UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The research of factor influencing gefitinib-induced toxicity in patients with non-small cell lung cancer
Title of the study (Brief title)	The research of factor influencing gefitinib-induced toxicity in patients with non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the relationship between pharmacokinetics of gefitinib and genetic polymorphisms of metabolic enzymes and transporters
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To elucidate the pharmacokinetic factors relating gefitinib-induced toxicity
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	Gefitinib
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) Histologically or cytologically confirmed non-small cell lung cancer 2) Positive for EGFR sensitive mutation 3) Unresectable advanced or recurrent disease 4) Age is over 20 years. 5) Performance status (ECOG) is 0 to 2 6) Adequate organ function, evidenced by following laboratory results within 14 days prior to starting chemotherapy Absolute neutrophil count>1,500/mm3 Platelet count>100,000/mm3 Hemoglobin>8.0g/dL AST and ALT<2.5 times the upper limit of normal(ULN) Total bilirubin<2.0mg/dL 7) Signed, written informed concent is obtained
Key exclusion criteria	1) Interstitial pneumonia, pulmonary fibrosis 2) Severe active infection 3) Serological positive for HBs-antigen or HCV-antibody 4) Previous therapy with pazopanib 5) Unstable angina or myocardial infarction within 3 months 6) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease) 7) Active synchronous cancer 8) Severe psychiatric disorder 9) Pregnant or lactating women, or men and women without wanting pregnancy 10) Severe hypersensitivity to medicine 11) Taking medicines affecting CYP3A4 within one week before starting gefitinib therapy (e.g., phenytoin, carbamazepine, rifampicin, phenobarbital, ketokonazole, macrolide) 12) Taking proton pump inhibitor or H2 blocker within one week before starting gefitinib therapy 13) Patients who were judged inappropriate for the study
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroo Ishida
Organization	Showa University School of Medicine
Division name	Division of Medical Oncology, Department of Medicine
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8000
Email	hishida@med.showa-u.ac.jp

Public contact
Name of contact person	Hiroo Ishida
Organization	Showa University School of Medicine
Division name	Division of Medical Oncology, Department of Medicine
Address	1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL	03-3784-8000
Homepage URL
Email	hishida@med.showa-u.ac.jp

Sponsor
Institute	Showa University School of Medicine
Institute
Department

Funding Source
Organization	Showa University School of Medicine
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	2017 Year 03 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 08 Day
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 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

Management information
Registered date	2017 Year 03 Month 05 Day
Last modified on	2018 Year 10 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030342