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

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.; Betta Pharmaceuticals Co.,Ltd.

Criteria

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