UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005095 |
|---|---|
| Receipt number | 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 14:59:31 |
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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
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
takeo@kanazawa-med.ac.jp
Sponsor or person
Institute
1)Multidisciplinary Cancer Center,Kanazawa Medical University Hospital
2)Department of Surgical Oncology, Kanazawa Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006032
