UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010463 |
|---|---|
| Receipt number | R000012228 |
| Scientific Title | A clinical study of an oncolytic herpes simplex type 1 (HSV-1) G47delta for patients with castration resistant prostate cancer |
| Date of disclosure of the study information | 2013/04/12 |
| Last modified on | 2016/10/12 13:55:35 |
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Basic information
Public title
A clinical study of an oncolytic herpes simplex type 1 (HSV-1) G47delta for patients with castration resistant prostate cancer
Acronym
A clinical study of an oncolytic HSV-1 G47delta for patients with castration resistant prostate cancer
Scientific Title
A clinical study of an oncolytic herpes simplex type 1 (HSV-1) G47delta for patients with castration resistant prostate cancer
Scientific Title:Acronym
A clinical study of an oncolytic HSV-1 G47delta for patients with castration resistant prostate cancer
Region
| Japan |
Condition
Condition
Castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Primary: To assess the safety of G47delta administered into the prostate in subjects with castration resistant prostate cancer.
Secondary: To assess the efficacy of G47delta by the level of PSA .
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Safety
-Spectrum and frequency of adverse events
Key secondary outcomes
Efficacy
-Change in PSA levels
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
The administration of an oncolytic HSV-1 G47delta
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
| Not applicable |
Gender
Male
Key inclusion criteria
In this single-armed phase I study, patients with prostate cancer that had not received prostatectomy and recurred after hormonal therapy are registered. Both of those with and without prior record of chemotherapy, and both of those with and without remote metastases are included.
Key exclusion criteria
-Administration of other clinical study drugs within 30 days of G47delta administration
-Known HIV seropositivity
-Current diagnosis of any medical or psychological condition that might interfere with the subject's ability to participate
-Blood test results outside protocol specified limits
-Evidence of active herpes infection
-Current diagnosis of any active malignant tumor
-Active uncontrolled infection that precludes surgery
-History of alcohol or other drug abuse
-Allergy to anti-HSV drug (acyclovir)
-Administration of any anticancer drugs within 30 days of G47delta administration
-Administration of any anti-androgen drugs within 30 days of G47delta administration
-Conditions considered inadequate for the subject to be enrolled in the study
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fukuhara |
Organization
The University of Tokyo
Division name
Urology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
03-5800-8753
hfukuhara-jua@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Fukuhara |
Organization
The University of Tokyo Hospital
Division name
Translational Research Center
Zip code
Address
7-3-1 Hongo, Bunkyo-ku Tokyo
TEL
03-5800-9072
Homepage URL
TRC@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
The University of Tokyo Hospital
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 04 | Month | 12 | 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 | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012228
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
