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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009085
Receipt No. R000010627
Scientific Title Continuous administration trial of Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer
Date of disclosure of the study information 2012/11/01
Last modified on 2015/11/20

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Basic information
Public title Continuous administration trial of Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer
Acronym Continuous administration trial of Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer
Scientific Title Continuous administration trial of Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer
Scientific Title:Acronym Continuous administration trial of Phase2 Study of OCV-101 in Combination With Gemcitabine in Patients With Unresectable Advanced Pancreatic Cancer and Recurrent Pancreatic Cancer
Region
Japan

Condition
Condition Unresectable Advanced and Recurrent Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To provide the subject with OCV-101 and Gemcitabine.
To evaluate the efficacy and safety of OCV-101 in combination with Gemcitabine.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Overall Survival (OS)
Key secondary outcomes

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 OCV-101 1mL will be administered by subcutaneous injection on days, 1,8,15 and 22 of each 28-day treatment cycles.
Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on days, 1, 8 and 15.
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 1) Patients who are under trial treatment in SE01.
2) Patients who wish to continue trial treatment. And there is no obvious disease progression, also it is judged that there is clinical benefit by continuing trial treatment.
3) ECOG Performance Status must be 0 to 2.
4) Patient must have signed the consent form.
Key exclusion criteria
Target sample size 2

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Masami Sakai
Organization OncoTherapy Science, Inc.
Division name Clinical Development Dept., Research & Development Division
Zip code
Address Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization OncoTherapy Science, Inc.
Division name Clinical Development Dept., Research & Development Division
Zip code
Address Kanagawa Science Park R&D D11F, 3-2-1, Sakado, Takatsu-ku, Kawasaki City, Kanagawa Pref Japan
TEL 044-820-8259
Homepage URL
Email

Sponsor
Institute OncoTherapy Science, Inc.
Institute
Department

Funding Source
Organization Otsuka Pharmaceutical Co.,LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2012 Year 11 Month 01 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
2012 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2014 Year 08 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
2012 Year 10 Month 11 Day
Last modified on
2015 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010627

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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