drugset / Trial / NCT02817113

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

NCT02817113 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2016-06
Primary completion
2018-09
Completion
2018-09

Outcome

Outcome not reported

Stopped (Business): “Strategy change”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 —
Subject NC-6004 Other / unclassified — —
Subject fluorouracil Small molecule 1000 mg/m2 —