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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328261
Recruitment Status : Unknown
Verified November 2014 by Betta Pharmaceuticals Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Betta Pharmaceuticals Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Icotinib Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma: A Phase II, Multi-center, Open-label Study
Study Start Date : November 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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 Name: Conmana




Primary Outcome Measures :
  1. Disease control rate(DCR) [ Time Frame: At least 8 weeks ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: At least 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328261


Sponsors and Collaborators
Betta Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Xiaohua Hu, MD The first affliated hospital of Guangxi medical university
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Responsible Party: Betta Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT02328261    
Other Study ID Numbers: BD-IC-IV21
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases