UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032489
Receipt No. R000037050
Scientific Title Biomarker study for afatinib plus bevacizimab
Date of disclosure of the study information 2018/05/07
Last modified on 2019/05/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email kohashi@cc.okayama-u.ac.jp

Sponsor
Institute Okayama University
Institute
Department

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
Email 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 Open public 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
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037050

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.