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

NCT ID: NCT02328261

Last Updated: 2014-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-04-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Icotinib

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

Group Type EXPERIMENTAL

Icotinib

Intervention Type DRUG

Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.

Interventions

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Icotinib

Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.

Intervention Type DRUG

Other Intervention Names

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Conmana

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaohua Hu, MD

Role: PRINCIPAL_INVESTIGATOR

The first affliated hospital of Guangxi medical university

Other Identifiers

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BD-IC-IV21

Identifier Type: -

Identifier Source: org_study_id