AB046. P-14. TREETOPP: a phase 2/3 study of varlitinib plus capecitabine versus placebo plus capecitabine as second-line treatment in patients with advanced or metastatic biliary tract cancers (BTCs)

ABSTRACT:

Background

Biliary tract cancers (BTCs) are rare and have a poor prognosis. These cancers are often diagnosed at advanced stage with limited treatment options and poor overall survival (OS). Overexpression of epidermal growth factor receptor (EGFR), HER2, HER3, and HER4 vary from 23–57%, 4–13%, 12–23% and 59–60% of BTCs, respectively. Varlitinib is a small molecular tyrosine kinase inhibitor of EGFR, HER2 and HER4 with potent antitumor effect in preclinical BTC models. Varlitinib also demonstrated tumor shrinkage responses and durable disease stabilization in BTC patients in phase IB study.

Methods

A randomized, double-blind, placebo-controlled phase 2 (Part 1)/3 (Part 2) study to compare the efficacy of varlitinib (300 mg BID, every day) versus placebo, when combined wit

SUBMITTER: Javle M 

PROVIDER: S-EPMC6421189 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature