drugset / Trial / NCT02817113
Study of NC-6004 in Combination With 5-FU and Cetuximab in Patients With Head and Neck Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | 250 mg/m2 | — |
| Subject | NC-6004 | Other / unclassified | — | — |
| Subject | fluorouracil | Small molecule | 1000 mg/m2 | — |