UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032489 |
|---|---|
| Receipt number | R000037050 |
| Scientific Title | Biomarker study for afatinib plus bevacizimab |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2021/05/10 08:32:26 |
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Basic information
Public title
Biomarker study for afatinib plus bevacizimab
Acronym
Biomarker study for afatinib plus bevacizimab
Scientific Title
Biomarker study for afatinib plus bevacizimab
Scientific Title:Acronym
Biomarker study for afatinib plus bevacizimab
Region
| Japan |
Condition
Condition
Non-small cell lung cancer with EGFR mutations
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The frequency of development ofEGFR T790M between afatainib arm and afatinib/Bev arm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of development ofEGFR T790M between afatainib arm and afatinib/Bev arm
Key secondary outcomes
The effect of afatiib or afatinib/Bev based on EGFR T790M status
The effect of subsequent therapies including osimertinib
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
The patients must be enrolled in UMIN000027432
Key exclusion criteria
nothing in particular
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuyuki |
| Middle name | |
| Last name | KIURA |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
7008558
Address
086-235-7227
TEL
086-235-7227
kkiura@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kadoaki |
| Middle name | |
| Last name | OHASHI |
Organization
Okayama University Hospital
Division name
Department of Respiratory Medicine
Zip code
7008558
Address
086-235-7227
TEL
086-235-7227
Homepage URL
kohashi@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Boehringer Ingerheim
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
Okayama University
Address
2-5-1, Shikata-cho, Kita-Ward, Okayama
Tel
086-235-6938
mae6605@adm.okayama-u.ac.j
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
| 2018 | Year | 05 | Month | 07 | 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
| 2018 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 02 | 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
Nothing in particular
Management information
Registered date
| 2018 | Year | 05 | Month | 07 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037050
| 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 |
