UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010150 |
|---|---|
| Receipt number | R000010559 |
| Scientific Title | Phase I Study of Intratumoral Administration of HF10, Oncolytic Herpes Simplex Virus Type 1, in Patients with Advanced Unresectable Pancreatic Cancer |
| Date of disclosure of the study information | 2013/03/04 |
| Last modified on | 2016/04/11 17:24:15 |
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Basic information
Public title
Phase I Study of Intratumoral Administration of HF10, Oncolytic Herpes Simplex Virus Type 1, in Patients with Advanced Unresectable Pancreatic Cancer
Acronym
Clinical Study using HF10 against Advanced Unresectable Pancreatic Cancer
Scientific Title
Phase I Study of Intratumoral Administration of HF10, Oncolytic Herpes Simplex Virus Type 1, in Patients with Advanced Unresectable Pancreatic Cancer
Scientific Title:Acronym
Clinical Study using HF10 against Advanced Unresectable Pancreatic Cancer
Region
| Japan |
Condition
Condition
Advanced Unresectable Pancreatic Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of HF10 in combination with conventional chemotherapy (Gemcitabine + Erlotinib).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety and tolerability
Key secondary outcomes
anti-tumor activity
Immune response
Viral replication
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Drug : HF10
Dose/cohort :
Cohort1 : 1x10(6) pfu/day
Cohort2 : 3x10(6) pfu/day
Cohort3 : 1x10(7) pfu/day
Method : 1 injection/2 weeks. Total 4 injections
in combination with Erlotinib and 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
-Non-resectable locally advanced pancreatic cancer.
-Tumor lesion accessible by EUS.
-No systemic metastasis.
(PL invasion to be included in the locally advanced cancer.)
Key exclusion criteria
Patient with:
-Ascites. pleural infusion.
-Infectious disease.
-Any other cancer.
-Brain metastasis.
-hypersensitivity to live-virus vaccine.
Pregnant or breast feeding patient.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Kasuya |
Organization
Nagoya University School of Medicine
Division name
Office of International affair
Zip code
Address
65Tusrumai-cho, Showa-ku Nagoya Japan
TEL
81-52-744-2507
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nagoya University School of Medicine
Division name
Office of International Affair
Zip code
Address
TEL
Homepage URL
kasuya@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takara Bio. Inc
Organization
Division
Category of Funding Organization
Profit organization
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 | 03 | Month | 04 | 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
| 2013 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 02 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010559
