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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.
Verified March 2013 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01577173
First received: April 11, 2012
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Head and Neck Cancer
 Drug: MEHD7945A
Drug: cetuximab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Progression-free survival (tumor assessments according to RECIST criteria) [ Time Frame: approximately 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: July 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01577173

Contacts
Contact: Please reference Study ID Number: GO28076 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 51 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01577173     History of Changes
Other Study ID Numbers: GO28076, 2011-005539-22
Study First Received: April 11, 2012
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013