UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052618 |
|---|---|
| Receipt number | R000056500 |
| Scientific Title | Study on PK/PD of immune checkpoint inhibitors according to differential dosage in elderly non-small cell lung cancer patients |
| Date of disclosure of the study information | 2023/10/26 |
| Last modified on | 2023/10/26 12:59:05 |
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Basic information
Public title
Study on PK/PD of immune checkpoint inhibitors according to differential dosage in elderly non-small cell lung cancer patients
Acronym
Pharmacokinetic studies of pembrolizumab
Scientific Title
Study on PK/PD of immune checkpoint inhibitors according to differential dosage in elderly non-small cell lung cancer patients
Scientific Title:Acronym
Study on PK and PD of pembrolizumab
Region
| Japan |
Condition
Condition
relapse or advanced non-small cell lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Pharmacokinetics (PK) and pharmacodynamics (PD) analyses of pembrolizumab (200 mg or 400 mg) in patients with non-small cell lung cancer (NSCLC) treated with pembrolizumab (Keytruda) will be conducted. PK/PD analysis of pembrolizumab will be performed in a prospective, observational study to investigate the association between age and dose with the frequency of irAEs and treatment response.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics analysis of pembrolizumab
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Blood samples will be collected before the first cycle of pembrolizumab administration, at the end of administration, 2 hours after the start of administration, 6 hours after the start of administration, 24 hours after the start of administration, before the second cycle of administration, before the fourth cycle of administration, before any of the first 6-8 cycles of administration, at the onset of an immune-related adverse event, and at the time of recovery from an immune-related adverse event. A maximum of 10 blood samples will be taken.
Interventions/Control_2
Blood samples will be collected before the first cycle of pembrolizumab administration, at the end of administration, before the second cycle of administration, before the fourth cycle of administration, before any of the first 6-8 cycles of administration, at the onset of an immune-related adverse event, and at the time of recovery from an immune-related adverse event. A maximum of 7 blood samples will be taken.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients (adults 18 years and older) with histologically or cytologically diagnosed NSCLC
2)Patients with either of the following.
(1) Patients who are scheduled to receive treatment with pembrolizumab (either 200 mg or 400 mg as a single agent or in combination with chemotherapy).
(2) Patients who are already receiving pembrolizumab treatment (200 mg) and are considering switching to 400 mg.
3)Patients who have given written consent to participate in this study.
Key exclusion criteria
1) Patients who cannot give consent for specimen collection.
2) Patients who are judged by the principal investigator or the physician in charge to be inappropriate as subjects for this study.
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yuichiro |
| Middle name | |
| Last name | Ohe |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji,Chuo-ku,Tokyo
TEL
03-3542-2511
yohe@ncc.go.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Yoshida |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Thoracic Oncology
Zip code
104-0045
Address
5-1-1 Tsukiji,Chuo-ku,Tokyo
TEL
03-3542-2511
Homepage URL
tayoshi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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 Hospital, Japan
Address
5-1-1 Tsukiji,Chuo-ku,Tokyo
Tel
03-3542-2511
chuo-rinrishinsa@dl.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
| 2023 | Year | 10 | 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
| 2023 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056500
