UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022129
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

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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 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 or person

Institute

Osaka University Hospital

Institute

Department

Personal name



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

Value
https://center6.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