UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027441 |
|---|---|
| Receipt number | R000031431 |
| Scientific Title | The clinical trial for safety and efficacy of chronic hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1) |
| Date of disclosure of the study information | 2017/05/23 |
| Last modified on | 2017/05/22 16:33:44 |
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Basic information
Public title
The clinical trial for safety and efficacy of chronic hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Acronym
Hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Scientific Title
The clinical trial for safety and efficacy of chronic hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Scientific Title:Acronym
Hepatitis therapeutics agent, 3-oxygelmillpropionic acid polymer for pancreatic cancer (Phase 1)
Region
| Japan |
Condition
Condition
Resectable pancreatic cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In pancreatic cancer, we examine the safety and anti-tumor effect of 3-oxygelmillpropionic acid polymer (a trade name: Seroshion) .
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety
Key secondary outcomes
efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
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 case who was diagnosed histologically pancreatic cancer (2)The case who underwent R0 resection for pancreatic cancer.(3)The age is over 20 years old.(4)PS (ECOG) is 0 or 1. (5)Within 14 days before,major organ function is held by clinical examination.1)WBC is above 3,000 / mm3 and below 12,000/mm3. 2)Plt is above 100,000/mm3, 3)Hb is above 8.0g / dL, 4)AST (GOT) is below 100IU / L, and ALT (GPT)is below 100IU/L. 5)T-bil is below 2.0mg/dL. 6)Cr is below 1.2mg/dL 7)Ccr is above 50mL/min. (6)The patients can eat orally. (7)The patients who can start treatment within 4 to 12 weeks after surgery. (8)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.
Key exclusion criteria
(1)Patients who could not resected curatively.(2)Patients with active double cancer. (3)Patients with serious drug hypersensitivity or with a history of drug allergy.(4)Patients with serious complications.(5)Patients with jaundice,cirrhosis or with suspected cirrhosis of the liver.(6)There is a history of chronic hepatitis B, and in the present study drug has already been ingested.(7)Patients with active infection.(8)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.(9)Patients with severe mental disorder.(10)Other patients whom the physician decided to be unsuitable for safely carrying out the present study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Osaka University,Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2,Yamadaoka,Suita City, Osaka
TEL
0668793251
heguchi@gesurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetoshi Eguchi |
Organization
Osaka University,Graduate School of Medicine
Division name
Gastroenterological Surgery
Zip code
Address
2-2,Yamadaoka,Suita City, Osaka
TEL
0668793251
Homepage URL
heguchi@gesurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
National Institute of Public Health
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 14 | 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
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031431
