UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009833
Receipt number R000011011
Scientific Title The evaluation of theraputic effects for advanced renal cell carcinoma patients using axitinib; dose intensity, gene polymorphism and micro vascular density
Date of disclosure of the study information 2013/01/22
Last modified on 2021/01/28 16:37:23

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Basic information

Public title

The evaluation of theraputic effects for advanced renal cell carcinoma
patients using axitinib; dose intensity, gene polymorphism and micro vascular density

Acronym

The evaluation of theraputic effects for advanced renal cell carcinoma
patients using axitinib

Scientific Title

The evaluation of theraputic effects for advanced renal cell carcinoma
patients using axitinib; dose intensity, gene polymorphism and micro vascular density

Scientific Title:Acronym

The evaluation of theraputic effects for advanced renal cell carcinoma
patients using axitinib

Region

Japan


Condition

Condition

Advanced Renal Cell Carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To measurment dose intensity using axitinib, gene polymorphism and micro vascular density with axitinib

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

dose intensity, gene polymorphism and micro vascular density with axitinib

Key secondary outcomes

clinical response using RECIST ver4.0,
adverse event using CTCAE ver4.0, mapping in pathology


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

Gene

Interventions/Control_1

measrument dose intensity using axitinib and measurment gene polymorphism

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) over 20yrs
2) advanced RCC patients (cTxN1-2M0-1)
need general treatment
3) ECOG PS0,1
4) suitable organ function
liver,kidney, hematolgy
5) noemal herat function LVEF >70%
6) Pts had target lesions difiend vy RECIST ver1.1
7) Pts had informed and concent

Key exclusion criteria

unfit eligible criteria
1)ptotein uria 2+<
2)Pts had another cancers
3)Pts had myocardial infarction, pulumonary embolisim, brain infarction, heart failure, TIA, CABG within 6 months
4) pregnant

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoto Sassa

Organization

Nagoya University

Division name

Urology

Zip code


Address

Showa-ku Tsurumai-Cho 65, Nagoya , Aichi

TEL

052-744-2985

Email

sassa@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Koyama

Organization

Nagoya University

Division name

soumu-ka

Zip code


Address

Showa-ku Tsurumai-Cho 65, Nagoya , Aichi

TEL

052-744-1901

Homepage URL


Email

ethics@med.nagoya-u.ac.jp


Sponsor or person

Institute

The department of urology, Graduate School of Medicine, Nagoya University

Institute

Department

Personal name



Funding Source

Organization

The department of urology, Graduate School of Medicine, Nagoya University

Organization

Division

Category of Funding Organization

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 22 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

Open public recruiting

Date of protocol fixation

2013 Year 01 Month 22 Day

Date of IRB

2013 Year 01 Month 22 Day

Anticipated trial start date

2013 Year 01 Month 23 Day

Last follow-up date

2021 Year 01 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

2013 Year 01 Month 22 Day

Last modified on

2021 Year 01 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011011


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name