A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
NCT ID: NCT01577173
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
PHASE2
122 participants
INTERVENTIONAL
2012-07-31
2015-06-30
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
NONE
Study Groups
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A: MEHD7945A
MEHD7945A
1100 mg iv every 2 weeks
B: Cetuximab
cetuximab
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
Interventions
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MEHD7945A
1100 mg iv every 2 weeks
cetuximab
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed Stage III or IV recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
* Progressive disease on or after first-line platinum-based chemotherapy regimen for R/M SCCHN (maximum of 6 cycles)
* No more than one platinum-based chemotherapy regimen for R/M SCCHN is allowed
* Prior platinum-based treatment as definitive chemo/radiotherapy for locally advanced disease is allowed if completed/terminated \>/= 6 months before the platinum-based regimen for R/M SCCHN
* Consent to provide archival tumor tissue for biomarker testing
* Measurable disease per RECIST v1.1
* ECOG performance status of 0, 1 or 2
* Adequate hematologic, renal and liver function
Exclusion Criteria
* Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
* This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib
* Prior treatment with an EGFR inhibitor is allowed if it was administered as part of definitive therapy for locally advanced disease and completed \>/=1 year before study enrollment
* Leptomeningeal disease as the only manifestation of the current malignancy
* Active infection requiring iv antibiotics
* Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone fractures)
* History of heart failure or serious cardiac arrhythmia
* History of myocardial infarction within 6 months of Cycle 1, Day 1
* Clinically significant liver disease, including active viral, alcoholic or other hepatitis, cirrhosis, or current alcohol abuse
* HIV infection
* Primary central nervous system (CNS) malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
* Pregnant or lactating women
* Malignancies other than SCCHN within 5 years prior to randomization, with the exception of adequately treated basal or squamous cell skin cancer and carcinoma in situ of the cervix
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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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
Saint 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
Rousse, , Bulgaria
Sofia, , Bulgaria
Clichy, , France
Lyon, , France
Villejuif, , France
Berlin, , Germany
Essen, , Germany
Debrecen, , Hungary
Győr, , Hungary
Szolnok, , Hungary
Udine, Friuli Venezia Giulia, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Orbassano, Piedmont, Italy
Turin, Piedmont, Italy
Brasov, , Romania
Cluj-Napoca, , Romania
Cluj-Napoca, , Romania
Timișoara, , Romania
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Salamanca, Salamanca, Spain
Valencia, Valencia, Spain
Coventry, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Sutton, , United Kingdom
Countries
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Other Identifiers
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2011-005539-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO28076
Identifier Type: -
Identifier Source: org_study_id