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