UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to examine cerebrospinal fluid transitivity and efficacy of afatinib in carcinomatous meningitis patients with non-small cell lung cancer patients harboring EGFR mutation.
Title of the study (Brief title)	A cerebrospinal fluid transitivity identification test of afatinib
Region	Japan

Condition
Condition	carcinomatous meningitis patients with NSCLC harboring EGFR mutation
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Cerebrospinal fluid transitivity confirmation of afatinib in carcinomtous meningitis patients
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Cerebrospinal fluid transitivity of afatinib
Key secondary outcomes	efficacy and safety of afatinib

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. NSCLC, EGFR mutation positive, carcinomatous meningitis patients 2. no treatment of afatinib 3. over 20 years old at the registration 4. ECOG PS 0-3 5. good status of main organ 6. written informed concent
Key exclusion criteria	1. over Grade 2 of diarrhea, a severe gastrointestinal disorder 2. Interstitial lung disease 3. diagnose of malignancy in 5 years 4. Angina and myocardial infarction within six months, heart disorder, severe arrhythmia 5. pleural effusion or ascites which need treatment 6. uncontrolled complications 7. Serious drug allergy history 8. Cannot promise contraception 9. No pregnancy, during nursing 10. A chief physician decide not eligible
Target sample size	10

Research contact person
Name of lead principal investigator	Shinji Atagi
Organization	Kinki-Chuo Chest Medical Center
Division name	Clinical Research Center
Address	1180, Nagasone-cho, Kita-ku, Sakai City, Osaka, JAPAN
TEL	072-252-3-21
Email	s-atagi@kch.hosp.go.jp

Public contact
Name of contact person	Akihiro Tamiya
Organization	Kinki-Chuo Chest Medical Center
Division name	Internal Medicine
Address	1180, Nagasone-cho, Kita-ku, Sakai City, Osaka, JAPAN
TEL	072-252-3021
Homepage URL
Email	atamiya@kch.hiosp.go.jp

Sponsor
Institute	Kinki-Chuo Chest Medical Center
Institute
Department

Funding Source
Organization	Kinki-Chuo Chest Medical Center
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	大阪府立呼吸器アレルギー医療センター 摂南大学　薬学部

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 26 Day
Anticipated trial start date	2014 Year 05 Month 26 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	2014 Year 05 Month 25 Day
Last modified on	2017 Year 08 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016375