Table 1. Phase 1b study dose cohorts (n... | American Society of Hematology

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

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.