A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma

Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma: A Phase II, Multi-center, Open-label Study

This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with advanced nasopharyngeal carcinoma.

This phase 2 study is aimed to evaluate the efficacy of single-agent icotinib in patients with pretreated, advanced nasopharyngeal carcinoma. The primary endpoint is disease control rate (DCR).

Inclusion Criteria:

• Histologically confirmed advanced NPC
• Patients must be platinum-resistant defined as recurrence or progression of disease <6 months since previous treatment with a platinum based treatment regimen.
• Measurable disease per RECIST
• Adequate organ and marrow function
• Capable of understanding and complying with the protocol, and written informed consent

Exclusion Criteria:

• Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR
• Patients must not be receiving any other investigational agents
• Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
• Women who are pregnant or breast-feeding