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Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer

Head and Neck Neoplasms Clinical Trial

Official title:
Phase I Study of NC-6004 in Combination With 5-FU and Cetuximab as First-line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck

Clinical Trial Summary

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 (EPR) effect to target release of platinum to tumors. This Phase I study aims to establish a recommended dose (RD) for the triplet combination of NC-6004 plus 5-FU and cetuximab as first-line treatment in patient with recurrent and/or metastatic squamous cell carcinoma of the head and neck for further clinical study development.

Clinical Trial Description

1. Primary objectives ♦ To determine the Maximum Tolerated Dose (MTD) of NC-6004 according to the Dose Limiting Toxicity (DLT) in combination with 5-FU plus cetuximab as firstline treatment in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN), and to decide the RD for the following studies 2. Secondary objectives 1). To evaluate the safety and tolerability profile of NC-6004 in combination with 5- FU plus cetuximab 2). To assess the pharmacokinetic effects of NC-6004 3). To assess the antitumor effects of NC-6004 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02817113
Study type Interventional
Source Orient Europharma Co., Ltd.
Contact
Status Terminated
Phase Phase 1
Start date June 2016
Completion date September 2018
View Details
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