Clinical trial NCT01577173: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-13
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Progression-free survival (tumor assessments according to RECIST criteria)
timeFrame: approximately 24 months
Secondary outcomes:
measure: Objective response: complete response or partial response
timeFrame: approximately 24 months
measure: Disease control: complete response, partial response or stable disease
timeFrame: approximately 24 months
measure: Duration of objective response
timeFrame: approximately 24 months
measure: Time to disease progression
timeFrame: approximately 24 months
measure: Overall survival
timeFrame: approximately 24 months
measure: Safety: Incidence of adverse events
timeFrame: approximately 24 months
measure: Pharmacokinetics: Cmax/Cmin
timeFrame: Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion
measure: Immunogenicity: anti-MEHD7945A levels
timeFrame: Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion
Other outcomes:
Locations:
city: Stanford
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Paducah
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: St Joseph
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charleston
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Madison
country: United States
state: Wisconsin
city: Darlinghurst
country: Australia
state: New South Wales
city: Waratah
country: Australia
state: New South Wales
city: Wollongong
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Kurralta Park
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Edegem
country: Belgium
city: Namur
country: Belgium
city: Pleven
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Clichy
country: France
city: Lyon
country: France
city: Villejuif
country: France
city: Berlin
country: Germany
city: Essen
country: Germany
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Szolnok
country: Hungary
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Orbassano
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Brasov
country: Romania
city: Cluj-Napoca
country: Romania
city: Cluj-Napoca
country: Romania
city: Timisoara
country: Romania
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Valencia
country: Spain
city: Coventry
country: United Kingdom
city: Glasgow
country: United Kingdom
city: London
country: United Kingdom
city: Sutton
country: United Kingdom
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: