Table 2.
Dose-limiting toxicity (Grade) | Arm A Daily (n=7) | Arm B Daily (n=7) | Arm C 7d on, 7d off (n=12) | Arm D 5d on, 2d off (n=15) | All Arms§ (n=41) |
||||
---|---|---|---|---|---|---|---|---|---|
250mg n=3 | 300mg n=4 | 300mg n=7 | 250mg n=6 | 300mg n=6 | 250mg n=3 | 300mg n=6 | 350mg n=6 | ||
Maculopapular rash | 1 (G3) | 2 (G3) | 4 (G3) | 0 | 1 (G3) | 0 | 1 (G3) | 1 (G3) | 10 (G3) |
Hyperglycemia | 0 | 0 | 1 (G3) | 0 | 0 | 0 | 0 | 0 | 1 (G3) |
Hypotension | 0 | 0 | 0 | 0 | 1 (G3) | 0 | 0 | 0 | 1 (G3) |
Abdominal pain | 0 | 1 (G3)* | 0 | 0 | 0 | 0 | 0 | 0 | 1 (G3) |
G3 abdominal pain constituted DLT as it warranted hospitalization.
The Arm D expansion cohort (b=10) was not included in the DLT assessment.