ABC08: Ph Ib Acelarin + cisplatin in advanced bililiary tract cancer
Research type
Research Study
Full title
A phase Ib, multi-centre, open-label study of a first-in-class nucleotide analogue Acelarin (NUC-1031) in combination with cisplatin in patients with locally advanced/metastatic biliary tract cancers.
IRAS ID
171155
Contact name
Mairéad McNamara
Contact email
Sponsor organisation
Christie NHS Foundation Trust
Eudract number
2015-000100-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Biliary tract cancers (BTCs) are associated with a high mortality rate (approximately 23 per million population) with an incidence of 0.7% malignant tumours in adults. Surgery offers the only chance of long-term cure; however, due to the aggressive nature of BTC, most patients (>65%) are diagnosed in advanced stages when surgery is not feasible and when palliative chemotherapy is the only treatment available.
A previous trial, the UK NCRN ABC-02 study, has established cisplatin and gemcitabine as the standard of care treatment for patients with BTC. Gemcitabine is a drug which causes cell death by interfering with DNA replication and has been a widely used anti-cancer agent for many years. However, inherent and acquired tumour resistance limit its efficacy.
The primary objective of this study is to assess the safety and determine the recommended phase II dose of Acelarin in combination with cisplatin. Acelarin has been designed specifically to overcome the key cancer resistance mechanisms associated with gemcitabine. Secondary objectives will involve assessing the activity of Acelarin in combination with cisplatin in terms of; progression free survival, overall survival and response rate, as well as exploring the pharmacokinetic profile of the Acelarin/cisplatin combination.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0160
Date of REC Opinion
18 Mar 2015
REC opinion
Further Information Favourable Opinion