Unique ID issued by UMIN | UMIN000002950 |
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Receipt number | 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 15:32:38 |
Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients
Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
Phase I study using pulverized curcumin for pancreatic/biliary tract cancer patients
Japan |
Advanced pancreatic/biliary tract cancer patients who get resistant to gemcitabine-based chemotherapy
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Malignancy
NO
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
Safety
Exploratory
Explanatory
Phase I
Phase I; To find a recommended dose of pulverized curcumin
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
pulverized curcumin
20 | years-old | <= |
Not applicable |
Male and Female
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
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
12
1st name | |
Middle name | |
Last name | Masashi Kanai |
Kyoto University Hospital
Outpatient Oncology Unit
54 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
1st name | |
Middle name | |
Last name | Masashi Kanai |
Kyoto University Hospital
Outpatient Oncology Unit
075-751-4770
Kyoto University Hospital
Japan Research Foundation For Clinical Pharmacology
Non profit foundation
NO
2010 | Year | 12 | Month | 01 | Day |
Published
Completed
2009 | Year | 12 | Month | 28 | Day |
2010 | Year | 01 | Month | 01 | Day |
2009 | Year | 12 | Month | 28 | Day |
2013 | Year | 08 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003588
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