UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Additional analysis of gene polymolphisms in the phase II study of erlotinib in previously treated advanced non-small cell lung cancer patients with carcinomatous meningitis (UMIN000007020)
Title of the study (Brief title)	Additional analysis of gene polymorphisms in phase II study of erlotinib for carcinomatous meningitis
Region	Japan

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

Objectives
Narrative objectives1	To analyze the relationship between gene polymorphisms associated with drug metabolize or transport and clinical response or erlotinib concentrations in plasma and CSF. (UMIN000007020)
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gene polymorphisms analysis
Key secondary outcomes

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	Patients enrolled onto the phase II study of erlotinib for carcinomatous meningitis who had available blood sample after 4 weeks treatment.
Key exclusion criteria	Nothing particular
Target sample size	32

Research contact person
Name of lead principal investigator	Mitsuhiro Takenoyama
Organization	National Kyushu Cancer Center
Division name	Department of Thoracic Oncology
Address	3-1-1, Notame, Minami-ku, Fukuoka, Japan, 811-1395
TEL	092-541-3231
Email	takenoyama.m@nk-cc.go.jp

Public contact
Name of contact person	Kaname Nosaki
Organization	National Kyushu Cancer Center
Division name	Department of Thoracic Oncology
Address	3-1-1, Notame, Minami-ku, Fukuoka, Japan, 811-1395
TEL	092-541-3231
Homepage URL
Email	nosaki.k@nk-cc.go.jp

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Department of Clinical Pharmacology, National Cancer Center Research Institute Akinobu Hamada Division of Cancer Genomics, National Cancer Center Research Institute Tatsuhiro shibata
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

飯塚病院（福岡県） 北九州総合病院（福岡県） 九州大学（福岡県） 九州労災病院（福岡県） 久留米大学（福岡県） 国立病院機構大牟田病院（福岡県） 国立病院機構九州がんセンター（福岡県） 国立病院機構小倉医療センター（福岡県） 国立病院機構福岡東医療センター（福岡県） 国立病院機構福岡病院（福岡県） 浜の町病院（福岡県） 福岡青洲会病院（福岡県） 大分赤十字病院（大分県） 新別府病院（大分県） JCHO諫早総合病院（長崎県） 十善会病院（長崎県） 長崎大学（長崎県） 日本赤十字社 長崎原爆病院（長崎県） 熊本地域医療センター（熊本県） 熊本赤十字病院（熊本県） 国立病院機構熊本医療センター（熊本県） 宮崎県立宮崎病院（宮崎県） 鹿児島厚生連病院（鹿児島県） 川内市医師会立市民病院（鹿児島県） 沖縄県立南部医療センター・こども医療センター（沖縄県） 国立病院機構沖縄病院（沖縄県） 国立病院機構岩国医療センター（山口県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 04 Day
Anticipated trial start date	2013 Year 09 Month 04 Day
Last follow-up date	2016 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	To analyze retrospectively the relationship between gene polymorphisms associated with drug metabolize or transport and clinical response or erlotinib concentrations in plasma and CSF. (UMIN000007020)

Management information
Registered date	2013 Year 12 Month 19 Day
Last modified on	2017 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014395