Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
1 other identifier
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 18, 2014
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedAugust 19, 2015
August 1, 2015
2.3 years
October 31, 2014
August 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)
up to 30 months
Study Arms (1)
Nimotuzumab Injection
EXPERIMENTAL200mg,Once a week，Intravenous infusion over 60 minutes
Interventions
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.
Eligibility Criteria
You may qualify if:
- Patients with histologically or cytologically confirmed nasopharyngeal carcinoma
- Sex and age without limiting
- Treatment without limiting
- Subjects with reproductive potential (males and females) willing to use reliable means of contraception
- Able and willing to give written informed consent and comply with the requirements of the study protocol
You may not qualify if:
- Patients with severe allergies or idiosyncratic constitution
- Women who are pregnant (determined by urine pregnancy test)or breast feeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Institute & Hospital.Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
li gao, PhD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2014
First Posted
November 18, 2014
Study Start
August 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
August 19, 2015
Record last verified: 2015-08