Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer
Status:
Completed
Trial end date:
2013-10-01
Target enrollment:
Participant gender:
Summary
This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin
and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a
multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human
epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is
designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101
when administered in combination with concurrent cisplatin and radiation over an 8-week
treatment course, consisting of a one week run-in period of CUDC-101 administered alone,
followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation
therapy.