UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020306
Receipt No. R000023420
Scientific Title A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.
Date of disclosure of the study information 2015/12/24
Last modified on 2017/11/10

* 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 phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.
Acronym Metoformin addition combination phase II clinical trial for the personalized peptide vaccine resistant patients.
Scientific Title A phase II clinical trial of the metformin extra combination for the personalized peptide vaccine resistance patients who is not complicatrd with diabetes.
Scientific Title:Acronym Metoformin addition combination phase II clinical trial for the personalized peptide vaccine resistant patients.
Region
Japan

Condition
Condition The patients whom a symptom aggravates without being complicated with diabetes of various personalized peptide vaccine phase II trial entries.
Classification by specialty
Medicine in general Gastroenterology Pneumology
Hematology and clinical oncology Nephrology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery
Breast surgery Obsterics and gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Oral surgery Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of study is examination having immunoactive increase or not when used metformin together in personalized peptide vaccination.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Assesment of immunoresponses by mesuremant of peptide specific IgGs before and after peptide vaccination with metformin.
Key secondary outcomes Safety assessments
Clinical response(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 For the patients who were enrolled personalized peptide vaccination and judged as exacerbation at the end of 1st course of clincal trial, add metoformin 500mg/Day on peptide vaccination.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects must satisfy the following conditions.
1)Patients who is not complicated with diabetes and HbA1c level is less than 6.5%
2)Patient who were enrolled personalized peptide vaccination and judged as exacerbation at the end of 1st course of clincal trial.
3)Patients must be a at a score level 0-2 of ECOG performance status.
4)Patients must have IgGs reactive to at least 2 of the candidate peptides restricted to the patient's HLA types.
5)Patients must be excepted to survive more than 3 months.
6)Patients must satisfy the followings:
WBC >and= 2500/mm3
Lymphocyte >and= 900/mm3
Hb >and= 8.0g/dL
Platelet >and= 50000/mm3
Serum Creatinine <and= 2.0mg/dL
Total Bilirubin <and= 2.5mg/dL
7)Patients must be more 18 years-old.
8)Written informed consent must be obtained from patients.
9)patients must be positive for HLA-class I A(-2,-24,-26,-3,-11,-31 or -33).

Key exclusion criteria The following patients must be excluded.
1)Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation, et al.)
2)Patients with the past history of severe allergic reactions.
3)(Female)Pregnant or nursing patients.
(Male)Patients who do not accept contraception from the 1st vaccination to 70 days after last vaccination.
4)Patients who are judjed inappropriate for entry to this clinical trial by doctors.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeru Yutani
Organization Kurume University
Division name Cancer Vaccine Center
Zip code
Address 155-1 Kokubu-machi Kurume-city Fukuoka pref. Japan, 839-0863
TEL 0942-27-5210
Email yutani@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Yutani
Organization Kurume University
Division name Cancer Vaccine Center
Zip code
Address 155-1 Kokubu-machi Kurume-city Fukuoka pref. Japan, 839-0863
TEL 0942-27-5210
Homepage URL http://www.med.kurume-u.ac.jp/med/cvc/
Email yutani@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization None
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 久留米大学がんワクチンセンター(福岡県)Kurume University Cancer Vaccine Center(Fukuoka)
内藤病院(福岡県)Naitoh Hosp.(Fukuoka)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 24 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 Terminated
Date of protocol fixation
2015 Year 11 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 24 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 12 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 22 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023420

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.