A Study of MEHD7945A Versus Cetuximab in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of The Head And Neck
Status:
Completed
Trial end date:
2015-06-01
Target enrollment:
Participant gender:
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.