Spots Global Cancer Trial Database for Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)
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Trial Identification
Brief Title: Safety and Efficacy Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI as Second Line Therapy in Participants With KRAS Wild-Type Metastatic Colorectal Cancer (mCRC)
Official Title: A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wildtype Metastatic Colorectal Cancer
Study ID: NCT01652482
Conditions
Study Description
Brief Summary: This open-label, randomized, multicenter, Phase 2 study will evaluate the safety and efficacy of MEHD7945A when combined with FOLFIRI (folinic acid \[leucovorin\], 5-fluorouracil \[5-FU\], and irinotecan) chemotherapy as compared to cetuximab plus FOLFIRI in participants with Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) wild-type mCRC who have progressed after first-line oxaliplatin-containing chemotherapy for metastatic disease. Participants will be randomized to receive FOLFIRI chemotherapy plus either MEHD7945A or cetuximab. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Bakersfield, California, United States
, Fullerton, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, San Luis Obispo, California, United States
, Santa Barbara, California, United States
, Aurora, Colorado, United States
, Orange Park, Florida, United States
, Harvey, Illinois, United States
, Paducah, Kentucky, United States
, Rockville, Maryland, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, Detroit, Michigan, United States
, Jefferson City, Missouri, United States
, Las Vegas, Nevada, United States
, Philadelphia, Pennsylvania, United States
, Kirkland, Washington, United States
, Seattle, Washington, United States
, Darlinghurst, New South Wales, Australia
, New Lambton Heights, New South Wales, Australia
, St. Leonards, New South Wales, Australia
, Sydney, New South Wales, Australia
, Waratah, New South Wales, Australia
, Wollongong, New South Wales, Australia
, Herston, Queensland, Australia
, Southport, Queensland, Australia
, Adelaide, South Australia, Australia
, Frankston, Victoria, Australia
, Bruxelles, , Belgium
, Charleroi, , Belgium
, Haine-Saint-Paul, , Belgium
, Leuven, , Belgium
, Liège, , Belgium
, Creteil, , France
, Lyon, , France
, Paris, , France
, Villejuif, , France
, Dresden, , Germany
, München, , Germany
, München, , Germany
, Stuttgart, , Germany
, Trier, , Germany
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Orbassano, Piemonte, Italy
, Pisa, Toscana, Italy
, Padova, Veneto, Italy
, Auckland, , New Zealand
, Christchurch, , New Zealand
, Dunedin, , New Zealand
, Tauranga, , New Zealand
, Brasov, , Romania
, Bucharest, , Romania
, Bucuresti, , Romania
, Iasi, , Romania
, Barcelona, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Valencia, , Spain
, Aberdeen, , United Kingdom
, London, , United Kingdom
, Oxford, , United Kingdom
, Wirral, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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