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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022129
Receipt No. 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 2016/07/12

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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
Middle name
Last name Tsunekazu Mizushima
Organization Osaka University,Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2,Yamadaoka,Suita City, Osaka
TEL 0668793251
Email tmizushima@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsunekazu Mizushima
Organization Osaka University,Graduate School of Medicine
Division name Gastroenterological Surgery
Zip code
Address 2-2,Yamadaoka,Suita City, Osaka
TEL 0668793251
Homepage URL
Email tmizushima@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
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
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 Open public recruiting
Date of protocol fixation
2016 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 16 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
2016 Year 04 Month 28 Day
Last modified on
2016 Year 07 Month 12 Day


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

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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