Unique ID issued by UMIN | UMIN000012720 |
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Receipt number | R000013947 |
Scientific Title | Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients |
Date of disclosure of the study information | 2014/01/01 |
Last modified on | 2021/06/08 15:28:02 |
Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients
GENESECT study
Pharmacogenomics study of gemcitabine on the safety and efficacy in metastatic pancreatic cancer patients
GENESECT study
Japan |
Metastatic Pancreatic Cancer
Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Malignancy
YES
To investigate the association with genetic polymorphisms and CA19-9 response and adverse reactions of gemcitabine in metastatic pancreatic cancer patients.
Safety,Efficacy
CA19-9 response: Reduction of >50% from the pretreatment level at 8 weeks after first gemcitabine administration.
1) Time to CA19-9 response during gemcitabine treatment
2) The proportion of CA19-9 decrease in the pre-treatment level and nadir level.
3) Overall survival
4) Adverse drug reactions
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients who confirmed the diagnosis of pancreatic cancer
2) Metastatic pancreatic cancer
3) 20 years of age or older
4) ECOG PS 0-2
5) No prior chemotherapy or radiotherapy before enrollment
6) Patients who scheduled for the standard dose of gemcitabine monotherapy or combination therapy with nab-Paclitaxel and gemcitabine as first line treatment
7)Patients with a serum CA19-9 level of >= 100 U/mL within 4 weeks prior to registration
8) Adequate organ function obtained within 4 weeks prior to registration.
Laboratory values must be as follows;
Absolute neutrophil count >= 1,500 /mm3,
Hemoglobin >= 9.0 g/dL
Platelet count >= 100,000 /mm3
AST <= 150 IU/L
ALT <= 150 IU/L
Total bilirubin less than or equal to 2.0 mg/dL(to be permitted <=3.0 mg/dL in patients treated by biliary drainage for obstructive jaundice)
serum creatinine <= 1.5 mg/dL
9)Informed consent by the document
1) Known prior severe hypersensitivity to clinical trial medicines
2)Patients with an active concomitantly existed
3)Patients with an active concomitant infection
4)Patients with pulmonary fibrosis or interstitial pneumonia
5)Patient with severe uncontrollable diabetes mellitus
6)Pregnant, breastfeeding or expecting woman
7)Other clinical difficulties in this study
250
1st name | Kunihiko |
Middle name | |
Last name | ITOH |
Univercity of Shizuoka
School of Pharmaceutical Science
422-8526
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
054-264-5674
ithok@u-shizuoka-ken.ac.jp
1st name | Daiki |
Middle name | |
Last name | TSUJI |
Univercity of Shizuoka
School of Pharmaceutical Science
422-8526
52-1, Yada, Suruga-ku, Shizuoka, 422-8526, Japan
054-264-5674
d-tsuji@u-shizuoka-ken.ac.jp
Department of Clinical Pharmacology and Genitics, School of Pharmaceutical Science, Univercity of Shizuoka
None
Self funding
The Cancer Institute Hospital Of JFCR
3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
03-3520-0111
tiken@ml.jfcr.or.jp
NO
2014 | Year | 01 | Month | 01 | Day |
Unpublished
No longer recruiting
2013 | Year | 11 | Month | 05 | Day |
2014 | Year | 03 | Month | 06 | Day |
2014 | Year | 07 | Month | 01 | Day |
2020 | Year | 12 | Month | 31 | Day |
Blood samples are collected from metastatic pancreatic cancer patients before gemcitabine administration. Relationship between efficacy of gemcitabine and genitic polymorphisms are assessed.
2013 | Year | 12 | Month | 28 | Day |
2021 | Year | 06 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013947
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