UMIN-CTR Clinical Trial

Basic information
Public title	Study of the relationship between antiemetic effect of aprepitrant and genetic polymorphism of ABC transporter
Acronym	Study of the relationship between antiemetic effect of aprepitrant and genetic polymorphism of ABC transporter
Scientific Title	Study of the relationship between antiemetic effect of aprepitrant and genetic polymorphism of ABC transporter
Scientific Title:Acronym	Study of the relationship between antiemetic effect of aprepitrant and genetic polymorphism of ABC transporter
Region	Japan

Condition
Condition	Malignant tumor (lung cancer, gastric cancer, etc)
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To investigate the association between the efficacy of aprepitant and genetic polymorphisms in prevention of cisplatin induced emesis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Proportion of complete response (defined as no emesis and no rescue treatment). [Time Frame: overall; 0-120hr(during and post chemotherapy), acute phase;0-24hr, delayed phase 24-120hr]
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) Malignant tumor patients except for hematopoietic malignancy 2) Patients who receive the chemotherapy involving cisplatin (>= 50 mg/m2) 3) 20 years-old over at the time of giving informed consent 4) ECOG PS 0-2 5) Adequate organ function obtained within 2 weeks prior to registration. Laboratory values must be as follows; T-Bill <= 1.5 mg/dL AST <= 100 IU/L ALT <= 100 IU/L 6)Informed consent by the document
Key exclusion criteria	1) Known prior severe hypersensitivity to platinum-containing drug, 5HT3 receptor antagonist, corticosteroids and aprepitant 2) Patients who do not have enough whole body state to the antineoplastic agents treatment 3) Pregnant, breastfeeding or expecting woman 4) Patient with severe uncontrollable diabetes mellitus 5) Known symptomatic brain metastasis 6) Patients who take a medicine regularly such as corticosteroids, dopamine D2-receptor antagonist, phenothiazine tranquilizers, antihistamine drugs and benzodiazepine etc 7) Other clinical difficulties in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Daiki Middle name Last name Tsuji
Organization	Univercity of Shizuoka
Division name	School of Pharmaceutical Science
Zip code	422-8526
Address	52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL	054-264-5674
Email	d-tsuji@u-shizuoka-ken.ac.jp

Public contact
Name of contact person	1st name Daiki Middle name Last name Tsuji
Organization	Univercity of Shizuoka
Division name	School of Pharmaceutical Science
Zip code	422-8526
Address	52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
TEL	054-264-5674
Homepage URL
Email	d-tsuji@u-shizuoka-ken.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology and Genitics, School of Pharmaceutical Science, Univercity of Shizuoka
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	SEIREI Hamamatsu General Hospital
Address	2-12-12 Naka-ku, Sumiyoshi, Hamamatsu-city, Shizuoka, Japan
Tel	053-474-2222
Email	hmchiken@sis.seirei.or.jp

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	2011 Year 02 Month 10 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	Open public recruiting
Date of protocol fixation	2010 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Blood samples are collected from cancer patients who received cisplatin-containing regimen. Relationship between genitic polymorphisms and antiemetic effect of aprepitant are assessed.

Management information
Registered date	2011 Year 01 Month 20 Day
Last modified on	2020 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005837