Spots Global Cancer Trial Database for A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer
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Trial Identification
Brief Title: A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer
Official Title: A Randomized, Phase III, 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, MET-Positive Gastroesophageal Cancer
Study ID: NCT01662869
Conditions
Study Description
Brief Summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, 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
, Brugge, , 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, , Czech Republic
, Olomouc, , Czech Republic
, Angers, , France
, Avignon, , France
, Besancon, , France
, Brest, , France
, Clichy, , France
, Marseille, , France
, Paris, , France
, Paris, , France
, Paris, , France
, St Herblain, , France
, Toulouse, , France
, Bochum, , Germany
, Essen, , Germany
, Hamburg, , Germany
, Leipzig, , Germany
, Ludwigsburg, , Germany
, Mannheim, , Germany
, Marburg, , Germany
, München, , Germany
, Guatemala, , 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
, Roma, Lazio, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Torino, Piemonte, Italy
, Firenze, Toscana, Italy
, Prato, Toscana, Italy
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Kuala Lumpur, , Malaysia
, Sabah, , Malaysia
, Aguascalientes, , Mexico
, Monterrey, , Mexico
, Oaxaca, , Mexico
, Panama, , Panama
, Bydgoszcz, , Poland
, Gdansk, , Poland
, Krakow, , Poland
, Lublin, , Poland
, Rybnik, , Poland
, Warszawa, , Poland
, Ivanovo, , Russian Federation
, Omsk, , Russian Federation
, Ryazan, , Russian Federation
, Samara, , Russian Federation
, Tula, , Russian Federation
, Singapore, , Singapore
, Elche, Alicante, Spain
, Santander, Cantabria, Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Zaragoza, , Spain
, Luzern, , Switzerland
, Zürich, , 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
, Edirne, , Turkey
, Erzurum, , Turkey
, Malatya, , Turkey
, Samsun, , Turkey
, Sıhhiye, ANKARA, , Turkey
, Bristol, , United Kingdom
, Cardiff, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Southampton, , United Kingdom
, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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