A Phase II, Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of RO5520985 Plus Folfox Versus Bevacizumab Plus Folfox in Patients with Previously Untreated Metastatic Colorectal Cancer
This is a Phase II multicenter, randomized, parallel arms, double-blind study of RO5520985 to evaluate the efficacy and safety of RO5520985 in combination with oxaliplatin, folinic acid, and 5-fluorouracil (mFOLFOX-6) versus bevacizumab (Avastin) plus mFOLFOX-6 in patients previously untreated metastatic colorectal cancer. The study consists of an safety run-in open-label, single-arm part (Part I) and a randomized, parallel-arms, double-blind part (Part II). During Part I at least 6 eligible patients will be exposed to 2000 mg Q2W RO5520985 + mFOLFOX-6 in order to confirm the dose and schedule that will be used in Part II. All patients in Part I will receive induction and maintenance therapy as described for patients in the experimental arm of Part II. Upon completion of Part I, eligible patients will be randomized in a ratio of 1:1 to receive either mFOLFOX-6 +RO5520985 or mFOLFOX-6 + Avastin. 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 Avastin or RO5520985. During maintenance therapy, patients will receive 5-FU and folinic acid plus either RO5520985 or Avastin for up to 24 months or until disease progession, unacceptable toxicity, Investigator decision or consent withdrawal.