NCT04163900

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 773 (actual)
• Sponsor: NuCana plc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	NUC-1031	IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes
DRUG	Gemcitabine	IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert
DRUG	Cisplatin	IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol

Timeline

• Start date: 2019-12-24
• Primary completion: 2022-03-02
• Completion: 2022-04-05
• First posted: 2019-11-15
• Last updated: 2023-05-24
• Results posted: 2023-05-24

Locations

125 sites across 15 countries: United States, Australia, Canada, Czechia, France, Germany, Hungary, Italy, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study