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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma: A Phase II, Multi-center, Open-label Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02328261
• Other study ID #: BD-IC-IV21
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 24, 2014
• Last updated: December 26, 2014
• Start date: November 2014
• Est. completion date: April 2017

Study information

• Verified date: November 2014
• Source: Betta Pharmaceuticals Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• Icotinib
Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co.,Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control rate(DCR)		At least 8 weeks	No
Secondary	Progression-free survival		At least 8 weeks	No