UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019244 |
|---|---|
| Receipt number | R000022235 |
| Scientific Title | A study of pharmacokinetic analysis of capecitabine and cytidine deaminase activity |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2021/04/09 11:29:08 |
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Basic information
Public title
A study of pharmacokinetic analysis of capecitabine and cytidine deaminase activity
Acronym
A study of pharmacokinetic analysis of capecitabine and cytidine deaminase activity
Scientific Title
A study of pharmacokinetic analysis of capecitabine and cytidine deaminase activity
Scientific Title:Acronym
A study of pharmacokinetic analysis of capecitabine and cytidine deaminase activity
Region
| Japan |
Condition
Condition
Breast and colorectal cancer
Classification by specialty
| Gastrointestinal surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the correlation pharmacokinetic analysis of capecitabine, its metabolites and cytidine deaminase activity.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation AUC of 5-DFUR/AUC of 5-DFCR ratio and cytidine deaminase activity.
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
Blood samples(10 points) are collected after the first administration of capecitabine for pharmacokinetic analysis and cytidine deaminase activity measurement.
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 proven breast or colorectal cancer patients
2)Age>= 20 years
3)Planned to receive capecitabine
4)PS(ECOG):0-2
5)Adequate organ function
white blood-cell count>= 3,000/uL
hemoglobin concentration >= 9.0g/dL
platelet count>= 100,000/uL
6)Life expectancy more than 3 months
7)Written informed consent
Key exclusion criteria
1)Patients that administration of capacitabine is contraindicated
2)Patients with administration of warfarin
3)Patients with active infections
4)Patients who judged by investigator to be inappropriate for study participation for serious psychiatric condition
5)Patients who judged by investigator to be inappropriate for study participation for any reason
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ando |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
TEL
052-744-1903
yando@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Inaishi |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
TEL
052-744-1903
Homepage URL
t.inaishi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
名古屋大学医学部附属病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2015 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2015 | Year | 10 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022235
