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Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab Injection
Sponsored by
Biotech Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with histologically or cytologically confirmed nasopharyngeal carcinoma
  2. Sex and age without limiting
  3. Treatment without limiting
  4. Subjects with reproductive potential (males and females) willing to use reliable means of contraception
  5. Able and willing to give written informed consent and comply with the requirements of the study protocol

Exclusion Criteria:

  1. Patients with severe allergies or idiosyncratic constitution
  2. Women who are pregnant (determined by urine pregnancy test)or breast feeding
  3. Any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view

Sites / Locations

  • Cancer Institute & Hospital.Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nimotuzumab Injection

Arm Description

200mg,Once a week，Intravenous infusion over 60 minutes

Outcomes

Primary Outcome Measures

To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)

Secondary Outcome Measures

Full Information

First Posted
October 31, 2014
Last Updated
August 18, 2015
Sponsor
Biotech Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02293356
Brief Title
Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
Official Title
Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotech Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.
Detailed Description
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs. Subjects who meet the inclusion/exclusion criteria are administered of Nimotuzumab based on medication instructions or adjusted by clinicians according to the treatment. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of Nimotuzumab is stopped.

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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nimotuzumab Injection
Arm Type
Experimental
Arm Description
200mg,Once a week，Intravenous infusion over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Nimotuzumab Injection
Other Intervention Name(s)
Taixinsheng
Intervention Description
patients receive nimotuzumab injection for 200mg/w,intravenous infusion over 60 minutes.Doctor adjust the dosage of nimotuzumab and choose other treatment options according to the actual situation of patients.
Primary Outcome Measure Information:
Title
To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)
Time Frame
up to 30 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with histologically or cytologically confirmed nasopharyngeal carcinoma Sex and age without limiting Treatment without limiting Subjects with reproductive potential (males and females) willing to use reliable means of contraception Able and willing to give written informed consent and comply with the requirements of the study protocol Exclusion Criteria: Patients with severe allergies or idiosyncratic constitution Women who are pregnant (determined by urine pregnancy test)or breast feeding Any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li gao, PhD
Phone
13801371743
Email
li_gao2008@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
li gao, PhD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Institute & Hospital.Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
li gao, PhD
Phone
13801371743
Email
li_gao2008@yahoo.com.cn

12. IPD Sharing Statement

Learn more about this trial

Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma

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