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

December 26, 2014 updated by: Betta Pharmaceuticals Co., Ltd.

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Icotinib
Icotinib (125 mg tablet) is orally administered three times daily
Drug: Icotinib
Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.
Other Names:
  • Conmana

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease control rate(DCR)
Time Frame: At least 8 weeks
At least 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival
Time Frame: At least 8 weeks
At least 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betta Pharmaceuticals Co., Ltd.

Investigators

  • Principal Investigator: Xiaohua Hu, MD, The first affliated hospital of Guangxi medical university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

December 26, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 26, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BD-IC-IV21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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