UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009751 |
|---|---|
| Receipt number | R000011427 |
| Scientific Title | A combination phase I trial of peptide vaccines and Docetaxel/5'-DFUR in patients with advanced or recurrent gastric cancer |
| Date of disclosure of the study information | 2013/01/11 |
| Last modified on | 2013/09/09 12:52:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A combination phase I trial of peptide vaccines and Docetaxel/5'-DFUR in patients with advanced or recurrent gastric cancer
Acronym
Phase I trial of peptide vaccines in patients with advanced or recurrent gastric cancer
Scientific Title
A combination phase I trial of peptide vaccines and Docetaxel/5'-DFUR in patients with advanced or recurrent gastric cancer
Scientific Title:Acronym
Phase I trial of peptide vaccines in patients with advanced or recurrent gastric cancer
Region
| Japan |
Condition
Condition
Advanced or recurrent gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluated the safety of subcutaneous injection of HLA-A*2402 restricted epitope peptides (URLC10, KOC1, VEGFR1 and VEGFR2).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
Key secondary outcomes
Immunological effect
Objective responses
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
Dose escalation
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. Advanced or recurrent gastric cancer and resistant for standard therapy.
2. Performance status 0-2 (ECOG)
3. No need of evaluable tumor lesion
4. No major surgery, radiotherapy, or chemotherapy within 4 weeks prior to the study
5. predicted life expectancy of at least 3 months
6. Adequate baseline organ functions, defined as a leukocyte count of at least 2000, platelet count of at least 75000, and aspartate aminotransferase and alanine aminotransferase levels three times or less than the upper limit of the institutional reference range; and serum creatinine below 2.0 mg⁄ dL.
7. with HLA-A2402
8. Written informed consent.
Key exclusion criteria
Serious infectious disease or other severe complications (e.g. pulmonary fibrosis / interstitial pneumonia, uncontrollable diabetes); pregnancy or lactation, or trying to get pregnant; a history of drug allergy
Target sample size
9
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
Digestive surgery and surgical oncology
Zip code
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan
TEL
0836-22-2264
sigefumi@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigefumi Yoshino |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Digestive surgery and surgical oncology
Zip code
Address
1-1-1 Minamikokushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2264
Homepage URL
sigefumi@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine, Digestive surgery and surgical oncology
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine, 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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 11 | 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
| 2007 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | 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
| 2013 | Year | 01 | Month | 10 | Day |
Last modified on
| 2013 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011427
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
