UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046465 |
|---|---|
| Receipt number | R000053015 |
| Scientific Title | Drug Use-results Survey of TEPMETKO tablets 250 mg (METex14 skipping alterations, unresectable, advanced or recurrent non-small cell lung cancer) |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2023/09/13 08:40:24 |
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Basic information
Public title
Drug Use-results Survey of TEPMETKO tablets 250 mg
(METex14 skipping alterations, unresectable, advanced or recurrent non-small cell lung cancer)
Acronym
TEPMETKO 250 mg Investigation (Non-small cell lung cancer)
Scientific Title
Drug Use-results Survey of TEPMETKO tablets 250 mg
(METex14 skipping alterations, unresectable, advanced or recurrent non-small cell lung cancer)
Scientific Title:Acronym
TEPMETKO 250 mg Investigation (Non-small cell lung cancer)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Under the condition for approval, a survey is conducted to further characterize the safety in patients with METex14 skipping alterations, unresectable, advanced or recurrent non-small cell lung cancer after administration of TEPMETKO Tablets 250 mg under real-world clinical practice settings.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate occurrence of interstitial lung disease, fluid retention, hepatic function disorder, renal impairment and QT interval prolongation
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
All patients who received at least 1 dose of this drug during the survey period.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Momo |
Organization
Merck Biopharma Co., Ltd.
Division name
PMS Planning & Strategy
Zip code
153-8926
Address
Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo
TEL
03-6756-0791
hidehiko.momo@merckgroup.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ogura |
Organization
Merck Biopharma Co., Ltd.
Division name
PMS Planning & Strategy
Zip code
153-8926
Address
Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo
TEL
03-6756-0791
Homepage URL
tatsuya.ogura@merckgroup.com
Sponsor or person
Institute
Merck Biopharma Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Merck Biopharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Merck Biopharma Co., Ltd.
Address
Arco Tower 4F, 1-8-1 Shimomeguro, Meguro-ku, Tokyo
Tel
0367560791
tatsuya.ogura@merckgroup.com
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
| 2021 | Year | 12 | Month | 24 | 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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2023 | 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=R000053015
