UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007873 |
|---|---|
| Receipt number | R000009275 |
| Scientific Title | Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2015/07/28 17:01:10 |
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Basic information
Public title
Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
Acronym
Phase II Study of S-488410 to Treat NSCLC
Scientific Title
Phase II Study of Peptide Cancer Vaccine S-488410 to Treat Advanced Non-Small Cell Lung Cancer
Scientific Title:Acronym
Phase II Study of S-488410 to Treat NSCLC
Region
| Japan |
Condition
Condition
advanced non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate the clinical efficacy and safety of S-488410 for advanced non-small cell lung cancers that are refractory to standard chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of difference in overall survival after vaccination therapy between HLA-A 24:02 and non-HLA-A 24:02 patients.
Key secondary outcomes
1. Evaluation of peptides specific CTL response rate between HLA-A 24:02 and non-HLA-A 24:02 patients.
2. Evaluation of clinical efficacy of S-488410: progression free survival and objective response rate between HLA-A 24:02 and non-HLA-A 24:02 patients.
3. Evaluation of clinical efficacy of S-488410: progression free survival and overall survival between CTL response positive and negative patients.
4. Evaluation of safety and tolerability of S-488410: adverse effects (disease, grade, and incidence).
5. Identification of biomarkers for efficacy and safety of S-488410.
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 open study:
patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each)
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.Advanced NSCLC that cannot undergo curative surgery.
2.Patients that are refractory to standard chemotherapy or cannot be treated with further therapy due to severe adverse effects of chemotherapy.
3.Histologically diagnosed NSCLC.
4.Clinical efficacy can be evaluated by radiologic methods within 4 weeks prior to receiving treatment.
5.ECOG performance status 0-2 within 2 weeks prior to receiving treatment.
6.Life expectancy > 3 months.
7.Age between 20 to 79
8.Male or Female.
9.In patients or out patients.
10.Able and willing to give valid written informed consent.
Key exclusion criteria
1.Other malignancy requiring treatment
2.Concurrent treatment with anticancer drug, steroids, immunosuppressing agent, radiation, immunotherapy, hyperthermia, or surgery.
3.Active and uncontrolled infectious disease
4.Active and uncontrolled hepatic dysfunction, kidney dysfunction, cardiac disease, or lung disease (i.e. interstitial pneumonia).
5.Autoimmune disease.
6.HIV-Ab or antigen positive
7.Prior anti-cancer therapy within 4 weeks
8.Laboratory values as follows: 2000<mm3 < WBC < 15000/mm3, Platelet count < 50000/mm3, Asparate transaminase > 5 X cutoff value, Alanine transaminase > 5 X cutoff value, Total bilirubin > 3 X cutoff value, and Serum creatinine > 3X cutoff value.
9.Patients knows HLA-A type.
10.Breastfeeding and Pregnancy (woman of child bearing potential)
11.Refusal of pregnancy conception.
12.Treated with S-488401, S-488402, or S-488403.
13.Treated with other investigational drug within 3 months prior to receiving S-48810 treatment.
14.Decision of nonenrollment of the patients by principal investigator or physician-in-charge from the view point of patient's safety.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yataro Daigo MD, PhD |
Organization
Shiga University of Medical Science Hospital
Division name
Department of Medical Oncology
Zip code
Address
Seta-Tsukinowacho, Otsu, Shiga, Japan
TEL
077-548-2111
hqchiken@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yataro Daigo MD, PhD |
Organization
Shiga University of Medical Science Hospital
Division name
Department of Medical Oncology
Zip code
Address
Seta-Tsukinowacho, Otsu, Shiga, Japan
TEL
077-548-2111
Homepage URL
http://www.shiga-med.ac.jp/~hqchiken/
hqchiken@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health Labor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Showa University Hospital, Fukushima Medical University Hospital,
Tohoku University Hospital
Shionogi & Co., Ltd.
The University of Tokyo, The University of Chicago
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01592617
Org. issuing International ID_1
National Institutes of Health
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東北大学病院（宮城県）、福島県立医科大学病院（福島県）、昭和大学病院（東京都）、滋賀医科大学病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 01 | 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
| 2012 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009275
