UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Acronym	Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Scientific Title	Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Scientific Title:Acronym	Evaluation of intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Region	Japan

Condition
Condition	Lung cancer patients treated with chemotherapeutic drugs and aprepitant
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate intraindividual variability in hepatic CYP3A4 enzyme activity using endogenous markers in lung cancer patients treated with chemotherapeutic drugs and aprepitant
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	CYP3A endogenous markers
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	Other
Interventions/Control_1	Chemotherapeutic drugs and aprepitant to lung cancer
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)Lung cancer patients 2)Patients aged > 20 years 3)PS(ECOG) of 0 to 2 4)Patients receiving 1st line chemotherapy to non-small cell lung cancer 5)Patients receiving highly emetogenic agent 6)Fulfill all following conditions T.Bil < 1.5 mg/dL AST (GOT) < 100 IU/L ALT (GPT) < 100 IU/L Cre < 1.5 mg/dL SpO2 > = 90% 7)Written informed consent from the patients
Key exclusion criteria	1)Patients who required other chemotherapy 2)Patients who qre actively receiving inducer or inhibitor of CYP3A4 3)Patients who qre actively receiving androgen or estrogen preparation 4)Patients who qre actively receiving adrenal cortex hormone preparation without dexamethasone 5)Patients who qre actively receiving blood transfusion
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hisakazu Middle name Last name Otani
Organization	Keio University
Division name	Faculty of Pharmacy
Zip code	105-8512
Address	Shibakoen 1-5-30, Minatoku, Tokyo, Japan
TEL	03-5400-2493
Email	ohtani-hs@pha.keio.ac.jp

Public contact
Name of contact person	1st name Hideyuki Middle name Last name Hibino
Organization	Keio University
Division name	Faculty of Pharmacy
Zip code	105-8512
Address	Shibakoen 1-5-30, Minatoku, Tokyo, Japan
TEL	03-5400-2493
Homepage URL
Email	sun-light-field@z7.keio.jp

Sponsor
Institute	Keio University Faculty of Pharmacy
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	National Cancer Center Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Keio University
Address	Shibakoen 1-5-30, Minatoku, Tokyo, Japan
Tel	03-5400-2493
Email	skc-soumu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	2014-140
Org. issuing International ID_1	National Cancer Center Hospital
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 03 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 06 Day
Date of IRB	2014 Year 09 Month 24 Day
Anticipated trial start date	2018 Year 03 Month 24 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 27 Day
Last modified on	2021 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019664