A Study of Onartuzumab (MetMAb) in Combination With mFOLFOX6 in Patients With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2) Negative Gastroesophageal Cancer

August 4, 2016 updated by: Hoffmann-La Roche

A Randomized, Phase II, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMAb) In Combination With 5-Fluorouracil, Folinic Acid, And Oxaliplatin (mFOLFOX6) In Patients With Metastatic HER2-Negative Gastroesophageal Cancer

This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2139
    • Queensland
      • Herston, Queensland, Australia, 4029
    • South Australia
      • Woodville South, South Australia, Australia, 5011
    • Victoria
      • East Bentleigh, Victoria, Australia, VIC 3165
      • Heidelberg, Victoria, Australia, 3084
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-720
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 06351
  • Singapore
      • Singapore, Singapore, 119228
      • Singapore, Singapore, 169610
  • Taiwan
      • Tainan, Taiwan, 00704
      • Taipei, Taiwan, 100
      • Taipei, Taiwan, 00112
      • Taoyuan County, Taiwan, 333
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Bangkok, Thailand, 10330
  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Florida
      • Fort Myers, Florida, United States, 33908
      • St Petersburg, Florida, United States, 33705
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Niles, Illinois, United States, 60714
    • New York
      • Albany, New York, United States, 12206
      • New York, New York, United States, 10065
    • Ohio
      • Cincinnati, Ohio, United States, 45219
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78731
      • Bedford, Texas, United States, 76022
      • Garland, Texas, United States, 77060
      • The Woodlands, Texas, United States, 77380
      • Tyler, Texas, United States, 75702
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Richmond, Virginia, United States, 23226
    • Washington
      • Vancouver, Washington, United States, 98684

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, 18 years of age and older
  • Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable for curative therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy >3 months
  • Presence of tissue sample for immunohistochemistry assay of Met receptor and HER2 status (if unknown)
  • Radiographic evidence of disease; measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1); Patients with peritoneal disease would generally be regarded as having evaluable disease and allowed to enter the trial.
  • For women who are not postmenopausal or surgically sterile; agreement to use an adequate method of contraception (e.g., hormonal implant) during the treatment period and for at least 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  • For men: agreement to use a barrier method of contraception during the treatment period and for 90 days after the last dose of onartuzumab/placebo and 6 months after the last dose of oxaliplatin
  • Adequate laboratory values

Exclusion Criteria:

  • HER2-positive tumor (primary tumor or metastasis)
  • Previous chemotherapy for locally advanced or metastatic gastric carcinoma (adjuvant or neoadjuvant chemotherapy must be completed at least 6 months prior to randomization)
  • Prior treatment with investigational drugs that target the hepatocyte growth factor (HGF) or Met pathway
  • History of other malignancy within the previous 5 years, except for appropriately treated and presumed cured carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, and localized prostate cancer
  • Receipt of an investigational drug within 28 days prior to study start
  • Clinically significant gastrointestinal abnormalities, except from gastric cancer (e.g., Crohn's disease)
  • Significant history of cardiac disease
  • Significant vascular disease
  • Infection with human immunodeficiency virus, hepatitis B, or hepatitis C

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Onartuzumab (MetMAb) with mFOLFOX6
Onartuzumab (MetMAb) in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)
Drug: Onartuzumab (MetMAb)
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: Levofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: 5-Fluorouracil
5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Placebo Comparator: Placebo with mFOLFOX6
Placebo in combination with mFOLFOX6 (modified 5-fluorouracil, folinic acid [leucovorin], and oxaliplatin)
Drug: Oxaliplatin
Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: Folinic acid
Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: Levofolinic acid
If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: 5-Fluorouracil
5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
Drug: Placebo
Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS) in all patients
Time Frame: Up to 18 months
Up to 18 months
Progression-free survival (PFS) in patients with Met-positive tumors
Time Frame: Up to 18 months
Up to 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: 18 months
18 months
Safety: incidence of adverse events
Time Frame: 18 months
18 months
Overall response rate (ORR)
Time Frame: 18 months
18 months
Duration of response (DOR)
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 2, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 3, 2012

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YO28252
  • 2012-000858-57 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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