The Central European Society for Anticancer Drug Research (CESAR) in collaboration with Saladax Biomedical has begun enrollment in the CEPAC-TDM trial of paclitaxel therapeutic drug management (TDM) with subsequent pharmacokinetic-guided dose adjustment in patients being treated for advanced non-small cell lung cancer.
The study will determine if optimizing dosing of paclitaxel will reduce grade 4 neutropenia, without affecting progression-free survival and overall survival. Saladax is developing a nanoparticle-based automated immunoassay to provide rapid, simple and cost-effective measurement of paclitaxel levels to allow timely personalized dose adjustment.
This multicenter, randomized trial will enroll 280 patients. In the first phase of the study, eight study centers will participate in Germany and Switzerland.