UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009749 |
|---|---|
| Receipt number | R000011413 |
| Scientific Title | Analysis of novel treatment using Nek2 siRNA for non curative pancreas cancer. |
| Date of disclosure of the study information | 2013/04/30 |
| Last modified on | 2019/01/15 20:12:21 |
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Basic information
Public title
Analysis of novel treatment using Nek2 siRNA for non curative pancreas cancer.
Acronym
Treatment using Nek2 siRNA for pancreas cancer.
Scientific Title
Analysis of novel treatment using Nek2 siRNA for non curative pancreas cancer.
Scientific Title:Acronym
Treatment using Nek2 siRNA for pancreas cancer.
Region
| Japan |
Condition
Condition
Non curative pancreas cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine, whether single intratumoral administration of Nek2 siRNA is safe and well tolerated in pancreatic cancer. This study will obtain preliminary data on the response of the cancer to this therapy. The data will be extremely valuable to help improve the approach to treat pancreatic cancer in the future.
Basic objectives2
Others
Basic objectives -Others
To assess the efficacy and pharmacokinetics of Nek2 siRNA
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Number of patients with adverse events through 28 days, as a measure of safety and tolerability using CTCAE ver4.0 criteria.
Key secondary outcomes
The overall objective clinical response rate will involve CT assessment of pancreas cancer, compared with baseline CT measurement using RECIST criteria. Overall response, progression-free survival and overall survival are assessed to determine the clinical benefit.
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 single intratumoral administration of Nek2 siRNA in pancreatic cancer
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Non curative pancreas cancer
2) Patients must be 20-84 years old
3) The long axis of target legion must be>=10 mm, and the maximum tumor volume must be<=25.2 cm3
4) Patients must have performance status of 0-2 on the ECOG (Eastern Oncology Group) scale.
5) The following criteria must be satisfied in laboratory tests
1.White blood cell count >=2,000/microL
2.Hemoglobin >=9.0 g/dL
3.Platelet count >=75,000/ microL
4.Total bilirubin <=3.0 mg/dL
5.AST<=150 IU/L
6.ALT<=150 IU/L
7. Creatinine <=1.5 mg/dL
6) Life expectancy >=3 months
7) Patients must be informed of the investigational nature of this study and must give written informed consent
Key exclusion criteria
1) Patients who have acquired, hereditary, or congenital immunodeficiency or being suspected
2) Patients have active, uncontrolled infections or being suspected
3) Patients have serious complication
4) Pregnant women or being suspected, nursing women and women of child-bearing potential, disagree to use adequate contraception
5) Patients have clinically significant and uncontrolled medical condition, considered a high risk for participation in an investigational research study
6) Patients have a medical condition contraindicated for the atelocollagen and contrast agents
7) Patients have participated in any clinical research study within the last 3 weeks.
8) Patients have received immunotherapy for cancer within the last 3 months
9) Patients have history of a second active malignancy at the time of pre-study screening
10) Patients have positive human immunodeficiency virus (HIV) or Hepatitis C antibodies (HCV) or Hepatitis B anti-core antibodies (HBV).
11) In the opinion of the principal or associate investigators, it is not in the best medical interest of the patients to enter this study, the patients will not be eligible
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Kokuryo |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan.
TEL
052-744-2222
kokuryoh@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Kokuryo |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan.
TEL
052-744-2222
Homepage URL
http://www.med.nagoya-u.ac.jp/tumor/
kokuryoh@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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 | 30 | 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
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 20 | 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 | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011413
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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