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OpenTrials
Completed

NCT Number: NCT01577173

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MEHD7945A

Drug

1100 mg iv every 2 weeks

Cetuximab

Drug

400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly

Primary outcomes

  1. Progression-free survival (tumor assessments according to RECIST criteria)

    Time frame: approximately 24 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Apr 13, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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