UMIN-CTR Clinical Trial

Basic information
Public 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)
Acronym	Propagermanium test
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)
Scientific Title:Acronym	Propagermanium test
Region	Japan

Condition
Condition	The advanced and recurrent colorectal cancer of having the refractory or intolerance of existing chemotherapy
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	In the advanced and recurrent colorectal cancer, we examine the safety and anti-tumor effect of 3-oxygelmillpropionic acid polymer (a trade name: Seroshion) .
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety
Key secondary outcomes	Efficacy and pharmacokinetics

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	The dose of Seroshion is 1 capsule (10mg) /time after each meal (3 times/day,30mg/day). The administration period is six months.
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)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.
Key exclusion criteria	(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.
Target sample size	5

Research contact person
Name of lead principal investigator	1st name Mamoru Middle name Last name Uemura
Organization	Osaka University,Graduate School of Medicine
Division name	Gastroenterological Surgery
Zip code	565-0871
Address	2-2,Yamadaoka,Suita City, Osaka
TEL	0668793251
Email	muemura@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Mamoru Middle name Last name Uemura
Organization	Osaka University,Graduate School of Medicine
Division name	Gastroenterological Surgery
Zip code	565-0871
Address	2-2,Yamadaoka,Suita City, Osaka
TEL	0668793251
Homepage URL
Email	muemura@gesurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2,Yamadaoka,Suita City, Osaka
Tel	0662108296
Email	kida@dmi.med.osaka-u.ac.jp

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	2016 Year 04 Month 28 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	Completed
Date of protocol fixation	2016 Year 05 Month 16 Day
Date of IRB	2015 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 16 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 04 Month 28 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025489