UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036606
Receipt No. R000041556
Scientific Title Multicenter PK PD Study of Immune Checkpoint Inhibitors for Patients Aged 75 or Older with Advanced Non Small Cell Lung Cancer.
Date of disclosure of the study information 2019/04/26
Last modified on 2019/04/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title PK/PD study of Pembrolizumab
Acronym PK/PD study of Pembrolizumab
Scientific Title Multicenter PK PD Study of Immune Checkpoint Inhibitors for Patients Aged 75 or Older with Advanced Non Small Cell Lung Cancer.
Scientific Title:Acronym Elderly Pembro trial
Region
Japan

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

Objectives
Narrative objectives1 Analyses for K/PD/PGX, efficacy & safety, and biomarker in elderly patients with non-small cell lung cancer treated with pembrolizumab.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Pharmacokinetics of pembrolizumab
Key secondary outcomes 1)Responce rate
2)Disease control rate
3)Progression free survival
4)Overall survival
5)Adverse event
6)PK/PD/PGx
7)Biomarker

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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Histlogically or cytologically confirmed EGFR mutation positive non small cell lung cancer(NSCLC)
2)Patients who are going to treat with Pembrolizumab monotherapy or combination therapy.
3)No object about organ function, prior treatment, performance status, or measurable lesion.
4)More than 75 years old
5)Written informed consent
Key exclusion criteria 1)Patients who have treated with Pembrolizumab
2)Patients who denied to collect sample
3)Patients whose attending doctor consider as inappropriate for this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Akinobu
Middle name
Last name Hamada
Organization National Cancer Center Research Institute
Division name Division of Molecular Pharmacology
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL 03-3542-2511
Email akhamad@ncc.go.jp

Public contact
Name of contact person
1st name Shigehiro
Middle name
Last name Yagishita
Organization National Cancer Center Research Institute
Division name Division of Molecular Pharmacology
Zip code 104-0045
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN
TEL 03-3542-2511
Homepage URL
Email syagishi@ncc.go.jp

Sponsor
Institute National Cancer Center Research Institute
Division of Molecular Pharmacology
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Cancer Center
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, JAPAN
Tel 03-3542-2511
Email syagishi@ncc.go.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
2019 Year 04 Month 26 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 04 Day
Date of IRB
2019 Year 03 Month 25 Day
Anticipated trial start date
2019 Year 03 Month 25 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Efficacy, safety, PK/PD/PGx, and biomarker study for elderly patients with non-small cell lung cancer treated with pembrolizumab.

Management information
Registered date
2019 Year 04 Month 26 Day
Last modified on
2019 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041556

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.