UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034080
Receipt No. R000038852
Scientific Title Randomized Controlled Phase 2 Clinical Trial of JPH203 in Patients With Advanced Biliary Tract Cancers.
Date of disclosure of the study information 2018/09/14
Last modified on 2019/03/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Randomized Controlled Phase 2 Clinical Trial of JPH203 in Patients With Advanced Biliary Tract Cancers.
Acronym JPH203-SBECD-P2
Scientific Title Randomized Controlled Phase 2 Clinical Trial of JPH203 in Patients With Advanced Biliary Tract Cancers.
Scientific Title:Acronym JPH203-SBECD-P2
Region
Japan

Condition
Condition Advanced Biliary Tract Cancers
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of JPH203 (25 mg/m2) or Placebo in patients with advanced biliary tract cancers.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival (PFS) by blinded independent central review
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The administration of study drug (JPH203-SBECD, 25mg/m2) is performed (repeated dose for 5days + cession for 9days).
Interventions/Control_2 The administration of Placebo is performed (repeated dose for 5days + cession for 9days).
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) Patient or legally acceptable representative (in case it is difficult to obtain consent from patient due to the lack of consent abillity) whose written informed consent has been obtained for enrollment as a subject for the clinical trial.
2) Japanese patient whose age is older than 20 years at the agreement.
3) Patient diagnosed cytologicallyor histologically as biliary tract cancer (carcinoma of the intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of Vater).
4) Histologically proven adenocarcinoma or adenosquamous carcinoma for patients with EHBD, GB, or AV carcinomas, or adenocarcinoma for IHBD carcinomas.
5) Patient with unresectable biliary tract cancer or recurrent biliary tract cancer.
6) Patient who has measurable regions by RECIST version 1.1 before 4 weeks from the date of enrollment.
7) Patient with standard therapy ineffective or intolerable.
8) Patient whose EOCG performance state is 0-1.
Key exclusion criteria 1) Patient with severe disorders and/or unstable complications except cancers evaluated by investigator.
2) Patient with infection required systemic therapy.
3) Patient with positive HIV-1 antibody or HBs antigen or HCV-RNA.
4) Patient with ECG abnormality
5) Patient with pleural fluids, pericardial effusions or ascites required drainage
Target sample size 33

Research contact person
Name of lead principal investigator
1st name Junji
Middle name
Last name Furuse
Organization Kyorin University Hospital
Division name Medical Oncology
Zip code 181-8611
Address 6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan
TEL 0422-47-5511
Email jfuruse@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name Akinori
Middle name
Last name Masui
Organization J-Pharma Co., Ltd.
Division name Clinical Development Department
Zip code 230-0046
Address 75-1 Onocho, Turumi-ku, Yokohama, Japan
TEL 045-506-1155
Homepage URL
Email masui.a@j-pharma.com

Sponsor
Institute J-Pharma Co., Ltd.
Institute
Department

Funding Source
Organization J-Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Kanagawa Cancer Center IRB
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, Japan
Tel 045-520-2222
Email chiken-jimu4@kcch.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
2018 Year 09 Month 14 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
2018 Year 06 Month 19 Day
Date of IRB
2018 Year 09 Month 07 Day
Anticipated trial start date
2018 Year 09 Month 28 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 10 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038852

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.