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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022235


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name