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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01577173
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Drug: MEHD7945A Drug: cetuximab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 24 months ]

Secondary Outcome Measures :
  1. Objective response: complete response or partial response [ Time Frame: approximately 24 months ]
  2. Disease control: complete response, partial response or stable disease [ Time Frame: approximately 24 months ]
  3. Duration of objective response [ Time Frame: approximately 24 months ]
  4. Time to disease progression [ Time Frame: approximately 24 months ]
  5. Overall survival [ Time Frame: approximately 24 months ]
  6. Safety: Incidence of adverse events [ Time Frame: approximately 24 months ]
  7. 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 ]
  8. Immunogenicity: anti-MEHD7945A levels [ Time Frame: Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01577173

  Show 51 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT01577173     History of Changes
Other Study ID Numbers: GO28076
2011-005539-22 ( EudraCT Number )
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Immunoglobulin G
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs