This trial is active, not recruiting.

Condition nasopharyngeal carcinoma
Treatment icotinib
Phase phase 2
Target EGFR
Sponsor Betta Pharmaceuticals Co.,Ltd.
Start date November 2014
End date October 2016
Trial size 66 participants
Trial identifier NCT02328261, BD-IC-IV21


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Icotinib (125 mg tablet) is orally administered three times daily
icotinib Conmana
Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.

Primary Outcomes

Disease control rate(DCR)
time frame: At least 8 weeks

Secondary Outcomes

Progression-free survival
time frame: At least 8 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma: A Phase II, Multi-center, Open-label Study
Principal investigator Xiaohua Hu, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Betta Pharmaceuticals Co.,Ltd..