A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck

November 1, 2016 updated by: Genentech, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
      • Waratah, New South Wales, Australia, 2298
      • Wollongong, New South Wales, Australia, 2500
    • Queensland
      • Brisbane, Queensland, Australia, 4029
    • South Australia
      • Kurralta Park, South Australia, Australia, 5037
    • Victoria
      • Melbourne, Victoria, Australia, 3002
  • Belgium
      • Edegem, Belgium, 2650
      • Namur, Belgium, 5000
  • Bulgaria
      • Pleven, Bulgaria, 5800
      • Ruse, Bulgaria, 7000
      • Sofia, Bulgaria, 1303
  • France
      • Clichy, France, 92118
      • Lyon, France, 69373
      • Villejuif, France, 94805
  • Germany
      • Berlin, Germany, 12200
      • Essen, Germany, 45122
  • Hungary
      • Debrecen, Hungary, 4032
      • Gyor, Hungary, 9024
      • Szolnok, Hungary, 5004
  • Italy
    • Friuli-Venezia Giulia
      • Udine, Friuli-Venezia Giulia, Italy, 33100
    • Lombardia
      • Milano, Lombardia, Italy, 20133
      • Milano, Lombardia, Italy, 20162
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
      • Torino, Piemonte, Italy, 10126
  • Romania
      • Brasov, Romania, 500019
      • Cluj-Napoca, Romania, 400058
      • Cluj-Napoca, Romania, 400015
      • Timisoara, Romania, 300239
  • Spain
      • Barcelona, Spain, 08035
      • Madrid, Spain, 28041
      • Madrid, Spain, 28050
      • Salamanca, Spain, 37007
      • Valencia, Spain, 46010
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
      • Glasgow, United Kingdom, G12 0YN
      • London, United Kingdom, SW3 6JJ
      • Sutton, United Kingdom, SM2 5PT
  • United States
    • California
      • Stanford, California, United States, 94305
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Miami, Florida, United States, 33176
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Kentucky
      • Paducah, Kentucky, United States, 42003
    • Maryland
      • Baltimore, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02114
    • Missouri
      • St Joseph, Missouri, United States, 64507
    • New York
      • New York, New York, United States, 10011
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7295
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2275

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A: MEHD7945A
Drug: MEHD7945A
1100 mg iv every 2 weeks
Active Comparator: B: Cetuximab
Drug: cetuximab
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival (tumor assessments according to RECIST criteria)
Time Frame: approximately 24 months
approximately 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: approximately 24 months
approximately 24 months
Objective response: complete response or partial response
Time Frame: approximately 24 months
approximately 24 months
Disease control: complete response, partial response or stable disease
Time Frame: approximately 24 months
approximately 24 months
Duration of objective response
Time Frame: approximately 24 months
approximately 24 months
Time to disease progression
Time Frame: approximately 24 months
approximately 24 months
Overall survival
Time Frame: approximately 24 months
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
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
Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GO28076
  • 2011-005539-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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