A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer
NCT ID: NCT01662869
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
564 participants
INTERVENTIONAL
2012-11-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Onartuzumab+mFOLFOX6
Participants will receive onartuzumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion + mFOLFOX6 (oxaliplatin, folinic acid, and 5-fluoruracil) regimen. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with onartuzumab. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with onartuzumab will continue treatment with onartuzumab until disease progression, unacceptable toxicity, or death.
5-Fluoruracil
Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m\^2) IV bolus and then 2400 mg/m\^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Folinic acid
Participants will receive folinic acid 400 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Onartuzumab
Participants will receive onartuzumab 10 mg/kg IV infusion on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
Oxaliplatin
Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Placebo+mFOLFOX6
Participants will receive onartuzumab matching placebo + mFOLFOX6. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with placebo. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with placebo will continue treatment with placebo until disease progression, unacceptable toxicity, or death.
5-Fluoruracil
Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m\^2) IV bolus and then 2400 mg/m\^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Folinic acid
Participants will receive folinic acid 400 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Oxaliplatin
Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
Interventions
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5-Fluoruracil
Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m\^2) IV bolus and then 2400 mg/m\^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Folinic acid
Participants will receive folinic acid 400 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Onartuzumab
Participants will receive onartuzumab 10 mg/kg IV infusion on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
Oxaliplatin
Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
Placebo
Participants will receive onartuzumab matching placebo on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Life expectancy greater than (\>) 3 months
* Presence of tissue sample for IHC assay of MET receptor and HER2 status
* Tumor (primary or metastatic lesion) defined as MET-positive by IHC
* Measurable disease or non-measurable but evaluable disease, according to the RECIST v1.1; Participants 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 (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
Exclusion Criteria
* 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 human growth factor (HGF) or MET pathway
* History of another 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
* Pregnancy or lactation
* Receipt of an investigational drug within 28 days prior to study start
* Clinically significant gastrointestinal abnormalities, apart from gastric cancer, including uncontrolled inflammatory gastrointestinal diseases
* Significant history of cardiac disease
* Significant vascular disease
* Serious active infection at the time of randomization, or other serious underlying medical conditions that would impair the ability of the participant to receive protocol treatment
* Infection with human immunodeficiency virus, hepatitis B, or hepatitis C
* Radiotherapy within 4 weeks before start of study treatment
* Major surgery within 4 weeks before start of study treatment, without complete recovery
* Any condition (psychological, geographical) that does not permit compliance with study and follow-up procedures
* Peripheral neuropathy
* Prior unanticipated severe reaction to fluoropyrimidine therapy
* Known sensitivity or contraindication to any component of study treatment
* Active gastrointestinal bleeding
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Angeles, California, United States
Denver, Colorado, United States
Fort Myers, Florida, United States
St. Petersburg, Florida, United States
Chicago, Illinois, United States
Albany, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Providence, Rhode Island, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Tyler, Texas, United States
Vancouver, Washington, United States
Port Macquarie, New South Wales, Australia
Sydney, New South Wales, Australia
Herston, Queensland, Australia
Box Hill, Victoria, Australia
East Bentleigh, Victoria, Australia
Nedlands, Western Australia, Australia
Bruges, , Belgium
Leuven, , Belgium
Sint-Niklaas, , Belgium
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Brno, , Czechia
Olomouc, , Czechia
Angers, , France
Avignon, , France
Besançon, , France
Brest, , France
Clichy, , France
Marseille, , France
Paris, , France
Paris, , France
Paris, , France
Saint-Herblain, , France
Toulouse, , France
Bochum, , Germany
Essen, , Germany
Hamburg, , Germany
Leipzig, , Germany
Ludwigsburg, , Germany
Mannheim, , Germany
Marburg, , Germany
München, , Germany
Guatemala City, , Guatemala
Hong Kong, , Hong Kong
Hong Kong, , Hong Kong
Jerusalem, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Catanzaro, Calabria, Italy
Udine, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Florence, Tuscany, Italy
Prato, Tuscany, Italy
Sabah, Sabah, Malaysia
Kuala Lumpur, , Malaysia
Aguascalientes, , Mexico
Monterrey, , Mexico
Oaxaca City, , Mexico
Panama City, , Panama
Bydgoszcz, , Poland
Gdansk, , Poland
Krakow, , Poland
Lublin, , Poland
Rybnik, , Poland
Warsaw, , Poland
Ivanovo, , Russia
Omsk, , Russia
Ryazan, , Russia
Samara, , Russia
Tula, , Russia
Singapore, , Singapore
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Elche, Alicante, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Santander, Cantabria, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Zaragoza, Zaragoza, Spain
Lucerne, , Switzerland
Zurich, , Switzerland
Changhua, , Taiwan
Kaohisung, , Taiwan
Taichung, , Taiwan
Taichung, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Rai, , Thailand
Hat Yai, , Thailand
Lopburi, , Thailand
Antalya, , Turkey (Türkiye)
Edirne, , Turkey (Türkiye)
Erzurum, , Turkey (Türkiye)
Malatya, , Turkey (Türkiye)
Samsun, , Turkey (Türkiye)
Sıhhiye, Ankara, , Turkey (Türkiye)
Bristol, , United Kingdom
Cardiff, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Southampton, , United Kingdom
Sutton, , United Kingdom
Countries
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References
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Shah MA, Bang YJ, Lordick F, Alsina M, Chen M, Hack SP, Bruey JM, Smith D, McCaffery I, Shames DS, Phan S, Cunningham D. Effect of Fluorouracil, Leucovorin, and Oxaliplatin With or Without Onartuzumab in HER2-Negative, MET-Positive Gastroesophageal Adenocarcinoma: The METGastric Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):620-627. doi: 10.1001/jamaoncol.2016.5580.
Other Identifiers
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2012-001402-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
YO28322
Identifier Type: -
Identifier Source: org_study_id