NCT01577173

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	MEHD7945A	1100 mg iv every 2 weeks
DRUG	cetuximab	400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-04-13
• Last updated: 2016-11-02

Locations

51 sites across 11 countries: United States, Australia, Belgium, Bulgaria, France, Germany, Hungary, Italy, Romania, Spain, United Kingdom