Table 1.
Phase 1b study dose cohorts (n = 25)
| Cohort | n | Nanatinostat dose | VGCV dose | Responses | DLTs |
|---|---|---|---|---|---|
| 1 | 7∗ | 10 mg BID | 900 mg BID1 (n = 4) 450 mg BID2 (n = 3) |
2 CR, 1 PR |
G4 neutropenia (n = 1) G4 thrombocytopenia (n = 1) G3 thrombocytopenia (n = 2) |
| 2a | 5† | 5 mg BID | 450 mg BID | 1 CR, 1 PR |
No DLT |
| 2b | 4∗ | 10 mg QD | 450 mg BID | 1 CR, 1 PR |
No DLT |
| 2c | 4 | 10 mg QD | 900 mg QD | – | No DLT |
| 3‡ | 5 | 20 mg QD 4 days on/3 days off schedule |
900 mg QD | 1 CR, 2 PR |
No DLT |
BID, twice daily; G, grade.
One patient not evaluable.
Two patients not evaluable.
This regimen chosen as the RP2D; nanatinostat given on days 1 to 4, 8 to 11, 15 to 18, and 22 to 25 of each cycle.