A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
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
2 other identifiers
interventional
122
11 countries
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 head-and-neck-cancer
Started Jul 2012
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2012
CompletedFirst Posted
Study publicly available on registry
April 13, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 2, 2016
November 1, 2016
2.9 years
April 11, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (tumor assessments according to RECIST criteria)
approximately 24 months
Secondary Outcomes (8)
Objective response: complete response or partial response
approximately 24 months
Disease control: complete response, partial response or stable disease
approximately 24 months
Duration of objective response
approximately 24 months
Time to disease progression
approximately 24 months
Overall survival
approximately 24 months
- +3 more secondary outcomes
Study Arms (2)
A: MEHD7945A
EXPERIMENTALB: Cetuximab
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Adult patients, \>/= 18 years of age
- 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
You may not qualify if:
- Nasopharyngeal cancer
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (51)
Unknown Facility
Stanford, California, 94305, United States
Unknown Facility
Aurora, Colorado, 80045, United States
Unknown Facility
Miami, Florida, 33176, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Paducah, Kentucky, 42003, United States
Unknown Facility
Baltimore, Maryland, 21204, United States
Unknown Facility
Boston, Massachusetts, 02114, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Saint Joseph, Missouri, 64507, United States
Unknown Facility
New York, New York, 10011, United States
Unknown Facility
Chapel Hill, North Carolina, 27599-7295, United States
Unknown Facility
Charleston, South Carolina, 29425, United States
Unknown Facility
Knoxville, Tennessee, 37909, United States
Unknown Facility
Madison, Wisconsin, 53705-2275, United States
Unknown Facility
Darlinghurst, New South Wales, 2010, Australia
Unknown Facility
Waratah, New South Wales, 2298, Australia
Unknown Facility
Wollongong, New South Wales, 2500, Australia
Unknown Facility
Brisbane, Queensland, 4029, Australia
Unknown Facility
Kurralta Park, South Australia, 5037, Australia
Unknown Facility
Melbourne, Victoria, 3002, Australia
Unknown Facility
Edegem, 2650, Belgium
Unknown Facility
Namur, 5000, Belgium
Unknown Facility
Pleven, 5800, Bulgaria
Unknown Facility
Rousse, 7000, Bulgaria
Unknown Facility
Sofia, 1303, Bulgaria
Unknown Facility
Clichy, 92118, France
Unknown Facility
Lyon, 69373, France
Unknown Facility
Villejuif, 94805, France
Unknown Facility
Berlin, 12200, Germany
Unknown Facility
Essen, 45122, Germany
Unknown Facility
Debrecen, 4032, Hungary
Unknown Facility
Győr, 9024, Hungary
Unknown Facility
Szolnok, 5004, Hungary
Unknown Facility
Udine, Friuli Venezia Giulia, 33100, Italy
Unknown Facility
Milan, Lombardy, 20133, Italy
Unknown Facility
Milan, Lombardy, 20162, Italy
Unknown Facility
Orbassano, Piedmont, 10043, Italy
Unknown Facility
Turin, Piedmont, 10126, Italy
Unknown Facility
Brasov, 500019, Romania
Unknown Facility
Cluj-Napoca, 400015, Romania
Unknown Facility
Cluj-Napoca, 400058, Romania
Unknown Facility
Timișoara, 300239, Romania
Unknown Facility
Barcelona, Barcelona, 08035, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Madrid, Madrid, 28050, Spain
Unknown Facility
Salamanca, Salamanca, 37007, Spain
Unknown Facility
Valencia, Valencia, 46010, Spain
Unknown Facility
Coventry, CV2 2DX, United Kingdom
Unknown Facility
Glasgow, G12 0YN, United Kingdom
Unknown Facility
London, SW3 6JJ, United Kingdom
Unknown Facility
Sutton, SM2 5PT, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Genentech, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2012
First Posted
April 13, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 2, 2016
Record last verified: 2016-11