Unique ID issued by UMIN | UMIN000022129 |
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Receipt number | R000025489 |
Scientific Title | The clinical trials for safety and usefulness of chronic hepatitis therapeutics,agent 3-oxygelmillpropionic acid polymer for the advanced and recurrent colorectal cancer of having the existing chemotherapeutic refractory or intolerance.(Phase 1 test) |
Date of disclosure of the study information | 2016/04/28 |
Last modified on | 2021/11/04 15:51:41 |
The clinical trials for safety and usefulness of chronic hepatitis therapeutics,agent 3-oxygelmillpropionic acid polymer for the advanced and recurrent colorectal cancer of having the existing chemotherapeutic refractory or intolerance.(Phase 1 test)
Propagermanium test
The clinical trials for safety and usefulness of chronic hepatitis therapeutics,agent 3-oxygelmillpropionic acid polymer for the advanced and recurrent colorectal cancer of having the existing chemotherapeutic refractory or intolerance.(Phase 1 test)
Propagermanium test
Japan |
The advanced and recurrent colorectal cancer of having the refractory or intolerance of existing chemotherapy
Gastrointestinal surgery |
Malignancy
YES
In the advanced and recurrent colorectal cancer, we examine the safety and anti-tumor effect of 3-oxygelmillpropionic acid polymer (a trade name: Seroshion) .
Safety,Efficacy
Safety
Efficacy and pharmacokinetics
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
1
Treatment
Medicine |
The dose of Seroshion is 1 capsule (10mg) /time after each meal (3 times/day,30mg/day). The administration period is six months.
20 | years-old | <= |
Not applicable |
Male and Female
(1)The patients who obtained the written consent before performing the various procedures for the test. Patients who can understand and are willing to sign the contents of the consent document.(2) The case who was diagnosed histologically colorectal cancer and was decided to be unresectable by the distant metastases or locally advanced. (3)The patients who have intolerance of standard chemical treatment and were exacerbated within 3 months from the last administration,fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and anti-EGFR antibody drugs (cetuximab or panitumumab).(4)The age is over 20 years old.(5)PS (ECOG) is 0 or 1. (6)3 months or more survivor.(7)The patients can eat orally.(8)Within 14 days before,major organ function is held by clinical examination.(a)WBC is above 3,000 / mm3 and below 12,000/mm3,b)Neu is above 1,500/mm3,c)Plt is above 100,000/mm3, d)Hb is above 8.0g / dL,e)T-bil is below 2.0mg/dL,f) AST (GOT) is below 100IU / L,g) ALT (GPT)is below 100IU/L,h) Cr is below 1.2mg/dL(8)The patients who consent by the document.
(1)Patients with active double cancer.(2)Patients with serious drug hypersensitivity or with a history of drug allergy.(3)Patients with serious complications.(4)Patients with jaundice,cirrhosis or with suspected cirrhosis of the liver.(5)There is a history of chronic hepatitis B, and in the present study drug has already been ingested.(6)Patients with active infection.(7)Women who have a possibility of or in the pregnancy,who hope to become pregnant,or who are breast-feeding. Men who wish to become pregnant partner.(8)Patients with severe mental disorder.(9Other patients whom the physician decided to be unsuitable for safely carrying out the present study.
5
1st name | Mamoru |
Middle name | |
Last name | Uemura |
Osaka University,Graduate School of Medicine
Gastroenterological Surgery
565-0871
2-2,Yamadaoka,Suita City, Osaka
0668793251
muemura@gesurg.med.osaka-u.ac.jp
1st name | Mamoru |
Middle name | |
Last name | Uemura |
Osaka University,Graduate School of Medicine
Gastroenterological Surgery
565-0871
2-2,Yamadaoka,Suita City, Osaka
0668793251
muemura@gesurg.med.osaka-u.ac.jp
Osaka University Hospital
Self funding
Self funding
Osaka University Clinical Research Review Committee
2-2,Yamadaoka,Suita City, Osaka
0662108296
kida@dmi.med.osaka-u.ac.jp
NO
2016 | Year | 04 | Month | 28 | Day |
Unpublished
Completed
2016 | Year | 05 | Month | 16 | Day |
2015 | Year | 12 | Month | 01 | Day |
2016 | Year | 05 | Month | 16 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2020 | Year | 03 | Month | 31 | Day |
2016 | Year | 04 | Month | 28 | Day |
2021 | Year | 11 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025489
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