UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chemotherapy for advanced pancreatic cancer with combined usage of gemcitabine and GSK3beta-inhibiting medicines
Title of the study (Brief title)	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	Takeo Shimasaki
Organization	Kanazawa Medical University Hospital
Division name	Gastroenterology
Address	Uchinada, Ishikawa 9200293
TEL	076-286-2211
Email	takeo@kanazawa-med.ac.jp

Public contact
Name of contact person	Takeo Shimasaki
Organization	Kanazawa Medical University Hospital
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 01 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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