The Belief registration trial is a multicenter, open-label, single arm efficacy and safety study in patients with relapsed or refractory PTCL, who have failed at least one prior systemic therapy.
The primary endpoint is centrally reviewed objective overall response rate (ORR).
Spectrum Pharma chairman and CEO Rajesh Shrotriya said Belinostat is a novel HDAC inhibitor that has the potential to play an important role in therapy for PTCL, and in a variety of other indications.
"We plan to file a new drug application in 2012," Shrotriya said.