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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Nimotuzumab Injection Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 Name: Taixinsheng




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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Li gao, PhD 13801371743 li_gao2008@yahoo.com.cn

Locations
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China, Beijing
Cancer Institute & Hospital.Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: li gao, PhD    13801371743    li_gao2008@yahoo.com.cn   
Sponsors and Collaborators
Biotech Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: li gao, PhD Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: Biotech Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02293356     History of Changes
Other Study ID Numbers: BPL-Nim-NPC-2
First Posted: November 18, 2014    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Nimotuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents