ABC-08: Phase Ib Trial of Acelarin in Combination With Cisplatin in Locally Advanced/ Metastatic Biliary Tract Cancers

Phase 1 Completed 21 enrolled The Christie NHS Foundation Trust

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the recommended phase II dose, and to assess the safety of acelarin in combination with cisplatin in patients with locally advanced/ metastatic biliary tract cancers.

Timeline

Start: 2016-01
Primary completion: 2019-03
Completion: 2019-03

Publications

McNamara MG, Bridgewater J, Palmer DH, Faluyi O, Wasan H, Patel A, Ryder WD, Barber S, Gnanaranjan C, Ghazaly E, Evans TRJ, Valle JW. 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). Oncologist. 2021 Apr;26(4):e669-e678. doi: 10.1002/onco.13598. Epub 2020 Dec 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	FOSGEMCITABINE PALABENAMIDE	Small molecule	500 mg/m2	—
Subject	FOSGEMCITABINE PALABENAMIDE	Small molecule	625 mg/m2	—
Subject	FOSGEMCITABINE PALABENAMIDE	Small molecule	725 mg/m2	—
Subject	FOSGEMCITABINE PALABENAMIDE	Small molecule	925 mg/m2	—
Background	Cisplatin	Other / unclassified	25 mg/m2	—

ABC-08: Phase Ib Trial of Acelarin in Combination With Cisplatin in Locally Advanced/ Metastatic Biliary Tract Cancers

Summary

Timeline

Publications

Drugs

Indications