UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for Non-Small Cell Lung Cancer
Title of the study (Brief title)	Dose-escalation Study of Afatinib in Elderly Patients with EGFR mutation for 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	To investigate feasibility, maximum tolerated dose and recommended phase II dose of afatinib therapy in elderly patients with EGFR mutation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	To conclude maximum tolerated dose and recommended phase II dose.
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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Histologically or cytologically proven non-small cell lung cancer 2)Harboring sensitive EGFR mutation 3)More taan 3 weeks from prior chomotherapy 4)More than 12 weeks from the RT therapy 5)More than 2 weeks from pleurodesis 6)Performance status: 0-1 7)More than 75 years old 8)Adequate organ functions 9)PaO2 >= 60torr or SpO2 >= 95% at room air 10)Life expectancy: over 3 months 11)Written informed consent
Key exclusion criteria	1)Having severe complications 2)Symptomatic brain metastases 3)Interstitial pneumonitis on chest Xray 4)Past history of severe allergic reactions to drugs 5)Pregnant or breastfeeding woman 6)Receiving steroids or immunosuppressants 7)Active infectious disease 8)Uncontrollable pleural effusion or pericardial effusion 9)Active double cancer 10)Patients whose physicians considered as inappropriate for this clinical study
Target sample size	18

Research contact person
Name of lead principal investigator	Kageaki Taima
Organization	Hirosaki University Graduate School of Medicine
Division name	Cardiology, Respiratory medicine and Nephrology
Address	5 Zaifu-cho Hirosaki city, Aomori Prefecture, JAPAN
TEL	0172-39-5057
Email	taima0305@hotmail.com

Public contact
Name of contact person	Hisashi Tanaka
Organization	Hirosaki University Graduate School of Medicine
Division name	Cardiology, Respiratory medicine and Nephrology
Address	5 Zaifu-cho Hirosaki city, Aomori Prefecture, JAPAN
TEL	0172-39-5057
Homepage URL
Email	xyghx335@gmail.com

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2015 Year 02 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 06 Day
Anticipated trial start date	2015 Year 02 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 04 Day
Last modified on	2018 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019088