UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009881
Receipt number R000011579
Scientific Title Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.
Date of disclosure of the study information 2013/01/28
Last modified on 2013/01/28 13:36:58

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Basic information

Public title

Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.

Acronym

Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.

Scientific Title

Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.

Scientific Title:Acronym

Phase I clinical trial of HLA-A*2402 restricted epitope peptide cocktail therapy with S-1 for patients with unresectable advanced metastatic pancreatic cancer.

Region

Japan


Condition

Condition

pancreatic cancer

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to examine the safety of epitope peptide from
VEGFR1, 2, KIF20A restricted to HLA-A*2402 with S-1 chemotherapy in patients with unresectable advanced pancreatic cancer

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety

Key secondary outcomes

Immunological response, Time to progression, Overall survival


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 3 epitope peptides restricted to HLA-A*2402 with S-1 chemotherapy

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Patients who have unresectable advanced pancreatic cancer
2)The presence or absence of measurable or evaluable lesions by RECIST was not taken into account.
3)Performance status (ECOG) of the patients are 0-2.
4)more than 20, less than 80 years of age.
5)Patients who can expect the survival of three months or more.
6)Patients who have undergone operation, and recovered the influence by surgery. Or two weeks or more have passed since pre-medical treatment.
7)Patients who have not been treated with S-1.
8)Adequate food intake
9)without dysfunction of multiple major organs
10)with HLA-A*2402
11)All patients gave written informed consent.

Key exclusion criteria

1)Pregnancy or lactation
2)Patients with the intention of pregnancy.
3)Patients have uncontrollable severe infectional diseases.
4)severe diarrhea.
5)Patients who are treated with steroid or immunotherapy during clinical trial.
6)Patients have uncontrollable multiple cancer.
7)Patients who have non-recovered injury.
8)Patients who have ileus and interstitial lung disiease.
9)Patients whom doctors define as inappropriate.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasuhisa Shinomura

Organization

Sapporo Medical University

Division name

1st Department of Internal Medicene

Zip code


Address

Nishi 16, Minami 1, Chuoku, Sapporo

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Masayo Hosokawa

Organization

Sapporo Medical University

Division name

1st Department of Internal Medicene

Zip code


Address


TEL

011-611-2111

Homepage URL


Email

hmasayo@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

Sapporo Medical University, 1st Department of Internal Medicine

Organization

Division

Category of Funding Organization

Self funding

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 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

No longer recruiting

Date of protocol fixation

2010 Year 06 Month 30 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 10 Day

Last follow-up date


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 28 Day

Last modified on

2013 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=R000011579


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name