UMIN-CTR Clinical Trial

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
Email	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
Email	t.inaishi@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022235