Determination of dose-limiting toxicity
folliculitis
EVENTS, FOLLICULITIS
No DLT events were observed in the 4 mg and 6 mg doses. No DLT events were seen in the first three patients allocated to the 8 mg dose group. All three (100%) patients in the 12 mg dose group presented with folliculitis, therefore more patients were allocated to the expanded 8 mg dose group. One patient from the expansion phase that received the 8 mg dose presented with a DLT, folliculitis. This led to that dose group being expanded. The final proportion of patients presenting with folliculitis was 12.5% 