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

This study is ongoing, but not recruiting participants.
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
Genentech Identifier:
First received: August 15, 2011
Last updated: February 17, 2014
Last verified: February 2014

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.

Condition Intervention Phase
Colorectal Cancer
Drug: onartuzumab [MetMAb]
Drug: Placebo
Drug: bevacizumab [Avastin]
Drug: FOLFOX regimen
Drug: leucovorin
Drug: 5-FU
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate (complete response + partial response) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Time to treatment failure: from randomization to treatment discontinuation for any reason including disease progression, treatment toxicity, and death [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 194
Study Start Date: September 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: onartuzumab [MetMAb]
Intravenous repeating dose
Drug: bevacizumab [Avastin]
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose
Drug: leucovorin
Intravenous repeating dose
Drug: 5-FU
Intravenous repeating dose
Active Comparator: B Drug: Placebo
Intravenous repeating dose
Drug: bevacizumab [Avastin]
Intravenous repeating dose
Drug: FOLFOX regimen
Intravenous repeating dose
Drug: leucovorin
Intravenous repeating dose
Drug: 5-FU
Intravenous repeating dose


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 </= 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01418222

  Show 22 Study Locations
Sponsors and Collaborators
SCRI Development Innovations, LLC
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech Identifier: NCT01418222     History of Changes
Other Study ID Numbers: GO27827
Study First Received: August 15, 2011
Last Updated: February 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Protective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses processed this record on April 21, 2014