1. The Nadella study was performed in a group of patients with solid tumor malignancies that were refractory to conventional therapy or for whom no effective therapy existed. ECOG performance status (PS) was 1 or 2 in 5/17 (30%) patients, 10/17 patients had received 2 or more lines of previous chemotherapy, and 7/17 patients had received previous radiotherapy. Based on data from previous treatment of head and neck cancer patients at the University of Michigan, the patient population to be enrolled in this trial is expected to be 60% PS 0 and 40% PS 1, and some will have received prior chemotherapy and/or radiotherapy. Like the Nadella patient population, a majority of our patients have been pretreated and are of poorer health.