ClinicalTrials.Veeva

Menu

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

B

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

66 participants in 1 patient group

Icotinib
Experimental group
Description:
Icotinib (125 mg tablet) is orally administered three times daily
Treatment:
Drug: Icotinib

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems