Statistical analyses
tumor, SD
DISEASE, TUMOR
Overall objective tumor response (ORR) per RECIST criteria was summarized for the intention-to-treat (ITT) analysis set comprising all enrolled patients who received study drug dose (partial or complete, n=12).ORR response was defined as the percentage of patients experiencing a complete response or a partial response (RECIST). Clinical benefit (disease control) was defined as CR/PR or stable disease (SD). Unevaluable patients were counted as well as non- responders.Two-sided 95% confidence intervals for categorical variables were derived according to Clopper-Pearson formula.