UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007504 |
|---|---|
| Receipt number | R000007713 |
| Scientific Title | Phase I study of peptides derived from novel cancer antigen using with Gemcitabine for advanced pancreatic cancer |
| Date of disclosure of the study information | 2012/03/17 |
| Last modified on | 2012/03/14 17:25:45 |
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Basic information
Public title
Phase I study of peptides derived from novel cancer antigen using with Gemcitabine
for advanced pancreatic cancer
Acronym
Phase I study of peptides derived from novel cancer antigen using with Gemcitabine
for advanced pancreatic cancer
Scientific Title
Phase I study of peptides derived from novel cancer antigen using with Gemcitabine
for advanced pancreatic cancer
Scientific Title:Acronym
Phase I study of peptides derived from novel cancer antigen using with Gemcitabine
for advanced pancreatic cancer
Region
| Japan |
Condition
Condition
advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of Safety and effectiveness of Combination Epitope Peptides with gemcitabine for Advanced/metastatic Pancreatic Cancer as first line therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
immune response
One Year survival rate
Two Year survival rate
Completion rate
Median Survival Time
Overall survival
Adverse Event
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
Combination Epitope Peptides with gemcitabine
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.pancreatic cancer
2.oldOne or more RECIST lesions
3.PS:0 to 2(ECOG performance status score)
4.age: over 20 years-old
5.Suspect for more than 3 months alive
6.
7.Good function of critical organs
Key exclusion criteria
1. pregnant woman
2.
3.
4.
5. Steroid or immunosuppressive therapy
6.
7.
8.Doctors opinion
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Oka |
Organization
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuaki Suzuki |
Organization
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Division name
Department of Digestive Surgery and Surgical Oncology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
Sponsor or person
Institute
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
Institute
Department
Personal name
Funding Source
Organization
YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE
Department of Digestive Surgery and Surgical Oncology
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
山口大学大学院 消化器・腫瘍外科学(YAMAGUCHI UNIVERSITY GRADUATE SCHOOL OF MEDICINE Department of Digestive Surgery and Surgical Oncology)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 17 | 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
| 2008 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | 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 | 03 | Month | 14 | Day |
Last modified on
| 2012 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007713
