Table 2 Summary of cohorts and dose escalation based on dose-limiting toxicity
Part | Selumetinib dose | n (evaluable for dose escalation) | Evaluable patients with a DLT | DLT information | |
|---|---|---|---|---|---|
Selumetinib in combination with docetaxel | |||||
A | 50 mg BID | 7 (6) | 0 | NA | |
75 mg BID with ppG-CSF | 7 (6) | 0 | NA | ||
75 mg BID without ppG-CSF | 8 (5) | 2 | Grade 4 neutropenia with fever (n = 1) Grade 4 thrombocytopenia (n = 1) | ||
B | 75 mg BID with ppG-CSF | 12 (NA) | NA | NA | |
75 mg BID without ppG-CSF | 1 (NA) | NA | NA | ||
Selumetinib in combination with dacarbazine | |||||
A | 50 mg BID | 7 (6) | 1 | Grade 4 thrombocytopenia (n = 1) | |
75 mg BID | 6 (6) | 0 | NA | ||
B | 75 mg BID | 12 (NA) | NA | NA | |