 3 study is designed as a close follow-on study to the publicly-reported Picasso trial, which demonstrated a improvement in PFS for the combination over doxorubicin alone.
Picasso 3 is expected to be conducted at about 150 centers in North America, Europe, South America, Australia, Israel and Korea.
George Demetri, a member of the scientific advisory board at Ziopharm, said: “Picasso 3 is powered to show a improvement in disease control, as assessed by PFS. This design allows for the possibility of accelerated approval using a PFS endpoint.”