UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000956
Receipt number R000001148
Scientific Title Phase I clinical trial of epitope peptides based vaccines both targeting RNF43 and VEGFR2 in patients with advanced colorectal cancer.
Date of disclosure of the study information 2007/12/23
Last modified on 2009/12/23 09:22:05

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Basic information

Public title

Phase I clinical trial of epitope peptides based vaccines both targeting RNF43 and VEGFR2 in patients with advanced colorectal cancer.

Acronym

Phase I clinical trial of epitope peptides based vaccines both targeting RNF43 and VEGFR2 in patients with advanced colorectal cancer.

Scientific Title

Phase I clinical trial of epitope peptides based vaccines both targeting RNF43 and VEGFR2 in patients with advanced colorectal cancer.

Scientific Title:Acronym

Phase I clinical trial of epitope peptides based vaccines both targeting RNF43 and VEGFR2 in patients with advanced colorectal cancer.

Region

Japan


Condition

Condition

unresectable colorectal cancer

Classification by specialty

Medicine in general Surgery in general

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

safety

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety

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 Vaccine

Interventions/Control_1

Vaccination using epitope peptide

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Performance status 0-2
HLA-A24
No responce to CPT-11,5-FU, LV, Oxialiplatin)
etc

Key exclusion criteria

pregnancy
uncontroled infection
uncontroled cerebral metastasis
etc.

Target sample size

6


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kanamoto Akira

Organization

Institute of Medical Science
The University of Tokyo

Division name

surgery and bioengineering

Zip code


Address

4-6-1,shirokanedai, minato-ku, tokyo, japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Institute of Medical Science

Division name

surgery and bioengineering

Zip code


Address


TEL


Homepage URL


Email

kanamoto@ims.u-tokyo.ac.jp


Sponsor or person

Institute

Institute of Medical Science
The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Government

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

2007 Year 12 Month 23 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

Completed

Date of protocol fixation

2007 Year 12 Month 12 Day

Date of IRB


Anticipated trial start date

2007 Year 12 Month 01 Day

Last follow-up date

2009 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2007 Year 12 Month 23 Day

Last modified on

2009 Year 12 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001148


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name