PARTNER: Panitumumab Added to Regimen for Treatment of head aNd neck Cancer Evaluation of Response
Study Details
This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.
Protocol Summary
Progression Free Survival (PFS) during the first-line treatment phase
Timeframe: Until withdrawal of full consent or approximately 24 months after the last subject is randomized, whichever occurs first.
Overall Response Rate (ORR), rate of disease control, duration of response, time to response, overal survival separately for first-line and second-line treatment phases
Timeframe: Until withdrawal of full consent or approximately 24 months after the last subject is randomized, whichever occurs first.