Spots Global Cancer Trial Database for A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: A Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With Metastatic Colorectal Cancer
Official Title: A Randomized, Multicenter, Open-label Phase II Study of RO5083945 in Combination With FOLFIRI Versus FOLFIRI Plus Cetuximab or FOLFIRI Alone as Second Line Treatment in Patients With KRAS Wild-type or Mutant Metastatic Colorectal Cancer
Study ID: NCT01326000
Conditions
Study Description
Brief Summary: This randomized, multicenter, open label study will evaluate the safety and efficacy of RO5083945 in combination with FOLFIRI as compared to FOLFIRI plus cetuximab or FOLFIRI alone as second line treatment in patients with metastatic colorectal cancer. Patients will be randomized to receive RO5083945 (1400 mg intravenously on Day 1 and Day 8 and every 2 weeks thereafter) plus FOLFIRI standard iv chemotherapy or FOLFIRI plus cetuximab (400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week) or FOLFIRI alone. 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
, Encinitas, California, United States
, Highland, California, United States
, La Jolla, California, United States
, La Verne, California, United States
, Los Angeles, California, United States
, Los Angeles, California, United States
, San Diego, California, United States
, Harvey, Illinois, United States
, Skokie, Illinois, United States
, Skokie, Illinois, United States
, Charlotte, North Carolina, United States
, Durham, North Carolina, United States
, Winston-Salem, North Carolina, United States
, Sayre, Pennsylvania, United States
, Greenville, South Carolina, United States
, Memphis, Tennessee, United States
, Newcastle, New South Wales, Australia
, Port Macquarie, New South Wales, Australia
, Adelaide, South Australia, Australia
, Box Hill, Victoria, Australia
, EAST Bentleigh, Victoria, Australia
, Frankston, Victoria, Australia
, Bruxelles, , Belgium
, Bruxelles, , Belgium
, Edegem, , Belgium
, Gent, , Belgium
, Leuven, , Belgium
, Bordeaux, , France
, Brest, , France
, Lille, , France
, Paris, , France
, Saint Herblain, , France
, Toulouse, , France
, Essen, , Germany
, Hamburg, , Germany
, Hannover, , Germany
, Heidelberg, , Germany
, Herne, , Germany
, Regensburg, , Germany
, Napoli, Campania, Italy
, Bologna, Emilia-Romagna, Italy
, Udine, Friuli-Venezia Giulia, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Pavia, Lombardia, Italy
, Olsztyn, , Poland
, Szczecin, , Poland
, Sabadell, Barcelona, Barcelona, Spain
, Santander, Cantabria, Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Aberdeen, , United Kingdom
, Belfast, , United Kingdom
, Bournemouth, , United Kingdom
, Cardiff, , United Kingdom
, Dorchester, , United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
, Northwood, , United Kingdom
, Romford, , United Kingdom
, Weston Super Mare, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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