Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT02293356|
Recruitment Status : Unknown
Verified August 2015 by Biotech Pharmaceutical Co., Ltd..
Recruitment status was: Recruiting
First Posted : November 18, 2014
Last Update Posted : August 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: Nimotuzumab Injection||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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 Name: Taixinsheng
- To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03) [ Time Frame: up to 30 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02293356
|Contact: Li gao, PhDfirstname.lastname@example.org|
|Cancer Institute & Hospital.Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: li gao, PhD 13801371743 email@example.com|
|Principal Investigator:||li gao, PhD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|