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

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Icotinib

• Registration Number: NCT02328261
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

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

Detailed Description

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).

Study Timeline

• Status Verified: 2014-11
• Study Start: 2014-11
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-12-26
• Last Update Submitted: 2014-12-26
• Study First Posted: 2014-12-31
• Last Update Posted: 2014-12-31
• Primary Completion: 2016-10
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Icotinib	Icotinib	Icotinib (125 mg tablet) is orally administered three times daily

Primary Outcome Measures

Name	Time	Method
Disease control rate(DCR)	At least 8 weeks

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	At least 8 weeks