Overview

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