Carcinoma, Squamous Cell of Head and Neck Clinical Trial
Official title:
Phase I/II Clinical Trial of NC-6004 in Combination With 5-FU and Cetuximab as First-line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Part 1 of this study will establish a recommended Phase II (RPII) dose for the triplet combination of NC-6004 plus 5-Fluorouracil (5-FU) and cetuximab. Part 2 will provide the efficacy signal of the triplet combination in this patient population.
NC-6004 is a polymeric micelle-containing cisplatin as an active moiety. The nanoparticle provides sustained release of the active moiety and utilizes the enhanced permeability and retention effect to target release of platinum to tumors. Currently available nonclinical data and enhanced pharmacokinetics suggest that NC-6004 has the potential to be more active than cisplatin, with increased tolerability. ;
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