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

Betta Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Nasopharyngeal Carcinoma

Treatments

Drug: Icotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT02328261

BD-IC-IV21

Details and patient eligibility

About

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

Full 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).

Enrollment

66 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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