Statistical Analysis: No formal inferential statistical analyses will be performed. Data will be summarized using descriptive statistics (number of patients, mean, median, standard deviation, minimum, and maximum) for continuous variables and using frequency and percentage for discrete variables. For the safety analyses, data will be presented for all patients. An accounting of the study patients by disposition will be tabulated. Demographic data (e.g., age, gender), medical history, cancer history, and other baseline characteristics will be summarized.