UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033301 |
|---|---|
| Receipt number | R000037963 |
| Scientific Title | Pharmacokinetic and dose finding study of osimertinib in patients with impaired renal function and low body weight |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2019/07/06 09:43:50 |
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Basic information
Public title
Pharmacokinetic and dose finding study of osimertinib in patients with impaired renal function and low body weight
Acronym
Clinical pharmacology of osimertinib in patients with impaired renal function and low body weight
Scientific Title
Pharmacokinetic and dose finding study of osimertinib in patients with impaired renal function and low body weight
Scientific Title:Acronym
Clinical pharmacology of osimertinib in patients with impaired renal function and low body weight
Region
| Japan |
Condition
Condition
NSCLC with EGFR mutation
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this phase 1 study is to evaluate the pharmacokinetics and safety of osimertinib in patients with varying degrees of renal function or body weight.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate recommended dose of osimertinib in patients with varying degrees of renal function or body weight.
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
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cohort A, normal
Interventions/Control_2
Cohort B, mild renal dysfunction
Interventions/Control_3
Cohort C, low body weight
Interventions/Control_4
Cohort D, severe renal dysfunction
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Histlogically confirmed NSCLC with EGFR mutation
2. Advanced or metastatic NSCLC
3. Patients are scheduled for treatment with osimertinib therapy.
Key exclusion criteria
1. Patients with severe concomitant disease
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Yamamoto |
Organization
National Cancer Center Hospital
Division name
Department of Experimental Therapeutics
Zip code
104-0045
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
yutakafu@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Fujiwara |
Organization
Mitsui Memorial Hospital
Division name
Department of Respiratory Medicine
Zip code
101-8643
Address
Kanda-Izumicho 1, Chiyoda-ku, Tokyo
TEL
03-3862-9111
Homepage URL
yutakafu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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 Hospital
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel
03-3542-2511
yutakafu@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 | 03 | Month | 31 | 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
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037963
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
