Unique ID issued by UMIN | UMIN000041082 |
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Receipt number | R000046916 |
Scientific Title | Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer |
Date of disclosure of the study information | 2020/07/13 |
Last modified on | 2020/07/13 10:09:40 |
Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Japan |
Non-small-cell lung cancer, renal cell cancer
Pneumology | Urology |
Malignancy
YES
This study evaluates the interindividual variability of serum nivolumab disposition determined by LC-MS/MS and nivolumab-related adverse events by investigating the patient background, concentration of serum proteins related with nivolumab, and genetic variants of antibody receptor transporters.
PK,PD
Serum nivolumab concentration just before dosing at 7th administration or later
Observational
Not applicable |
Not applicable |
Male and Female
1. Patients treated with intravenous nivolumab for non-small-cell lung cancer or renal cell cancer
2. Patients receiving written informed consent
Patients who are judged by physicians as inappropriate for study enrollment
100
1st name | Junichi |
Middle name | |
Last name | Kawakami |
Hamamatsu University School of Medicine
Department of Hospital pharmacy
4313192
1-20-1 Handayama, Hamamatsu 431-3192
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
4313192
1-20-1 Handayama, Hamamatsu 431-3192
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
Ethics Committee of Hamamatsu University School of Medicine
1-20-1 Handayama, Hamamatsu 431-3192
053-435-2111
rinri@hama-med.ac.jp
NO
2020 | Year | 07 | Month | 13 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 11 | Month | 21 | Day |
2017 | Year | 12 | Month | 28 | Day |
2018 | Year | 01 | Month | 08 | Day |
2023 | Year | 01 | Month | 31 | Day |
Study design: Observational study
Object recruitment: All patients who visit our hospital and meet the selection criteria from January 2018 to 2023
Primary outcome: Serum nivlumab concentration just before dosing at 7th administration or later
Secondary outcome:
1. Serum concentrations of total protein, albumin, and immunoglobulins
2. Concomitant drug
3. Serum concentrations of inflammatory cytokines and immune complex
4. Cachexia stage
5. Therapeutic efficacy
6. Adverse events and its grade
7. Laboratory values
8. Patient characteristics
9. Anti-nivolumab antibody
10. Serum concentration and genetic variants of PD-1, PD-L1, and L2
2020 | Year | 07 | Month | 13 | Day |
2020 | Year | 07 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046916
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