UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009053 |
|---|---|
| Receipt number | R000010626 |
| Scientific Title | Study of continuous vaccination with epitope peptides for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2016/01/05 18:24:27 |
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Basic information
Public title
Study of continuous vaccination with epitope peptides for unresectable pancreatic cancer
Acronym
Study of continuous vaccination with epitope peptides for unresectable pancreatic cancer
Scientific Title
Study of continuous vaccination with epitope peptides for unresectable pancreatic cancer
Scientific Title:Acronym
Study of continuous vaccination with epitope peptides for unresectable pancreatic cancer
Region
| Japan |
Condition
Condition
Unresectable Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to administrer the peptide vaccine continuously to advanced pancreatic cancer patients who drop out the VENUS-PC study, and to evaluate the clinical efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
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 |
Interventions/Control_1
multicenter HLA-blinded study:
patients will be vaccinated biweekly with peptide vaccine
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) Continuous administration the peptide vaccine for patients who dropped out the VENUS-PC study
(2)ECOG Performance Status must be 0,1,2 or 3
(3)Measureable region evaluable according to the RECIST(ver.1.1)
(4)Patient's condition is keeping within grade 3 hematological toxicity and within grade2 non-hematological toxicity . (CTCAE ver. 4.0)
(5)Patients must have signed the consent form.
Key exclusion criteria
(1) Active double cancer (include asynchronous double cancer with disease-free duration <=1 year) except carcinoma in situ or intramucosal cancer.
(2) Interstitial pneumonia or pulmonary fibrosis.
(3) Severe nervous disorder or mental disorder.
(4)History of myocardial infarction, severe unstable angina pectoris, CABG, congestive heart failure, cerebrovascular accident, pulmonary embolism, deep-vein thrombosis, or other severe thromboembolism within 12 months
(5) Allergy for using epitope peptides
(6)Unhealed traumatic lesion, including traumatic fracture.
(7)Pregnant females or nursing mothers who can not stop lactation after the recruitment.
(8)The subject who was determined by investigator that being not adequate to participate in the trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Oka |
Organization
Yamaguchi University Hospital
Division name
Department of Surgery II
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
geka2dm@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Suzuki |
Organization
Yamaguchi University Hospital
Division name
Department of Surgery II
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
geka2dm@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Hospital Department of Surgery II
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
| 2012 | Year | 10 | Month | 09 | 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
| 2012 | Year | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | 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
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010626
