The trial is being initiated following FDA and central institutional review board (IRB) approval of the trial protocol. The study builds on the observation of prolonged stable disease experienced by heavily-pretreated non-small cell lung cancer (NSCLC) patients enrolled in a phase I study of single agent seliciclib.
Approximately 160 patients from 20 centers in the US will participate in the study. The trial’s primary efficacy endpoint is progression free survival, while secondary endpoints include overall survival, response rate, response duration, safety and tolerability.
Patients who achieve stable disease after three cycles will be randomized to continue on seliciclib or receive placebo with best supportive care. Patients in the placebo group whose disease progresses will be given the option to cross-over and receive seliciclib treatment again.
“We have been interested in evaluating seliciclib, our lead cell cycle inhibitor, as a treatment for lung cancer for some time. The APPRAISE study is a key next step in our program to assess the antitumor activity of seliciclib as a monotherapy for lung cancer,” said Spiro Rombotis, president and CEO of Cyclacel.