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

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A Study of a PD-1/CTLA-4 Bispecific Antibody AK104 in Patients With Metastatic Nasopharyngeal Carcinoma Study of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes (CTL) Maintenance Chemotherapy in High-metastatic Risk Nasopharyngeal Carcinoma Patients of N3 Stage Nimotuzumab Combined With VMAT in Elderly Patients With Nasopharyngeal Carcinoma Bintrafusp Alfa in Previously Treated Patients With Recurrent and Metastatic (R/M) Non-keratinizing Nasopharyngeal Carcinoma (NPC) Concurrent Chemotherapy for Recurrent T3/T4 Nasopharyngeal Carcinoma Weekly Plasma EBV DNA for Non-metastatic Nasopharyngeal Carcinoma Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T Lymphocytes Intensity-modulated Radiation Therapy Combined With Cisplatin or Nedaplatin Chemotherapy in Nasopharyngeal Carcinoma MK-2206 in Recurrent Nasopharyngeal Carcinoma Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma Prospective Comparisons of Clinical Trial and Real-world 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Trail Evaluating Carbon Ion Radiotherapy (3 GyE Per Fraction) for Locally Recurrent Nasopharyngeal Carcinoma Intestinal Flora Sequencing for Nasopharyngeal Carcinoma Trial Evaluating Carbon Ion Radiotherapy With Concurrent Chemotherapy for Locally Recurrent Nasopharyngeal Carcinoma Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy Molecular Genetics Study of Nasopharyngeal Carcinoma: Characterization of NCP Susceptibility Gene(s) Induction Chemotherapy of TPX in Nomogram-predicted High Risk Locoregionally Advanced Nasopharyngeal Carcinoma Apatinib Combined With PD-1 in the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma Induction Chemotherapy With GP Versus TPF in the Treatment of Advanced Nasopharyngeal Carcinoma Late-Course Accelerated Hyperfractionated IMRT for Locoregionally Advanced Nasopharyngeal Carcinoma Induction Chemotherapy With Nab-paclitaxel, Cisplatin and Fluorouracil for Locoregionally Advanced Nasopharyngeal Carcinoma Phase III 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Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma Concurrent Chemoradiotherapy With Nimotuzumab for High Risk Nasopharyngeal Carcinoma Recurrent Nasopharyngeal Cancer: the Effect of Surgery vs IMRT Reduced-dose Radiotherapy for Low-risk Stage III Patients With Nasopharyngeal Carcinoma Autologous Stem Cell Transplantation for Patients With Recurrent Nasopharyngeal Carcinoma Post-treatment Ultrasensitive Positron Emission Tomography in Nasopharyngeal Carcinoma Patients Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma Late Sequelae of Childhood and Adolescent Nasopharyngeal Carcinoma Survivors After Radiotherapy Photon/Proton Radiation Therapy for Carcinoma of the Nasopharynx Chemotherapy Plus Subsequent Loco-regional Radiotherapy Combined With Toripalimab in the De Novo 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Brief Title

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

Official Title

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

Brief Summary

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

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Disease control rate(DCR)

Secondary Outcome

 Progression-free survival

Condition

Nasopharyngeal Carcinoma

Intervention

Icotinib

Study Arms / Comparison Groups

 Icotinib
Description:  Icotinib (125 mg tablet) is orally administered three times daily

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

66

Start Date

November 2014

Completion Date

April 2017

Primary Completion Date

October 2016

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Xiaohua Hu, MD, ,

Administrative Informations

NCT ID

NCT02328261

Organization ID

BD-IC-IV21

Responsible Party

Sponsor

Study Sponsor

Betta Pharmaceuticals Co., Ltd.

Study Sponsor

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

Verification Date

November 2014