Statistical analyses
DLTs, neutropenia, fever, toxicity, thrombocytopenia, anemia
THROMBOCYTOPENIA, NEUTROPENIA, ANEMIA
For the primary objective of defining a safe dose of sorafenib in combination with riluzole, a standard 3+3 approach was used, with 4 dose levels used as described above. The MTD was defined as the first dose level at which exactly 2/6 patients experienced a DLT, or at which 1/6 experienced a DLT and (due to de-escalation) at least 2/3 or 3/6 patients treated with the next higher dose level had a DLT. Once the MTD was identified, enrollment of 12 patients at the recommended safe dose was planned. Patients were monitored for DLTs during the first cycle (28 days) of treatment. A DLT was defined as any significant grade 3 or 4 non-hematological toxicity, grade 4 neutropenia that persisted >5 days or was associated with fever, or grade 4 anemia or thrombocytopenia that occurred during the first cycle of treatment and was attributed to the study treatment.Descriptive statistics were used for the analysis of study parameters, endpoints, and data including patient characteristics and toxicity data. In analyzing the significance of the effect of increasing sorafenib doses on riluzole PK, ANOVA analysis at 0.05 level was used. Student 