FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2013-03-18
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of FOLFOX/bevacizumab with onartuzumab (MetMAb) versus placebo as first-line treatment in patients with metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Collaborator: SCRI Development Innovations, LLC
• Treatments: Antibodies, Monoclonal; Bevacizumab; Leucovorin

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Histologically or cytologically confirmed adenocarcinoma of the colon or rectum in patients with metastatic (Stage IV) disease

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

• Measurable disease by RECIST criteria

• Adequate organ system function, as defined by protocol

Exclusion Criteria:

• Prior systemic or radiation therapy for metastatic colorectal cancer

• Adjuvant chemotherapy (and/or chemoradiation) for colorectal cancer within 12 months prior to date of diagnosis of metastatic disease

• Previously untreated brain metastases

• History of hypersensitivity to active or inactive excipients of any component of treatment, or known dipyrimidine dehydrogenase deficiency

• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)

• History of hematemesis or hemoptysis
• Significant cardiovascular disease or disorder

• History of abdominal fistula or gastrointestinal perforation1

• Positive for hepatitis B, hepatitis C or HIV infection

• Other active cancers or history of treatment for invasive cancer within the last 5 years, except for non-melanoma skin cancer