Condition: Advanced Biliary Tract Cancer · Biliary Tract Cancer (BTC) · Sponsor: J-Pharma Co., Ltd.
This study is designed to 1) select a dose regimen for continued development and 2) evaluate nanvuranlat versus Physicians Best Choice (PBC) (FOLFOX, FOLFIRI, or Best Supportive Care (BSC)) in participants aged 18 years and over with BTC. Participants enrolling in Part A the trial will be randomly assigned to receive 1 of 3 nanvuranlat dose regimens or PBC. In Part B, participants will be randomly assigned to receive nanvuranlat or PBC. Participants will receive treatment every 2 weeks for as long as they do not experience safety issues, or their cancer gets worse, and the study doctor feels they should stop treatment. Health measurements including physical examinations, vital signs, ECGs, and safety laboratory tests will be performed to monitor safety, and tumor imaging will be performed to monitor cancer response to treatment. Other exploratory makers will be measured to better understand how nanvuranlat works.
This description comes directly from the study's public registry record.
Masuhiro Yoshitake · +81-3-6432-4270 · BeaconBTC@uniphar.us
Kazuo Sekiguchi · +81-3-6432-4270 · BeaconBTC@uniphar.us
Always discuss trial participation with your own doctor first.
| City of Hope (Site 107) | Duarte, California, United States | Recruiting |
| University of California at Irvine (Site 101) | Orange, California, United States | Recruiting |
| UCLA Medical Center (Site 117) | Santa Monica, California, United States | Not Yet Recruiting |
| Moffitt Cancer Center Magnolia Campus (Site 123) | Tampa, Florida, United States | Recruiting |
| City of Hope - Chicago Cancer Center (Site 128) | Zion, Illinois, United States | Recruiting |
| Norton Cancer Institute (Site 115) | Louisville, Kentucky, United States | Recruiting |
| Ochsner Medical Center (Site 120) | New Orleans, Louisiana, United States | Not Yet Recruiting |
| Karmanos Cancer Center (Site 109) | Detroit, Michigan, United States | Recruiting |
| Masonic Cancer Center, University of Minnesota (Site 116) | Minneapolis, Minnesota, United States | Recruiting |
| Comprehensive Cancer Centers of Nevada - Central Valley (Site 124) | Las Vegas, Nevada, United States | Recruiting |
| Rutgers Cancer Institute of New Jersey (Site 103) | New Brunswick, New Jersey, United States | Recruiting |
| Rosewell Park Comprehensive Cancer Center (Site 114) | Buffalo, New York, United States | Not Yet Recruiting |
+ 6 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07265674