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 completed enrollment in PICASSO 3 trial of palifosfamide in combination with doxorubicin, versus doxorubicin alone, for the treatment of metastatic soft tissue sarcoma (STS) in the front-line setting.
Subscribe to our email newsletter
The randomized, double-blind, placebo-controlled Phase 3 study is designed to evaluate the safety and efficacy of palifosfamide and doxorubicin compared to doxorubicin and placebo, with no crossover between study arms.
Doxorubicin is the current standard of care for the treatment of STS in the front-line setting.
Ziopharm chief executive officer Jonathan Lewis said that throughout the enrollment process for PICASSO 3 the company has maintained rigorous criteria to ensure that it closely mirrors the successful, randomized Phase 2 PICASSO study.
"As we look forward to top-line data in the second half of this year, we will continue to expand our palifosfamide program with the initiation of enrollment in the Phase 3 MATISSE study in small cell lung cancer," Lewis added.
The primary endpoint for accelerated approval is the progression-free survival where as the primary endpoint for full approval is the overall survival.
The company expects data for the study’s primary endpoint for accelerated approval in the second half of 2012.