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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01577173
First received: April 11, 2012
Last updated: August 25, 2014
Last verified: August 2014

April 11, 2012
August 25, 2014
July 2012
August 2014   (final data collection date for primary outcome measure)
Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01577173 on ClinicalTrials.gov Archive Site
  • Objective response: complete response or partial response [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Disease control: complete response, partial response or stable disease [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Immunogenicity: anti-MEHD7945A levels [ Time Frame: Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
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 safet y of MEHD7945A versus cetuximab in patients with recurrent/metastatic squamous c ell carcinoma of the head and neck who have progressed during or following plati num-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 cro ss-over to MEHD7945A (Arm A) upon central confirmation of progressive disease an d upon meeting eligibility criteria. Anticipated time on study treatment is unti l disease progression or intolerable toxicity occurs.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Head and Neck Cancer
  • Drug: MEHD7945A
    1100 mg iv every 2 weeks
  • Drug: cetuximab
    400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
  • Experimental: A: MEHD7945A
    Intervention: Drug: MEHD7945A
  • Active Comparator: B: Cetuximab
    Intervention: Drug: cetuximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
February 2015
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Reference Study ID Number: GO28076 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States,   Australia,   Belgium,   Bulgaria,   France,   Germany,   Hungary,   Italy,   Romania,   Spain,   United Kingdom
 
NCT01577173
GO28076, 2011-005539-22
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP