Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

Official Title

A Phase III Open-Label, Multi-Centre, Randomized Study Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer

Summary:

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: - The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care - The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care

Trial Description

Primary Outcome:

• Overall survival (OS)
• Objective response rate (ORR)

• Progression-free survival (PFS)
• Duration of response (DoR)
• 12-month survival
• 18-month survival
• Disease control rate (DCR)
• Safety and tolerability
• Maximum observed plasma concentration (Cmax) of NUC-1031, dFdC and dFdU will be compared to existing data using simulations in Arm A only
• Area under the plasma concentration-time curve (AUC) of NUC-1031, dFdC and dFdU will be compared to existing data using simulations in Arm A only
• Elimination half-life (t½) of NUC-1031, dFdC and dFdU using descriptive statistics in Arm A only
• Terminal elimination rate constant (λz) of NUC-1031, dFdC and dFdU using descriptive statistics in Arm A only
• Clearance of NUC-1031, dFdC and dFdU will be compared to existing data using simulations in Arm A only
• Volume of distribution of NUC-1031, dFdC and dFdU will be compared to existing data using simulations in Arm A only
• Comparison of patient-reported quality of life (QoL) scores in Arm A and Arm B
• Comparison of patient-reported quality of life (QoL) scores in Arm A and Arm B

View this trial on ClinicalTrials.gov