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 UMIN000024476
Receipt No. R000028172
Scientific Title Resistant mechanisms to afatinib in non-small cell lung cancer with EGFR mutations
Date of disclosure of the study information 2016/10/19
Last modified on 2016/10/19

* 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 Resistant mechanisms to afatinib in non-small cell lung cancer with EGFR mutations
Acronym Resistant mechanisms to afatinib
Scientific Title Resistant mechanisms to afatinib in non-small cell lung cancer with EGFR mutations
Scientific Title:Acronym Resistant mechanisms to afatinib
Region
Japan

Condition
Condition Non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To clarify the detection rate of T790M mutation in cfDNA from patients with resistance to afatinib
Basic objectives2 Others
Basic objectives -Others search for biomarkars
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection of T790M mutation in cfDNA
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 afatinib
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)Histologically or cytologically confirmed non-small cell lung cancer patients
2)Patients with EGFR mutation
3)Patients treated with afatinib, or who have a planned treatment with afatinib
4)Blood sampling at resistance to afatinib
5)Patients who are considered to survive for more than 3 months
6)Written informed consent
7)Patients aged 20 years or older
Key exclusion criteria 1)Patients with active double or multifocal cancers
2)Patients whose lesions are hard to evaluate
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kasahara
Organization kanazawa University Graduate School of Medical Sciences
Division name Respiratory Medicine
Zip code
Address 13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL 076-265-2273
Email k-kasa@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideharu Kimura
Organization Kanazawa University Hospital
Division name Respiratory Medicine
Zip code
Address 13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL 076-265-2273
Homepage URL
Email hkimura3625@staff.kanazawa-u.ac.jp

Sponsor
Institute Respiratory Medicine, Kanazawa University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 10 Month 19 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
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 19 Day
Last modified on
2016 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028172

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.