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

August 18, 2015 updated by: Biotech Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Institute & Hospital.Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Nimotuzumab Injection
200mg,Once a week，Intravenous infusion over 60 minutes
Drug: Nimotuzumab Injection
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.
Other Names:
  • Taixinsheng

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)
Time Frame: up to 30 months
up to 30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biotech Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: li gao, PhD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 31, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (ESTIMATE)

November 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPL-Nim-NPC-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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