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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Icotinib
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Icotinib

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Disease control rate(DCR)

    Secondary Outcome Measures

    Progression-free survival

    Full Information

    First Posted
    November 24, 2014
    Last Updated
    December 26, 2014
    Sponsor
    Betta Pharmaceuticals Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02328261
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2014 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    April 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Betta Pharmaceuticals Co., Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Nasopharyngeal Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Icotinib
    Arm Type
    Experimental
    Arm Description
    Icotinib (125 mg tablet) is orally administered three times daily
    Intervention Type
    Drug
    Intervention Name(s)
    Icotinib
    Other Intervention Name(s)
    Conmana
    Intervention Description
    Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.
    Primary Outcome Measure Information:
    Title
    Disease control rate(DCR)
    Time Frame
    At least 8 weeks
    Secondary Outcome Measure Information:
    Title
    Progression-free survival
    Time Frame
    At least 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiaohua Hu, MD
    Organizational Affiliation
    The first affliated hospital of Guangxi medical university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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