Unique ID issued by UMIN | UMIN000027016 |
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Receipt number | 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 | 2022/10/20 19:04:39 |
Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Investigation of interindividual factors in cetuximab pharmacokinetics and clinical responses in Japanese head and neck cancer patients using LC-MS/MS method
Japan |
head and neck cancer
Gastrointestinal surgery | Oto-rhino-laryngology | Oral surgery |
Malignancy
YES
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.
PK,PD
Serum concentration of cetuximab before dosing on week 4 or later
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients treated with intravenous cetuximab for head and neck cancer
2. Patients receiving written informed consent
1. Patients discontinuing intravenous cetuximab
2. Patients who are judged by physicians as inappropriate for study enrollment
50
1st name | Junichi |
Middle name | |
Last name | Kawakami |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
431-3192
1-20-1 Handayama, Hamamatsu
053-435-2763
pharmacyham-adm@umin.ac.jp
1st name | Takafumi |
Middle name | |
Last name | Naito |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
431-3192
1-20-1 Handayama, Hamamatsu
053-435-2763
pharmacyham-adm@umin.ac.jp
Department of Hospital pharmacy
Hamamatsu University School of Medicine
Department of Hospital pharmacy
Hamamatsu University School of Medicine
Self funding
Clinical Research Review Board of Hamamatsu University School of Medicine
1-20-1 Handayama, Hamamatsu 431-3192
053-435-2111
rinri@hama-med.ac.jp
NO
2017 | Year | 04 | Month | 18 | Day |
Unpublished
Enrolling by invitation
2016 | Year | 06 | Month | 01 | Day |
2016 | Year | 06 | Month | 08 | Day |
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
2017 | Year | 04 | Month | 17 | Day |
2022 | Year | 10 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030713
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