A Study Comparing the Efficacy and Safety of Vanucizumab and FOLFOX With Bevacizumab and FOLFOX in Participants With Untreated Metastatic Colorectal Cancer

This is a Phase 2 multicenter, randomized, parallel arms, double-blind study of vanucizumab to evaluate the efficacy and safety of vanucizumab in combination with oxaliplatin, folinic acid, and 5-fluorouracil (5-FU) (mFOLFOX-6) versus bevacizumab (Avastin) + mFOLFOX-6 in participants with previously untreated metastatic colorectal cancer (mCRC). The study consists of 2 parts: a safety run-in open-label, single-arm part (Part 1) and a randomized, parallel-arms, double-blind part (Part 2). During Part 1 at least 6 eligible participants will receive 2000 milligrams (mg) vanucizumab every 2 weeks + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part 2. In Part 2, all eligible participants will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 + vanucizumab or mFOLFOX-6 + bevacizumab. Study treatment (induction and maintenance) will be given on Day 1 of each 14-day cycle. Induction therapy will consist of up to 8 cycles of mFOLFOX-6 plus either bevacizumab or vanucizumab. Maintenance therapy will consist of 5-fluorouracil and folinic acid plus either vanucizumab or bevacizumab for up to 24 months or until disease progression, unacceptable toxicity, Investigator decision or consent withdrawal, whichever occurs first.

本数据集对应一项II期多中心随机双盲平行对照临床试验，旨在评估瓦努珠单抗（vanucizumab）联合奥沙利铂（oxaliplatin）、亚叶酸钙（folinic acid）与5-氟尿嘧啶（5-FU）组成的改良FOLFOX-6方案（mFOLFOX-6），对比贝伐珠单抗（bevacizumab，安维汀Avastin）联合mFOLFOX-6方案，在既往未接受过治疗的转移性结直肠癌（mCRC）受试者中的疗效与安全性。本试验分为两个阶段：安全性导入期开放单臂阶段（Part 1）与随机双盲平行对照阶段（Part 2）。在Part 1阶段中，至少6名符合入组标准的受试者将每2周接受2000毫克（mg）瓦努珠单抗联合mFOLFOX-6方案治疗，以确认Part 2阶段所采用的给药剂量与给药方案。在Part 2阶段中，所有符合入组标准的受试者将以1:1的比例随机分配至两组，分别接受mFOLFOX-6联合瓦努珠单抗，或mFOLFOX-6联合贝伐珠单抗治疗。试验治疗（含诱导治疗与维持治疗）将在每14天周期的第1天进行给药。诱导治疗为最多8个周期的mFOLFOX-6联合贝伐珠单抗或瓦努珠单抗治疗。维持治疗为5-氟尿嘧啶联合亚叶酸钙，外加瓦努珠单抗或贝伐珠单抗，治疗时长最长为24个月，或直至疾病进展、出现不可接受的毒性反应、研究者决定终止试验或受试者撤回知情同意，以先发生者为准。