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

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 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


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

Value
https://center6.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