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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01577173




Registration number
NCT01577173
Ethics application status
Date submitted
11/04/2012
Date registered
13/04/2012
Date last updated
2/11/2016

Titles & IDs
Public title
A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
Scientific 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
Secondary ID [1] 0 0
2011-005539-22
Secondary ID [2] 0 0
GO28076
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head and Neck Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MEHD7945A
Treatment: Drugs - cetuximab

Experimental: A: MEHD7945A -

Active Comparator: B: Cetuximab -


Treatment: Drugs: MEHD7945A
1100 mg iv every 2 weeks

Treatment: Drugs: cetuximab
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (tumor assessments according to RECIST criteria)
Timepoint [1] 0 0
approximately 24 months
Secondary outcome [1] 0 0
Objective response: complete response or partial response
Timepoint [1] 0 0
approximately 24 months
Secondary outcome [2] 0 0
Disease control: complete response, partial response or stable disease
Timepoint [2] 0 0
approximately 24 months
Secondary outcome [3] 0 0
Duration of objective response
Timepoint [3] 0 0
approximately 24 months
Secondary outcome [4] 0 0
Time to disease progression
Timepoint [4] 0 0
approximately 24 months
Secondary outcome [5] 0 0
Overall survival
Timepoint [5] 0 0
approximately 24 months
Secondary outcome [6] 0 0
Safety: Incidence of adverse events
Timepoint [6] 0 0
approximately 24 months
Secondary outcome [7] 0 0
Pharmacokinetics: Cmax/Cmin
Timepoint [7] 0 0
Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion
Secondary outcome [8] 0 0
Immunogenicity: anti-MEHD7945A levels
Timepoint [8] 0 0
Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
122
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Waratah
Recruitment hospital [3] 0 0
- Wollongong
Recruitment hospital [4] 0 0
- Brisbane
Recruitment hospital [5] 0 0
- Kurralta Park
Recruitment hospital [6] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3002 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
South Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Wisconsin
Country [14] 0 0
Belgium
State/province [14] 0 0
Edegem
Country [15] 0 0
Belgium
State/province [15] 0 0
Namur
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Pleven
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Ruse
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Sofia
Country [19] 0 0
France
State/province [19] 0 0
Clichy
Country [20] 0 0
France
State/province [20] 0 0
Lyon
Country [21] 0 0
France
State/province [21] 0 0
Villejuif
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Essen
Country [24] 0 0
Hungary
State/province [24] 0 0
Debrecen
Country [25] 0 0
Hungary
State/province [25] 0 0
Gyor
Country [26] 0 0
Hungary
State/province [26] 0 0
Szolnok
Country [27] 0 0
Italy
State/province [27] 0 0
Friuli-Venezia Giulia
Country [28] 0 0
Italy
State/province [28] 0 0
Lombardia
Country [29] 0 0
Italy
State/province [29] 0 0
Piemonte
Country [30] 0 0
Romania
State/province [30] 0 0
Brasov
Country [31] 0 0
Romania
State/province [31] 0 0
Cluj-Napoca
Country [32] 0 0
Romania
State/province [32] 0 0
Timisoara
Country [33] 0 0
Spain
State/province [33] 0 0
Barcelona
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Spain
State/province [35] 0 0
Salamanca
Country [36] 0 0
Spain
State/province [36] 0 0
Valencia
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Coventry
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Glasgow
Country [39] 0 0
United Kingdom
State/province [39] 0 0
London
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01577173
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01577173