A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer

Recruiting Phase 3 Interventional Study
Advanced Biliary Tract Cancer Biliary Tract Cancer (BTC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
480 (estimated)
Sponsor
J-Pharma Co., Ltd. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: \- Individuals are eligible to be included in the study only if all of the following criteria apply: 1. At least 18 years of age inclusive at the time of signing the informed consent. 2. Provides informed written consent according to local laws or regulations. 3. Able and willi…
Contacts

Masuhiro Yoshitake

+81-3-6432-4270

BeaconBTC@uniphar.us

CONTACT

Kazuo Sekiguchi

+81-3-6432-4270

BeaconBTC@uniphar.us

CONTACT