UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034080 |
|---|---|
| Receipt number | 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 | 2023/09/30 20:58:47 |
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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
81
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
jfuruse@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Kusaka |
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
kusaka.h@j-pharma.com
Sponsor or person
Institute
J-Pharma Co., Ltd.
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
https://meetings.asco.org/abstracts-presentations/217774
Number of participants that the trial has enrolled
106
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median (minimum and maximum) age that patients had obtained informed consents in FAS was 68.0 (34 and 83) and 63.0 (38 and 79) years in the JPH203 and placebo groups (in that order), respectively, and the mean was 66.1 (standard deviation = 11.6) and 62.1 (standard deviation = 10.7) years. Gender was 60.9% and 60.0% for males and 39.1% and 40.0% for females, 52.2% and 51.4% for subjects with prior primary resection, and 47.8% and 48.6% for subjects without a history of prior primary resection. The subgroups of biliary tract cancer was the intrahepatic cholangiocarcinoma (IHC) in 39.1% and 48.6%, gallbladder cancer (GBC) in 23.2% and 22.9%, extrahepatic
cholangiocarcinoma (EHC) in 21.7% and 17.1%, and ampulla of Vater cancer
(AVC) in 15.9% and 11.4%.
Participant flow
Informed consent was obtained from 211
patients with 106 patients enrolled into the study. The 106 patients were randomly assigned to the JPH203 group (N=70 patients) or placebo group (N=36 patients).
One patient assigned to the placebo group discontinued the study before receiving the study drug, and 105 patients (70 pts in the JPH203 group and 35 pts in the placebo group) received the study drugs. Two patients (one in the JPH203 group and one in the placebo group) were still receiving study drug at the timing of the data cutoff, and 103 patients (69 pts in the JPH203 group and 34 pts in the placebo group) discontinued study drug in a blinded treatment period.
The number of patients in the primary endpoint analysis population, FAS was 69 pts and 54 pts in the JPH203 and placebo groups, respectively.
The number of patients in the safety analysis population, SAFETY, was 70 pts and 35 pts in the JPH203 and placebo groups, respectively.
Adverse events
The adverse events that were reported in over 5.0% in the JPH203 group were decreased appetite, malaise, cholangitis, constipation, nausea, pyrexia, diarrhea, insomnia, vomiting, cancer pain, pruritus, hypertension, and stomatitis.
Of these adverse events, those that occurred at least 5% more frequently in the JPH203 group than in the placebo group were cholangitis (10/70 pts (14.3%) in the JPH203 group and 3/35 pts (8.6%) in the placebo group) and insomnia (8/70 pts (11.6%) in the JPH203 group, and 2/35 pts (5.7%) in the placebo group).
With the exception of cholangitis and Insomnia, most of the adverse events that were reported in over 5.0% did not differ significantly between the JPH203 group and the placebo group, and were considered that there is no major safety concern.
Cholangitis was judged with no casusal relationship to the study drug by the investigators.
However in the incident rate of cholangitisto in the JPH203 group was higher than in the placebo group and the its severity is the highest, so cholangitis was the event to be considered.
Outcome measures
All time-to-event endpoints were estimated using the Kaplan-Meier method. A stratified log-rank test was used to assess statistical significance. A Cox hazard model was used to estimate the Hazard Ratio (HR) and the 95% CI for PFS, in comparing the nanvuranlat and placebo groups. Stratification of primary endpoint was BTC subtype and history of resection of the primary lesion.
In the primary endpoint of PFS according to blinded, independent central image assessment,the HR for PFS in the JPH203 group versus the placebo group was 0.557 (95% confidence interval, 0.3435-0.9029) by stratified cox proportional hazards model.The two-sided p-value by stratified log-rank test was 0.0164.
The JPH203 group significantly prolonged PFS according to blinded, independent central image assessment, the primary endpoint in the FAS, versus the placebo group.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 11 | Month | 08 | Day |
Last follow-up date
| 2022 | Year | 11 | 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
| 2023 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038852
