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
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)
Condition
Nasopharyngeal Carcinoma
Intervention
Nimotuzumab Injection
Study Arms / Comparison Groups
Nimotuzumab Injection
Description: 200mg,Once a week，Intravenous infusion over 60 minutes
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
2000
Start Date
August 2015
Completion Date
December 2017
Primary Completion Date
December 2017
Eligibility Criteria
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
li gao, PhD, 13801371743, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02293356
Organization ID
BPL-Nim-NPC-2
Responsible Party
Sponsor
Study Sponsor
Biotech Pharmaceutical Co., Ltd.
Study Sponsor
li gao, PhD, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Verification Date
August 2015