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

Phase 4

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Nimotuzumab Injection

• Registration Number: NCT02293356
• Lead Sponsor: Biotech Pharmaceutical Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2014-10-31
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-18
• Status Verified: 2015-08
• Study Start: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab Injection	Nimotuzumab Injection	200mg,Once a week，Intravenous infusion over 60 minutes

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cancer Institute & Hospital.Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China