Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer
Table 1
Phase I dose escalation.
Cohort
Tv g/day
Dose escalation timing (using escalation decision rule in next box)
1
3
Starting dose (dose used in clinical practice)
2
6
Begin after a minimum of 3 subjects in group 1 who have completed 2 weeks of product with no dose limiting toxicity (DLT—defined as any treatment related toxicity > grade 1)
3
9
Begin after a minimum of 3 subjects in group 2 who have completed 2 weeks of product with no DLT