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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005095
Receipt No. R000006032
Scientific Title Chemotherapy for advanced pancreatic cancer with combined usage of gemcitabine and GSK3beta-inhibiting medicines
Date of disclosure of the study information 2011/02/18
Last modified on 2018/02/21

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Basic information
Public title Chemotherapy for advanced pancreatic cancer with combined
usage of gemcitabine and GSK3beta-inhibiting medicines
Acronym GSK COCKTAIL
Scientific Title Chemotherapy for advanced pancreatic cancer with combined
usage of gemcitabine and GSK3beta-inhibiting medicines
Scientific Title:Acronym GSK COCKTAIL
Region
Japan

Condition
Condition advanced pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safety of combined usage of gemcitabine and
GSK3beta-inhibiting medicines for advanced pancreatic cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes safety
Key secondary outcomes Response rate

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 From Jan/21/2011 to Feb/28/2015
medicine:GSK cocktail is taken every day together with standard gemcitabine drip infusion therapy (once a week for 3 weeks and one week rest)
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
15 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) The age is between 15 and 90 years old.
2) Diagnosis of pancreatic cancer is confirmed by imaging studies, and its clinical stage is advanced.
3) There is no allergy to the drugs used.
4) An appropriate organ function is preserved.
5) There is no condition in which oral administration of drugs is hindered.
6) Informed consent as a document is obtained from the patient or his/her family before enrollment.
Key exclusion criteria 1) A patient who has a past history of hypersensitivity to the medicines used.
2) A pregnant woman, a woman of possible pregnancy, or a lactating woman
3) Miscellaneous patients who are judged inadequate for enrollment by an
attending physician
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeo Shimasaki
Organization Kanazawa Medical University Hospital
Division name Gastroenterology
Zip code
Address Uchinada, Ishikawa 9200293
TEL 076-286-2211
Email takeo@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeo Shimasaki
Organization Kanazawa Medical University Hospital
Division name Gastroenterology
Zip code
Address Daigaku 1-1 Uchinada Ishikawa pref. Japan
TEL 076-286-2211
Homepage URL
Email takeo@kanazawa-med.ac.jp

Sponsor
Institute 1)Multidisciplinary Cancer Center,Kanazawa Medical University Hospital
2)Department of Surgical Oncology, Kanazawa Medical University Hospital
Institute
Department

Funding Source
Organization Kanazawa Medical University Hospital
Multidisciplinary Cancer Center
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor 1)Division of Translational and Clinical Oncology, Cancer Research Institute,Kanazawa University
2)Department of Neurosurgery, Kanazawa University Hospital
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 金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 18 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 Open public recruiting
Date of protocol fixation
2011 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 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
2011 Year 02 Month 16 Day
Last modified on
2018 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006032

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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