The phase I component of the new study is a multi-center, multi-national trial which will first determine the dose, safety, tolerability, pharmacokinetics and preliminary efficacy of PT-523 in non-small cell lung cancer (NSCLC) patients.
The phase II component will utilize the maximally tolerated dose in the same schedule, with the primary efficacy endpoint being overall survival. Secondary endpoints will include time-to-progression, progression-free survival, response rate, and safety/tolerability.
PT-523 is currently completing a phase I trial in patients with advanced solid tumors. The new study will focus specifically on relapsed non-small cell lung cancer patients using a more common dosing schedule for lung cancer treatment.
“The initiation of this study marks another important milestone in the development of PT-523,” commented Dr Greg Berk, chief medical officer and vice-president of Hana Biosciences. “The level of interest in this compound in the academic oncology community has been very encouraging, and we are particularly pleased that several leading lung cancer experts are involved with this clinical trial.”
Hana Biosciences is also planning trials with PT-523 in gynecologic cancers and lymphoid leukemias.