Spots Global Cancer Trial Database for A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
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Trial Identification
Brief Title: A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
Official Title: A Phase II, Open-Label, Randomized Study of MEDH7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Progressed During or Following Platinum-based Chemotherapy
Study ID: NCT01577173
Conditions
Study Description
Brief Summary: This phase II, open-label, randomized study will evaluate the efficacy and safety of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck who have progressed during or following platinum-based chemotherapy. Patients will be randomized to receive either MEHD7945A 1100 mg intravenously (iv) every 2 weeks or cetuximab 400 mg/m2 iv loading dose followed by 250 mg/m2 iv weekly. Patients treated with cetuximab (Arm B) may cross-over to MEHD7945A (Arm A) upon central confirmation of progressive disease and upon meeting eligibility criteria. Anticipated time on study treatment is until disease progression or intolerable toxicity occurs.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Stanford, California, United States
, Aurora, Colorado, United States
, Miami, Florida, United States
, Chicago, Illinois, United States
, Paducah, Kentucky, United States
, Baltimore, Maryland, United States
, Boston, Massachusetts, United States
, Boston, Massachusetts, United States
, St Joseph, Missouri, United States
, New York, New York, United States
, Chapel Hill, North Carolina, United States
, Charleston, South Carolina, United States
, Knoxville, Tennessee, United States
, Madison, Wisconsin, United States
, Darlinghurst, New South Wales, Australia
, Waratah, New South Wales, Australia
, Wollongong, New South Wales, Australia
, Brisbane, Queensland, Australia
, Kurralta Park, South Australia, Australia
, Melbourne, Victoria, Australia
, Edegem, , Belgium
, Namur, , Belgium
, Pleven, , Bulgaria
, Ruse, , Bulgaria
, Sofia, , Bulgaria
, Clichy, , France
, Lyon, , France
, Villejuif, , France
, Berlin, , Germany
, Essen, , Germany
, Debrecen, , Hungary
, Gyor, , Hungary
, Szolnok, , Hungary
, Udine, Friuli-Venezia Giulia, Italy
, Milano, Lombardia, Italy
, Milano, Lombardia, Italy
, Orbassano, Piemonte, Italy
, Torino, Piemonte, Italy
, Brasov, , Romania
, Cluj-Napoca, , Romania
, Cluj-Napoca, , Romania
, Timisoara, , Romania
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Salamanca, , Spain
, Valencia, , Spain
, Coventry, , United Kingdom
, Glasgow, , United Kingdom
, London, , United Kingdom
, Sutton, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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