UMIN-CTR Clinical Trial

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

Malignant tumor (lung cancer, gastric cancer, etc)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

02

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2011

Year

01

Month

20

Day

Last modified on

2020

Year

07

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005837