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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002950
Receipt No. R000003588
Scientific Title Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
Date of disclosure of the study information 2010/12/01
Last modified on 2013/08/03

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Basic information
Public title Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
Acronym Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients
Scientific Title Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
Scientific Title:Acronym Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients
Region
Japan

Condition
Condition Advanced pancreatic/biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
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 To evaluate the safety and efficacy of complementary therapy using pulverized curcumin for pancreatic or biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Phase I; To find a recommended dose of pulverized curcumin
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 pulverized curcumin
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who have histologically or radiologically comfirmed pancreatic/biliary tract cancer
2. Patients who get resistant to gemcitabine based chemotherapy
3. Age >/=20
4. ECOG performance status </=2
5. Adequate oral intake
6. Adequate organ and bone marrow function
7. Provided written informed consent
Key exclusion criteria 1. Patients with active interstitial pneumonia or pulmonary fibrosis
2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
3. Patients with severe infection
4. Patients with severe drug allergy
5. Patients with other serious comorbid diseases
6. Pregnant women or patients who wish pregnanct
7. Patients with mental diseases
8. Patients who are judged inappropriate for the entry into the study by the investigator
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kanai
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address 54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Kanai
Organization Kyoto University Hospital
Division name Outpatient Oncology Unit
Zip code
Address
TEL 075-751-4770
Homepage URL
Email

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Japan Research Foundation For Clinical Pharmacology
Organization
Division
Category of Funding Organization Non profit foundation
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
2010 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 01 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
2009 Year 12 Month 28 Day
Last modified on
2013 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003588

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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