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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003959
Receipt No. R000004767
Scientific Title Pharmacokinetics of S-1 in cancer patients with renal dysfunction.
Date of disclosure of the study information 2010/09/01
Last modified on 2017/06/04

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Basic information
Public title Pharmacokinetics of S-1 in cancer patients with renal dysfunction.
Acronym Pharmacokinetics of S-1 in cancer patients with renal dysfunction.
Scientific Title Pharmacokinetics of S-1 in cancer patients with renal dysfunction.
Scientific Title:Acronym Pharmacokinetics of S-1 in cancer patients with renal dysfunction.
Region
Japan

Condition
Condition Solid tumors
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to evaluate the pharmacokinetics of TS-1 in patients with renal dysfunction and to establish the appropriate administration of TS-1.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pharmacokinetics of FT, 5FU and CDHP on day 8 of TS-1 administration.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 eGFR is more than 80 ml/min/1.73m2
Interventions/Control_2 eGFR is 50 ml/min/1.73m2 to 80 ml/min/1.73m2
Interventions/Control_3 eGFR is 30 ml/min/1.73m2 to 50 ml/min/1.73m2
Interventions/Control_4 eGFR is less than 30 ml/min/1.73m2
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. Patients with malignant solid tumors or hematological malignancy.
2. Patients receiving TS-1 therapy as clinical practice.
3. age > 20 years.
4. Adequate hepatic and renal function.
5. Written informed consent.
Key exclusion criteria 1. Patients in hemodialysis.
2. Patients who had received TS-1 < 2 weeks prior to starting study drug.
3. Patients who had received cisplatin < 3 months prior to starting study drug.
4. Patients who had received any other chemotherapy < 3 weeks prior to starting study drug.
5. Patients who had undergone major surgery < 2 weeks prior to starting study drug.
6. Patients with malabsorption.
7. Patients with pleural effusion or ascitis requireing drainage.
8. Severe and/or uncontroled infection
9. Other concurrent severe and/or uncontroled concomitant medical conditions.
10. Patients who are currently receiving treatment with flucytosine, phenitoin or warfarin.
11. Patients judged inappropriate for the study by the physicians
Target sample size 34

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Minami
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology/Hematology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 0783825111
Email hminami@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Fujiwara
Organization Kobe University Hospital and Graduate School of Medicine
Division name Medical Oncology/Hematology
Zip code
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5820
Homepage URL
Email fu_ji_@yahoo.co.jp

Sponsor
Institute Medical Oncology/Hematology, Kobe University Hospital and Graduate School of Medicine
Institute
Department

Funding Source
Organization Medical Oncology/Hematology, Kobe University Hospital and Graduate 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 国立がん研究センター 乳腺・腫瘍内科
埼玉医科大学国際医療センター 腫瘍内科
名古屋大学医学部 呼吸器内科

Other administrative information
Date of disclosure of the study information
2010 Year 09 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 Completed
Date of protocol fixation
2010 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 09 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

Management information
Registered date
2010 Year 07 Month 28 Day
Last modified on
2017 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004767

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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