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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041082
Receipt No. 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

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Basic information
Public title Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Acronym Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
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
Scientific Title:Acronym Investigation of interindividual factors in nivolumab pharmacokinetics and adverse events in Japanese patients with non-small-cell lung cancer and renal cell cancer
Region
Japan

Condition
Condition Non-small-cell lung cancer, renal cell cancer
Classification by specialty
Pneumology Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 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.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum nivolumab concentration just before dosing at 7th administration 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 nivolumab for non-small-cell lung cancer or renal cell cancer
2. Patients receiving written informed consent
Key exclusion criteria Patients who are judged by physicians as inappropriate for study enrollment
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Junichi
Middle name
Last name Kawakami
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code 4313192
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 Takafumi
Middle name
Last name Naito
Organization Hamamatsu University School of Medicine
Division name Department of Hospital pharmacy
Zip code 4313192
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 Ethics Committee of Hamamatsu University School of Medicine
Address 1-20-1 Handayama, Hamamatsu 431-3192
Tel 053-435-2111
Email rinri@hama-med.ac.jp

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
2020 Year 07 Month 13 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
2017 Year 11 Month 21 Day
Date of IRB
2017 Year 12 Month 28 Day
Anticipated trial start date
2018 Year 01 Month 08 Day
Last follow-up date
2023 Year 01 Month 31 Day
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 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

Management information
Registered date
2020 Year 07 Month 13 Day
Last modified on
2020 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046916

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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