Varlitinib plus capecitabine in second-line advanced biliary tract cancer: a randomized, phase II study (TreeTopp).

ABSTRACT:

Background

Patients with advanced biliary tract cancer who progress on first-line therapy have limited treatment options. The TreeTopp study assessed varlitinib, a reversible small molecule pan-human epidermal growth factor receptor inhibitor, plus capecitabine in previously treated advanced biliary tract cancer.

Patients and methods

This global, double-blind, randomized, placebo-controlled phase II study enrolled patients with confirmed unresectable or metastatic biliary tract cancer and disease progression after one prior line of gemcitabine-containing chemotherapy. Patients received oral varlitinib 300 mg or placebo twice daily (b.i.d.) for 21 days, plus oral capecitabine 1000 mg/m² b.i.d. on days 1-14, in 21-day treatment cycles. Co-primary endpoints were obje

SUBMITTER: Javle MM 

PROVIDER: S-EPMC8685988 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature