UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003959 |
|---|---|
| Receipt number | 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 | 2020/01/04 17:48:00 |
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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 | Hironobu |
| Middle name | |
| Last name | Minami |
Organization
Kobe University Hospital and Graduate School of Medicine
Division name
Medical Oncology/Hematology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
0783825111
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Fujiwara |
Organization
Kobe University Hospital and Graduate School of Medicine
Division name
Medical Oncology/Hematology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
078-382-5820
Homepage URL
fu_ji_@yahoo.co.jp
Sponsor or person
Institute
Medical Oncology/Hematology, Kobe University Hospital and Graduate School of Medicine
Institute
Department
Personal name
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
Kobe university hospital IRB
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel
078-382-5111
chiken@med.kobe-u.ac.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
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
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.14025
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/cas.14025
Number of participants that the trial has enrolled
33
Results
A total of 33 patients were enrolled and classified into 4 groups. Those in cohorts 3 and 4 treated with an adjusted dose of S1 showed a similar area under the curve for 5fluorouracil compared with cohort 2. Notably, while there was a statistically significant difference between cohort 1 and 2 (P = 0.0474) treated with an equal dose of S1, there was no significant difference observed in the toxicity profiles of the cohorts.
Results date posted
| 2020 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
S1 chemotherapy planned as part of clinical practice
Eastern Cooperative Oncology Group performance status 0 to 2
adequate hematopoietic and hepatic function.
Participant flow
A total of 33 patients were enrolled and classified into 4 groups.
Adverse events
The frequency and severity of AE were similar among the different cohorts.
Outcome measures
Pharmacokinetic parameter and toxicity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2010 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2010 | Year | 07 | Month | 28 | Day |
Last modified on
| 2020 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004767
