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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010150
Receipt No. 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

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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
Email

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
Email kasuya@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010559

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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