A Phase 1 Dose Escalation Study of GC4419 in Combination With Chemoradiation for Squamous Cell Cancer of the Head & Neck
Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to determine the safety, tolerability, and the highest dose of
GC4419 that can be given to patients with squamous cell cancer of the head and neck who are
receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419
for the following:
- Effect on the incidence and severity of radiation induced oral mucositis;
- Effect on the response rate of squamous cell cancer of the head and neck who are
receiving radiation therapy and chemotherapy;
- Total concentrations of GC4419 that can be achieved in the blood;
- Changes in proteins and genetics associated with oral mucositis;
- Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open
the mouth);
- Observe changes in genetic and molecular markers of oral mucositis;
- Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube
use, etc.) of study patients;
- Assess the overall quality of life in study patients with oral mucositis.