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
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
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
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
