A phase Ib study of NUC-1031 in combination with cisplatin for the first-line treatment of patients with advanced biliary tract cancer (ABC-08).

CONCLUSIONS: This is the first study reporting on the combination of NUC-1031 with cisplatin in ABC and demonstrated a favourable safety profile; 725mg/m2 NUC-1031 in combination with cisplatin is undergoing phase III trial evaluation in ABC. ClinicalTrials.gov reference: NCT02351765, EudraCT: 2015-000100-26 IMPLICATIONS FOR PRACTICE: The prognosis for patients with advanced biliary tract cancer (ABC) is approximately one year and new treatment options are required. The cisplatin/gemcitabine combination is standard first-line treatment for patients with ABC. NUC-1031 is a phosphoramidate transformation of gemcitabine and is designed to enhance efficacy by maximising intra-tumoural active metabolites. This phase Ib study (ABC-08) demonstrated a favourable safety profile of NUC-1031 in combination with cisplatin for the first-line treatment of patients with ABC, and 725mg/m2 NUC-1031 was recommended in combination with cisplatin for phase III trial evaluation; the NuTide:121 global randomised study is currently enrolling. PMID: 33210382 [PubMed - as supplied by publisher]
Source: The Oncologist - Category: Cancer & Oncology Authors: Tags: Oncologist Source Type: research