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

Part of paid clinical trials in San Francisco, California.

Sponsor
Genentech, Inc.
Study ID
NCT01418222
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-FU — DRUG
    Intravenous repeating dose
  • FOLFOX regimen — DRUG
    Intravenous repeating dose
  • Placebo — DRUG
    Intravenous repeating dose
  • bevacizumab [Avastin] — DRUG
    Intravenous repeating dose
  • leucovorin — DRUG
    Intravenous repeating dose
  • onartuzumab [MetMAb] — DRUG
    Intravenous repeating dose

Study Details

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.

Key Dates

First listed
Aug 17, 2011
Start date
Sep 14, 2011
Status verified
May 2017
Primary completion
Mar 18, 2013
Completion
Mar 18, 2013

Study Design

Enrollment
194 participants (actual)
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A
  • Active Comparator: B

Primary Outcome Measure

Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria [ Time Frame: up to 4 years ]

Locations (23)

FacilityCityStateZIPSite coordinators
Almac Clinical TechnologiesSan FranciscoCalifornia94105-
Rocky Mountain Cancer Centers; Bone and Marrow TransDenverColorado80218-
Florida Cancer Specialists; SCRIFort MyersFlorida33901-
Florida Hospital Cancer InstOrlandoFlorida32804-
Georgia Cancer Specialists - NorthsideAtlantaGeorgia30341-
University of Chicago; Hematology/OncologyChicagoIllinois60637-
Ingalls Cancer Research CenterHarveyIllinois60426-
Ingalls Memorial Hospital; Cancer Research CenterHarveyIllinois60426-
Baptist Hospital EastLouisvilleKentucky40207-
Center For Cancer and Blood DisordersBethesdaMaryland20817-
Saint Louis Cancer Care, LLPBridgetonMissouri63044-
Research Medical Center - Antibiotic Research Associates, Inc.Kansas CityMissouri64132-
Hem-Onc Assoc of Northern NJMorristownNew Jersey07960-
Oncology Hematology Care IncCincinnatiOhio45242-
Toledo Comm. Onc. ProgramToledoOhio43623-
University of Oklahoma; Stephenson Oklahoma Canc CtrOklahoma CityOklahoma73104-
South Carolina Oncology Associates - SCRIColumbiaSouth Carolina29210-
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303-
SCRI Tennessee Oncology ChattanoogaChattanoogaTennessee37404-
Tennessee Onc., PLLC - SCRINashvilleTennessee37203-
Ctr for Cancer and Blood DisordersFort WorthTexas76104-
South Texas Oncology & Hematology, P.A.San AntonioTexas78229-
Virginia Cancer InstituteRichmondVirginia23226-

Find similar trials in San Francisco, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Almac Clinical Technologies· San Francisco, CARocky Mountain Cancer Centers; Bone and Marrow Trans· Denver, COFlorida Cancer Specialists; SCRI· Fort Myers, FLFlorida Hospital Cancer Inst· Orlando, FLGeorgia Cancer Specialists - Northside· Atlanta, GAUniversity of Chicago; Hematology/Oncology· Chicago, IL

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