UMIN ID: UMIN000034080
Registered date:14/09/2018
Randomized Controlled Phase 2 Clinical Trial of JPH203 in Patients With Advanced Biliary Tract Cancers.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Advanced Biliary Tract Cancers |
| Date of first enrollment | 2018/11/08 |
| Target sample size | 81 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 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 9days). |
Outcome(s)
| Primary Outcome | Progression Free Survival (PFS) by blinded independent central review |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | J-Pharma Co., Ltd. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | J-Pharma Co., Ltd. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Haruki Kusaka |
| Address | 75-1 Onocho, Turumi-ku, Yokohama, Japan Japan 230-0046 |
| Telephone | 045-506-1155 |
| kusaka.h@j-pharma.com | |
| Affiliation | J-Pharma Co., Ltd. Clinical Development Department |
| scientific contact | |
| Name | Junji Furuse |
| Address | 6-20-2, Shinkawa, Mitaka-shi, Tokyo, Japan Japan |
| Telephone | 0422-47-5511 |
| jfuruse@ks.kyorin-u.ac.jp | |
| Affiliation | Kyorin University Hospital Medical Oncology |