Advanced Biliary Tract Cancers
Conditions
Interventions
The administration of study drug (JPH203-SBECD, 25mg/m2) is performed (repeated dose for 5days + cession for 9days).
The administration of Placebo is performed (repeated dose for 5days + cession for 9
Sponsors
J-Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS) by blinded independent central review | — |
Countries
Japan
Contacts
Public ContactHaruki Kusaka
J-Pharma Co., Ltd. Clinical Development Department
Outcome results
None listed