drugset / Trial / NCT00519077

Phase II Study of Skin Toxicity Dosing of IRESSA (Gefitinib) in Squamous Cell Carcinoma of the Head and Neck

NCT00519077 ↗

Phase 2 Completed 44 enrolled University of Chicago AstraZeneca · collab
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to demonstrate the activity (response rate and rate of stable disease) of Iressa administered as a single agent escalated to a dose that produces grade 2 skin toxicity in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Timeline

Start
2005-03
Primary completion
2008-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Gefitinib Small molecule 250 mg Oral
Subject Gefitinib Small molecule 500 mg Oral
Subject Gefitinib Small molecule 750 mg Oral