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A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, STUDY EVALUATING THE EFFICACY AND SAFETY OF NANVURANLAT IN PATIENTS WITH PREVIOUSLY TREATED ADVANCED BILIARY TRACT CANCER

Status: Recruiting

This study is for people with advanced biliary tract cancer (cancer of the bile ducts or gallbladder) that cannot be removed with surgery or has spread to other parts of the body. Participants must have previously received one standard chemotherapy treatment for advanced disease. Researchers are studying an investigational medication called nanvuranlat to see if it is safe and effective for treating advanced biliary tract cancer. The study will compare nanvuranlat with standard treatment to learn how well it works, monitor its safety, and better understand how it affects the body and the cancer.

I'm interested

Sex: Male or Female
Age Group: 18 years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• diagnosed with advanced or metastatic biliary tract cancer (including intrahepatic, extrahepatic, or gallbladder cancer) that cannot be removed with surgery
• previously received one platinum-based chemotherapy treatment for advanced disease
• able to carry out light daily activities
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:

• received certain cancer treatments, radiation therapy, or major surgery too recently before starting the study
• active or untreated brain metastases or uncontrolled serious medical conditions
• pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:

Drug: Nanvuranlat, Other: Physician's Best Choice

Conditions:

Cancer

Keywords:

Clinics and Surgery Center (CSC), Beacon-BTC, Biliary tract cancer

Study Contact: Ajay Prakash - praka086@umn.edu
Principal Investigator: Ajay Prakash
Phase: PHASE3
IRB Number: STUDY00026827
See this study on ClinicalTrials.gov

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