UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacokinetic study of gefitinib in patients with non-small cell lung cancer
Title of the study (Brief title)	Pharmacokinetic study of gefitinib in patients with non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To examine the difference in gefitinib exposure by treatment schedules in non-small cell lung cancer
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference in gefitinib exposure by treatment schedules in non-small cell lung cancer
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	1) Pathologically confirmation of non small cell lung cancer 2) EGFR gene mutation has been examined 3) Administration of gefitinib is planned or ongoing 4) Aged 20 or more 5) Expected survival over 12 weeks 6) Adequate organ functions 7) Written informed consent
Key exclusion criteria	Patients with interstitial pneumonitis identified by chest X-ray
Target sample size	30

Research contact person
Name of lead principal investigator	Toshiaki Takahashi
Organization	Shizuoka cancer center
Division name	Devision of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL	(+81)055-989-5222
Email	t.takahashi@scchr.jp

Public contact
Name of contact person	Takahisa Kawamura/ Hirotsugu Kenmotsu
Organization	Shizuoka cancer center
Division name	Division of Thoracic Oncology
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL	(+81)055-989-5222
Homepage URL
Email	ta.kawamura@scchr.jp

Sponsor
Institute	Shizuoka cancer center
Institute
Department

Funding Source
Organization	Shizuoka cancer center
Organization
Division
Category of Funding Organization	Other
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 10 Month 19 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 08 Month 14 Day
Anticipated trial start date	2015 Year 10 Month 19 Day
Last follow-up date	2018 Year 12 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	Prospective observational study about the difference in gefitinib exposure by treatment schedules in non-small cell lung cancer. Since October 2015, thirty patients with inclusion criteria will be enrolled. Evaluation of factors influencing gefitinib pharmacokinetics.

Management information
Registered date	2015 Year 10 Month 19 Day
Last modified on	2017 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022453