UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015553
Receipt number R000018072
Scientific Title A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of sunitinib
Date of disclosure of the study information 2014/10/28
Last modified on 2014/10/28 21:05:07

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Basic information

Public title

A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of sunitinib

Acronym

PK analysis of anticancer agent for renal cancer

Scientific Title

A study to assess the efficacy, safety, pharmacokinetics and related genetic polymorphisms of sunitinib

Scientific Title:Acronym

PK analysis of anticancer agent for renal cancer

Region

Japan


Condition

Condition

renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

This study assesses the relationship between individual genetic polymorphisms and each result of PK/PD analysis based on dose, pharmacokinetics, efficacy, and safety in patients with renal cell carcinoma taking sunitinib.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

To assess PK/PD based on plasma concentration of sunitinib, as well as efficacy and safety.

Key secondary outcomes

To explore genetic polymorphisms relating to pharmacokinetics, efficacy, and safety of sunitinib.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with renal cell carcinoma
2. Patients taking sunitinib
3. Signed informed consent prior to blood sampling for this study.

Key exclusion criteria

No exclusion criteria

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuta Ohno

Organization

Gifu University Hospital

Division name

Department of Pharmacy

Zip code


Address

1-1 Yanagido, Gifu City

TEL

058-230-6000(6986)

Email

ohnoyuta@gifu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuta Ohno

Organization

Gifu University Hospital

Division name

Department of Pharmacy

Zip code


Address

1-1 Yanagido, Gifu City

TEL

058-230-6000(6986)

Homepage URL


Email

ohnoyuta@gifu-u.ac.jp


Sponsor or person

Institute

Department of Pharmacy, Gifu University Hospital

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Gifu Pharmaceutical University

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



Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 28 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

Enrolling by invitation

Date of protocol fixation

2014 Year 10 Month 21 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 28 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

prospective observational study


Management information

Registered date

2014 Year 10 Month 28 Day

Last modified on

2014 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018072


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name