Table 2.
Treatment information by dose level of idasanutlin
| 100 mg (n = 6) | 150 mg (n = 6) | Total (N = 12) | |
|---|---|---|---|
| Median n of cycles (range) | 9 (7-14) | 13.0 (5-20) | 10.5 (5-20) |
| Median duration on study (range), wk | 36.7 (29.0-131.1) | 77.6 (23.1-105.0) | 54.2 (23.1-131.1) |
| DLT, n* | 0 | 0 | 0 |
| N of patients with treatment holiday, n of cycles | |||
| 1 | 0 | 1 | 1 |
| 2-3 | 1 | 3 | 4 |
| >3 | 1 | — | 1 |
| N of patients continuing on part A (cycle 7+) | 3 | 4 | 7 |
| N of patients eligible for and receiving treatment on part B | 3 | 1 | 4 |
| Pegylated IFN-α2a (part B) | (n = 3) | (n = 1) | (n = 4) |
| Median n of cycles (range) | 2.5 (2-3) | 15 | 3 (2-15) |
| Reason for discontinuation of treatment | |||
| Patient refusal | 2 | 2 | 4 |
| Investigator decision | 2 | 1 | 3 |
*
DLT defined as nonhematologic AE of grade 3+ or hematologic AE of grade 2+ thrombocytopenia or grade 3+ neutropenia or anemia during cycle 1 and evaluated for 56 d.