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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009749
Receipt No. 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

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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
Email 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/
Email kokuryoh@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011413

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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