NuTide:121 - Patients with Advanced or Metastatic Biliary Tract Cancer
Research type
Research Study
Full title
A Phase III Open-Label, Multi-Centre, Randomised Study Comparing NUC-1031 plus Cisplatin to Gemcitabine plus Cisplatin in Patients with Previously Untreated Locally Advanced or Metastatic Biliary Tract Cancer
IRAS ID
245281
Contact name
Professor Juan Valle
Contact email
Sponsor organisation
NuCana plc
Eudract number
2019-001025-28
Clinicaltrials.gov Identifier
139058, IND
Duration of Study in the UK
2 years, 9 months, 25 days
Research summary
The standard treatment for many people with advanced biliary tract cancer is a chemotherapy drug called gemcitabine in combination with another chemotherapy drug called cisplatin.
The purpose of this study is to test the anti-cancer activity of the study drug, NUC-1031 when given in combination with cisplatin, and to compare it with the standard treatment of gemcitabine in combination with cisplatin in people with biliary tract cancer. This study will also explore the safety of the study treatments and the impact they have on quality of life.
Biliary tract cancer (BTC) is cancer of the biliary system which consists of the liver, gall bladder and bile ducts.The study consists of a screening period (up to 21 days), treatment period, end of treatment visit (30 days after the last dose) and long-term follow-up (every 12 weeks). Each treatment cycle is 21 days long and the study drugs will be given by intravenous (in a vein) infusion on Days 1 and 8 of the 21 day cycle.
Study participants will be randomly assigned (like tossing a coin) to one of two treatment arms, with an equal chance of being assigned to either arm. The study arms are Arm A: NUC-1031 + cisplatin and Arm B: Gemcitabine + cisplatin.
828 participants will be enrolled on the study worldwide with around approximately 31 patients enrolled from the UK. The study sponsor is called NuCana plc.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0135
Date of REC Opinion
6 Jun 2019
REC opinion
Further Information Favourable Opinion