Dose Levels
fatigue, nausea, vomiting
The first 6 patients were treated at 50 mg twice daily. We then escalated to 100 mg twice daily and treated 3 more patients. We then escalated to 200 mg twice daily but found this dose level to be poorly tolerated in all 3 patients due to nausea, vomiting, and fatigue. We then accrued 4 patients at an intermediate dose of 150 mg twice daily. This dose level was also found to be poorly tolerated. On the basis of this, we settled on 100 mg twice daily as the dose for the dose-expansion phase and accrued 2 patients in the expansion cohort at 100 mg twice daily before the COVID-19 pandemic forced us to halt accrual.