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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027016
Receipt No. R000030713
Scientific Title Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Date of disclosure of the study information 2017/04/18
Last modified on 2017/04/17

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Basic information
Public title Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Acronym Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Scientific Title Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Scientific Title:Acronym Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Gastrointestinal surgery Oto-rhino-laryngology Oral surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study evaluates the interindividual variability of serum cetuximab disposition determined by LC-MS/MS and clinical responses to cetuximab by investigating the patient background, concentration of serum proteins related with cetuximab, and genetic variants of antibody receptor transporters.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum concentration of cetuximab before dosing on week 4 or later
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients treated with intravenous cetuximab for head and neck cancer
2. Patients receiving written informed consent
Key exclusion criteria 1. Patients discontinuing intravenous cetuximab
2. Patients who are judged by physicians as inappropriate for study enrollment
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code
Address 1-20-1 Handayama, Hamamatsu 431-3192
TEL 053-435-2763
Email pharmacyham-adm@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takafumi Naito
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code
Address 1-20-1 Handayama, Hamamatsu 431-3192
TEL 053-435-2763
Homepage URL
Email pharmacyham-adm@umin.ac.jp

Sponsor
Institute Department of Hospital pharmacy
Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Department of Hospital pharmacy
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Observational study
Object recruitment: All patients who visit our hospital and meet the selection criteria from June 2016 to May 2021
Primary outcome: Serum concentration of cetuximab before dosing on week 4 or later
Secondary outcome:
1. Serum concentrations of anti-cetuximab antibody, soluble EGFR, EGF, and immunoglobulins
2. Genetic variants of FcRn and IgG
3. Serum concentrations of inflammatory cytokines, inflammatory proteins, and immune complex
4. Cachexia stage
5. Therapeutic efficacy
6. Adverse effect
7. Laboratory values

Management information
Registered date
2017 Year 04 Month 17 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030713

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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