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Trial record 65 of 167 for:    colon cancer AND Colorectal Neoplasms | ( Map: New Jersey, United States )

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

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ClinicalTrials.gov Identifier: NCT01418222
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
SCRI Development Innovations, LLC
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE August 15, 2011
First Posted Date  ICMJE August 17, 2011
Last Update Posted Date May 30, 2017
Actual Study Start Date  ICMJE September 14, 2011
Actual Primary Completion Date March 18, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
Progression-free survival: time from randomization to tumor progression or death, tumor assessments according to RECIST criteria [ Time Frame: up to 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01418222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2011)
  • Response rate (complete response + partial response) [ Time Frame: up to 4 years ]
  • 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 ]
  • Overall survival [ Time Frame: up to 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE Randomized, Double-Blind, Phase II Study of FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment for Patients With Metastatic Colorectal Cancer
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 metastatic colorectal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: 5-FU
    Intravenous repeating dose
  • Drug: FOLFOX regimen
    Intravenous repeating dose
  • Drug: Placebo
    Intravenous repeating dose
  • Drug: bevacizumab [Avastin]
    Intravenous repeating dose
  • Drug: leucovorin
    Intravenous repeating dose
  • Drug: onartuzumab [MetMAb]
    Intravenous repeating dose
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: 5-FU
    • Drug: FOLFOX regimen
    • Drug: bevacizumab [Avastin]
    • Drug: leucovorin
    • Drug: onartuzumab [MetMAb]
  • Active Comparator: B
    Interventions:
    • Drug: 5-FU
    • Drug: FOLFOX regimen
    • Drug: Placebo
    • Drug: bevacizumab [Avastin]
    • Drug: leucovorin
Publications * Bendell JC, Hochster H, Hart LL, Firdaus I, Mace JR, McFarlane JJ, Kozloff M, Catenacci D, Hsu JJ, Hack SP, Shames DS, Phan SC, Koeppen H, Cohn AL. A Phase II Randomized Trial (GO27827) of First-Line FOLFOX Plus Bevacizumab with or Without the MET Inhibitor Onartuzumab in Patients with Metastatic Colorectal Cancer. Oncologist. 2017 Mar;22(3):264-271. doi: 10.1634/theoncologist.2016-0223. Epub 2017 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2013)
194
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2011)
188
Actual Study Completion Date  ICMJE March 18, 2013
Actual Primary Completion Date March 18, 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01418222
Other Study ID Numbers  ICMJE GO27827
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE SCRI Development Innovations, LLC
Investigators  ICMJE
Study Director: Clinical Trials Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP