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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02293356
• Other study ID #: BPL-Nim-NPC-2
• Status: Recruiting
• Phase: Phase 4
• First received: October 31, 2014
• Last updated: August 18, 2015
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2015
• Source: Biotech Pharmaceutical Co., Ltd.
• Contact: Li gao, PhD
• Phone: 13801371743
• Email: li_gao2008[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationChina: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Institute & Hospital.Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)		up to 30 months	Yes