Phase II randomized, double-blind, placebo-controlled study of AMG 386 (trebananib) in combination with cisplatin and capecitabine in patients with metastatic gastro-oesophageal cancer
MM Eatock, NC Tebbutt, CL Bampton, AH Strickland, M Valladares-Ayerbes, A Swieboda-Sadlej, E Van Cutsem, N Nanayakkara, Y-N Sun, ZD Zhong, MB Bass, AH Adewoye, G Bodoky
ANNALS OF ONCOLOGY | OXFORD UNIV PRESS | Published : 2013
BACKGROUND: We evaluated AMG 386, an investigational peptibody that neutralizes the interaction between angiopoietins-1 and -2 and the Tie2 receptor, combined with cisplatin/capecitabine (CX) as first-line treatment for metastatic gastro-oesophageal cancer. PATIENTS AND METHODS: Patients with metastatic gastric, gastro-oesophageal junction, or distal oesophageal adenocarcinoma were randomized 1:1:1 to CX (cisplatin 80 mg/m(2) IV Q3W; capecitabine 1000 mg/m(2) P.O. BID for 14 days Q3W) plus intravenous AMG 386 10 mg/kg QW (Arm A) or 3 mg/kg QW (Arm B), or placebo QW (Arm C). The primary end point was estimated progression-free survival (PFS). RESULTS: A total of 171 patients were enrolled. Me..View full abstract
This work was funded by Amgen Inc.The authors have declared the following conflicts of interest: NCT has conducted research sponsored by Amgen Inc.; MV-A has received research funding from Roche and Amgen Inc. and has acted as a speaker and consultant for Amgen Inc., Merck-Serono, and Roche; NN is an employee of Quintiles and works as a contractor for Amgen Inc.; Y-NS, MBB, ZDZ, and AHA are employees of and shareholders in Amgen Inc.; MME, CLB, AS, AS-S, EVC, and GB have declared no conflicts of interest.