Head and Neck CancerPhase 2NCT01577173
A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
A Phase 2 study testing MEHD7945A and cetuximab in people with Head and Neck Cancer, run by Genentech, Inc. at 51 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- MEHD7945A and cetuximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 51 sitesin 11 countries
- Study dates
- Jul 2012to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Measurable disease per RECIST v1.1
- ECOG performance status of 0, 1 or 2
- Adequate hematologic, renal and liver function
Who cannot join
- 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
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- 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
Trial locations and contacts
51 sites in 11 countries.
51 sites in 11 countries
United States14 sites
Study site
Aurora, Colorado, 80045
Study site
Baltimore, Maryland, 21204
Study site
Boston, Massachusetts, 02114
Study site
Boston, Massachusetts, 02215
Study site
Chapel Hill, North Carolina, 27599-7295
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60637
Study site
Knoxville, Tennessee, 37909
Study site
Madison, Wisconsin, 53705-2275
Study site
Miami, Florida, 33176
Study site
New York, New York, 10011
Study site
Paducah, Kentucky, 42003
Study site
Saint Joseph, Missouri, 64507
Study site
Stanford, California, 94305
Australia6 sites
Study site
Brisbane, Queensland, 4029
Study site
Darlinghurst, New South Wales, 2010
Study site
Kurralta Park, South Australia, 5037
Study site
Melbourne, Victoria, 3002
Study site
Waratah, New South Wales, 2298
Study site
Wollongong, New South Wales, 2500
Italy5 sites
Study site
Milan, Lombardy, 20133
Study site
Milan, Lombardy, 20162
Study site
Orbassano, Piedmont, 10043
Study site
Turin, Piedmont, 10126
Study site
Udine, Friuli Venezia Giulia, 33100
Spain5 sites
Study site
Barcelona, Barcelona, 08035
Study site
Madrid, Madrid, 28041
Study site
Madrid, Madrid, 28050
Study site
Salamanca, Salamanca, 37007
Study site
Valencia, Valencia, 46010
Romania4 sites
Study site
Brasov, 500019
Study site
Cluj-Napoca, 400015
Study site
Cluj-Napoca, 400058
Study site
Timișoara, 300239
United Kingdom4 sites
Study site
Coventry, CV2 2DX
Study site
Glasgow, G12 0YN
Study site
London, SW3 6JJ
Study site
Sutton, SM2 5PT
Bulgaria3 sites
Study site
Pleven, 5800
Study site
Rousse, 7000
Study site
Sofia, 1303
France3 sites
Study site
Clichy, 92118
Study site
Lyon, 69373
Study site
Villejuif, 94805
Hungary3 sites
Study site
Debrecen, 4032
Study site
Győr, 9024
Study site
Szolnok, 5004
About this study
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
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.
- Conditions
- Head and Neck Cancer
- Being tested
- MEHD7945A, cetuximab
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEHD7945ADrug
1100 mg iv every 2 weeks
cetuximabDrug
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
| Study group | Role | What they receive |
|---|---|---|
| A: MEHD7945A | Experimental | Not described Receives: Drug: MEHD7945A |
| B: Cetuximab | Active comparator | Not described Receives: Drug: cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (tumor assessments according to RECIST criteria)
Measured: approximately 24 months
Secondary outcomes (8)
Objective response: complete response or partial response
Measured: approximately 24 months
Disease control: complete response, partial response or stable disease
Measured: approximately 24 months
Duration of objective response
Measured: approximately 24 months
Time to disease progression
Measured: approximately 24 months
Overall survival
Measured: approximately 24 months
Safety: Incidence of adverse events
Measured: approximately 24 months
Pharmacokinetics: Cmax/Cmin
Measured: Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion
Immunogenicity: anti-MEHD7945A levels
Measured: Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577173
- Sponsor's protocol ID
- GO28076
- Other IDs
- 2011-005539-22
- Status last verified
- Nov 2016
- First submitted
- 11 Apr 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01577173
- Acronym / sponsor ID
- GO28076
- Conditions
- Head and Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: MEHD7945A | Experimental | Drug: MEHD7945A |
| B: Cetuximab | Active comparator | Drug: cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEHD7945A1100 mg iv every 2 weeks | Drug | A: MEHD7945A |
| cetuximab400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly | Drug | B: Cetuximab |
Primary outcome
Progression-free survival (tumor assessments according to RECIST criteria)
Time frame: approximately 24 months
8 secondary outcomes
Objective response: complete response or partial response
Time frame: approximately 24 months
Disease control: complete response, partial response or stable disease
Time frame: approximately 24 months
Duration of objective response
Time frame: approximately 24 months
Time to disease progression
Time frame: approximately 24 months
Overall survival
Time frame: approximately 24 months
Safety: Incidence of adverse events
Time frame: approximately 24 months
Pharmacokinetics: Cmax/Cmin
Time frame: Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion
Immunogenicity: anti-MEHD7945A levels
Time frame: Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Genentech, Inc.
51 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEHD7945A and cetuximab in people with Head and Neck Cancer, run by Genentech, Inc. at 51 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Australia, Italy, Spain, Romania and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (tumor assessments according to RECIST criteria) (time frame: approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.