UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015415
Receipt number R000017926
Scientific Title The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear
Date of disclosure of the study information 2014/11/01
Last modified on 2018/10/06 15:54:13

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Basic information

Public title

The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear

Acronym

The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear

Scientific Title

The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear

Scientific Title:Acronym

The relationship between ocular toxicity induced by S-1 and pharmacokinetic analysis in both blood and tear

Region

Japan


Condition

Condition

Malignancy

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

We evaluate the relationship between ocular toxicity induced by S-1 and drug concentrations in both blood and tear. Furthermore, we analyze genetic polymorphisms that relate with the metabolism of S-1.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To identify the pharmacokinetic factors that is associated with ocular toxicity induced by S-1

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

S-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) Histologically or cytologically confirmed malignancy
2) Advanced cancers that S-1 are effective or gastric cancers that S-1 is indicated as adjuvant chemotherapy
3) Age is over 20 years.
4) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
5)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
Total bilirubin<2.0mg/dl
AST and ALT<2.5 times the upper limit of normal(ULN)
Creatinine<1.5mg/dl
6)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) Unstable angina or myocardial infarction within 3 months
5) Severe complication (e.g., uncontrollable diabetis mellitus, liver disease)
6) Active synchronous cancer
7) Severe psychiatric disorder
8) Pregnant or lactating women, or men and women without wanting pregnancy
9) Severe hypersensitivity to medicine
10) Patients who were judged inappropriate for the study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasutsuna Sasaki

Organization

Showa University School of Medicine

Division name

Division of Medical Oncology, Department of Medicine

Zip code


Address

1-5-8 Hatanodai, Shinagawa, Tokyo

TEL

03-3784-8000

Email

yasutsuna@med.showa-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroo Ishida

Organization

Showa University School of Medicine

Division name

Division of Medical Oncology, Department of Medicine

Zip code


Address

1-5-8 Hatanodai, Shinagawa, Tokyo

TEL

03-3784-8000

Homepage URL


Email

hishida@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Showa University School of Medicine

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


Address


Tel


Email



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

2014 Year 11 Month 01 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

Terminated

Date of protocol fixation

2014 Year 09 Month 11 Day

Date of IRB


Anticipated trial start date

2014 Year 10 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



Other

Other related information



Management information

Registered date

2014 Year 10 Month 11 Day

Last modified on

2018 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017926


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name