Hana Biosciences Begins Phase I/II Trial of PT-523 in NSCLC

Hana Biosciences has initated a Phase I/II clinical trial of PT-523 as a single agent in relapsed non-small cell lung cancer (NSCLC).

The Phase I component of the new study is a multicenter, multinational trial which will first determine the dose, safety, tolerability, pharmacokinetics and preliminary efficacy of PT-523 in NSCLC patients (second- and third-line patients).

The Phase II component will utilize the maximum-tolerated dose (MTD) 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 and tolerability.

The trial is expected to enroll between 80 and 120 patients over the next 12 to 15 months. Several leading clinical research sites in the U.S. and Eastern Europe are expected to participate in the trial.