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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577173
• Other study ID #: GO28076
• Secondary ID: 2011-005539-22
• Status: Completed
• Phase: Phase 2
• First received: April 11, 2012
• Last updated: November 1, 2016
• Start date: July 2012
• Est. completion date: June 2015

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• MEHD7945A
1100 mg iv every 2 weeks
• cetuximab
400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  France,  Germany,  Hungary,  Italy,  Romania,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (tumor assessments according to RECIST criteria)		approximately 24 months	No
Secondary	Objective response: complete response or partial response		approximately 24 months	No
Secondary	Disease control: complete response, partial response or stable disease		approximately 24 months	No
Secondary	Duration of objective response		approximately 24 months	No
Secondary	Time to disease progression		approximately 24 months	No
Secondary	Overall survival		approximately 24 months	No
Secondary	Safety: Incidence of adverse events		approximately 24 months	No
Secondary	Pharmacokinetics: Cmax/Cmin		Pre-dose and 30 min after end of infusion on Day 1 of Cycles 1, 2, 3, and 4, and at treatment completion	No
Secondary	Immunogenicity: anti-MEHD7945A levels		Pre-dose on Day 1 of Cycles 1 and 4, and at treatment completion	No