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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031845
Receipt No. R000036359
Scientific Title Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Date of disclosure of the study information 2018/03/22
Last modified on 2020/09/25

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Basic information
Public title Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Acronym Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Scientific Title Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Scientific Title:Acronym Prospective study to investigate the resistant mechanism to afatinib treatment in EGFR mutation-positive non-small cell lung cancer
Region
Japan

Condition
Condition Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the factor of resistance to afatinib in EGFR gene mutation positive NSCLC. To investigate the frequency of T790M mutation and concordance rate between blood and tumor tissue at PD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The frequency of T790M mutation and concordance rate between blood and tumor tissue at PD
Key secondary outcomes 1) PFS
2) ORR
3) TTF
4) OS
5) Safety
6) The correlation between blood concentration of afatinib and safety

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 40mg/day
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) Patients with NSCLC with a histological diagnosis or cytodiagnosis
2) Patients with EGFR gene mutation
3) Patients with unresectable advanced case
4) Patients that 14 days pass from the last dosage of systemic chemotherapy
5) Patients with more than 20 years old
6) Patients with ECOG PS 0,1,2
7) Patients harboring a more than one measurable lesion
8) Patients that expected survival time is more than 2 months
9) Patients with adequate organ function
Neutrophil >= 1500/mm3
Platelet >= 100,000/mm3
Hemoglobin >= 8.0g/dl
AST,ALT <=2.5 x ULN
Total bilirubin <= 2mg/dl
10) Patients providing written informed consent
Key exclusion criteria 1) Patients with interstitial pneumonitis or pulmonary fibrosis
2) Patients with serious infection
3) Patients with unsteady angina or cardiac infarction
4) Patients with severe complication
5) Patients with active double cancer
6) Patients requiring medication influenced P glycoprotein
7) Patients with history of dosage afatinib
8) Patients with contraindication against afatinib
9) Patients with history of serious hypersensitivity or allergy
10) Pregnant, pregnancy suspect, nursing women, patients who plan to have a baby
11) Patients with complication with mental disease or a mind symptom, and are judged to have difficulty in participation in the study
12) Any other patients who are regarded as unsuitable for this study by the investigators
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Keiko
Middle name
Last name Mizuno
Organization Kagoshima University Hospital
Division name Department of Pulmonary medicine
Zip code 890-8520
Address 8-35-1, Sakuragaoka, Kagoshima-city
TEL 99-275-5111
Email keim@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name Keiko
Middle name
Last name Mizuno
Organization Kagoshima University Hospital
Division name Department of Pulmonary medicine
Zip code 890-8520
Address 8-35-1, Sakuragaoka, Kagoshima-city
TEL 099-275-5111
Homepage URL
Email keim@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University Hospital
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Ethics Committee on Clinical Research, Kagoshima University Hospital
Address 8-35-1, Sakuragaoka, Kagoshima-city
Tel 099-275-5111
Email kufsyomu@kuas.kagoshima-u.ac.jp

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 鹿児島大学病院(鹿児島県)
川内市医師会立市民病院(鹿児島県)
南九州病院(鹿児島県)
鹿児島市立病院(鹿児島県)
鹿児島厚生連病院(鹿児島県)
今給黎総合病院(鹿児島県)
南風病院(鹿児島県)
鹿児島県立北薩病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 26
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 Completed
Date of protocol fixation
2017 Year 02 Month 24 Day
Date of IRB
2017 Year 09 Month 15 Day
Anticipated trial start date
2017 Year 09 Month 15 Day
Last follow-up date
2020 Year 08 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 22 Day
Last modified on
2020 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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