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NCT07265674 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Biliary Tract Cancer (BTC) and Advanced Biliary Tract Cancer, sponsored by J-Pharma Co..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 480
- Enrollment target
- 18
- Study locations
NCT07265674: Recruiting Phase 3 study of Biliary Tract Cancer (BTC) and Advanced Biliary Tract Cancer, sponsored by J-Pharma Co..
NCT07265674 is a Phase 3 study of Biliary Tract Cancer (BTC) and Advanced Biliary Tract Cancer that is actively recruiting participants, run by J-Pharma Co.. The registered enrollment target is 480 participants, above the 227-participant average among 4 other Biliary Tract Cancer (BTC) trials with a reported enrollment target (111% higher). The trial reports 18 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07265674, a Phase 3 study of Biliary Tract Cancer (BTC) and Advanced Biliary Tract Cancer, is actively recruiting participants, sponsored by J-Pharma Co..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 480 participants
- Enrollment target
- 18
- Study locations
Study Summary
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.
Primary Outcome
OS is defined as the time from the date of Cycle 1 Day 1 to the date of death from any cause.
Conditions Studied
Interventions
- DRUG Nanvuranlat
- OTHER Physician's Best Choice
Study Locations (18)
California
- City of Hope (Site 107) - Duarte
- University of California at Irvine (Site 101) - Orange
- UCLA Medical Center (Site 117) - Santa Monica
Michigan
- Henry Ford Cancer Center (Site 113) - Detroit
- Karmanos Cancer Center (Site 109) - Detroit
New York
- Rosewell Park Comprehensive Cancer Center (Site 114) - Buffalo
- Memorial Sloan Kettering Cancer Center (Site 108) - New York
Ohio
- University Hospitals Cleveland Medical Center Seidman Cancer Center (Site 111) - Cleveland
- James Cancer Hospital and Solove Research Institute (Site 119) - Columbus
Texas
- University of Texas Southwestern Medical Center (Site 104) - Dallas
- University of Texas MD Anderson Cancer Center (Site 102) - Hosuton
Arizona
- Banner MD Anderson Cancer Center (Site 106) - Gilbert
Kentucky
- Norton Cancer Institute (Site 115) - Louisville
Louisiana
- Ochsner Medical Center (Site 120) - New Orleans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 480 participants |
| Start Date | 2026-01 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
What NCT07265674 shows while recruiting
NCT07265674 is an interventional study that assigns participants to a tested intervention. The registered 480 participants enrollment target is mid-sized for trials with a published cap, above the 227-participant average among 4 other Biliary Tract Cancer (BTC) trials with a reported enrollment target (111% higher).
The record links to 2 conditions, with Biliary Tract Cancer (BTC) appearing as the primary indexed condition, and to 2 interventions - of which Nanvuranlat is the first listed.
NCT07265674 lists 18 locations in 12 states (California, Michigan, New York).
Frequently Asked Questions
What is clinical trial NCT07265674 about?
NCT07265674 is a clinical study titled "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". 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 a...
What is the current status of trial NCT07265674?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 480 participants. The study started on 2026-01. Estimated completion is 2027-10.
What conditions does trial NCT07265674 study?
This clinical trial studies the following conditions: Biliary Tract Cancer (BTC), Advanced Biliary Tract Cancer.
What interventions are being tested in trial NCT07265674?
The interventions under investigation include: Nanvuranlat (DRUG), Physician's Best Choice (OTHER).
Who is sponsoring clinical trial NCT07265674?
This trial is sponsored by J-Pharma Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07265674 being conducted?
This trial has 18 study locations across Arizona, California, Kentucky, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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