Status:
COMPLETED
FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
SCRI Development Innovations, LLC
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 me...
Eligibility Criteria
Inclusion
- 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
- 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 \</= 1 months prior to study enrollment
- Significant cardiovascular disease or disorder
- History of abdominal fistula or gastrointestinal perforation \</= 6 months prior to Day 1
- 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
Key Trial Info
Start Date :
September 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2013
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT01418222
Start Date
September 14 2011
End Date
March 18 2013
Last Update
May 30 2017
Active Locations (23)
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1
Almac Clinical Technologies
San Francisco, California, United States, 94105
2
Rocky Mountain Cancer Centers; Bone and Marrow Trans
Denver, Colorado, United States, 80218
3
Florida Cancer Specialists; SCRI
Fort Myers, Florida, United States, 33901
4
Florida Hospital Cancer Inst
Orlando, Florida, United States, 32804