A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

Summary

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

Timeline

Start

2016-05-19

Primary completion

2018-02-16

Completion

2026-12

Outcome

Missed primary endpoint

paper neither improved progression-free survival in patients with molecularly unselected, locally advanced or metastatic biliary tract cancer. PMID 34592180 ↗

paper ramucirumab vs placebo hazard ratio 1·12 [80% CI 0·90-1·40], two-sided stratified p=0·48; merestinib vs placebo 0·92 [0·73-1·15], two-sided stratified p=0·64 PMID 34592180 ↗

Publications

• Valle JW, Vogel A, Denlinger CS, He AR, Bai LY, Orlova R, Van Cutsem E, Adeva J, Chen LT, Obermannova R, Ettrich TJ, Chen JS, Wasan H, Girvan AC, Zhang W, Liu J, Tang C, Ebert PJ, Aggarwal A, McNeely SC, Moser BA, Oliveira JM, Carlesi R, Walgren RA, Oh DY. Addition of ramucirumab or merestinib to standard first-line chemotherapy for locally advanced or metastatic biliary tract cancer: a randomised, double-blind, multicentre, phase 2 study. Lancet Oncol. 2021 Oct;22(10):1468-1482. doi: 10.1016/S1470-2045(21)00409-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Merestinib	Small molecule	80 mg	Oral
Subject	Ramucirumab	Monoclonal antibody	8 mg/kg	Intravenous
Background	Cisplatin	Other / unclassified	25 mg/m2	Intravenous
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Indications