UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028922 |
|---|---|
| Receipt number | R000032958 |
| Scientific Title | Pharmacokinetic study of osimertinib in NSCLC patients with body fluid |
| Date of disclosure of the study information | 2017/09/15 |
| Last modified on | 2024/09/13 19:03:06 |
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Basic information
Public title
Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Acronym
Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Scientific Title
Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Scientific Title:Acronym
Pharmacokinetic study of osimertinib in NSCLC patients with body fluid
Region
| Japan |
Condition
Condition
Advanced non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the relation between malignant effusion and concentration of osimertinib in patients with non-small cell lung cancer
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association of malignant effusion with osimertinib exposure in non-small cell lung cancer
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathologically confirmation of non small cell lung cancer
2) The history of EGFR-TKI therapies
3) Detected T790M mutation by rebiopsy samples
4) Administration of osimertinib is planned or ongoing
5) At least one or more measurable lesion by RESIST (Version1.1) (patients who have only pleural effusion are eligible)
6) Aged 20 or more
7) Written informed consent
Key exclusion criteria
Patients with interstitial pneumonitis identified by chest X-ray
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Takahashi |
Organization
Shizuoka cancer center
Division name
Devision of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL
(+81)055-989-5222
t.takahashi@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Kawamura/ Kenmotsu Hirotsugu |
Organization
Shizuoka cancer center
Division name
Devision of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL
(+81)055-989-5222
Homepage URL
ta.kawamura@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
Shizuoka cancer center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
1) Pharmaceutics, school of medicine, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 09 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted to evaluate the relation between malignant effusion and concentration of osimertinib in patients with non-small cell lung cancer
Management information
Registered date
| 2017 | Year | 08 | Month | 31 | Day |
Last modified on
| 2024 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032958
