Study 1 Part 1 (n = 13) | Study 1 Part 2 (n = 3) | Study 2 (n = 5) | Study 3 (n = 1) | |
---|---|---|---|---|
Male/Female, n (%) | 11 (85)/2 (15) | 2 (67)/1 (33) | 3 (60)/2 (40) | 1 (100)/0 |
Mean age, years (SD) | 68.6 (7.7) | N/A | 73.2 (4.6) | 69 (N/A) |
ECOG PS, n (%) | N/A | |||
0 | 4 (31) | 4 (80) | 0 | |
1 | 7 (54) | 1 (20) | 1 (100) | |
2 | 2 (15) | 0 | 0 | |
Disease, n (%) | N/A | |||
MDS | 12 (92) | 5 (100) | 0 | |
CMML | 1 (8) | 0 | 0 | |
AML | 0 | 0 | 1 (100) | |
IPSS classification at screening, n (%) | N/A | |||
Int-2 (1.5–2.0) | 9 (69) | 2 (40) | 0 | |
High (≥ 2.5) | 4 (31) | 3 (60) | 1 (100) | |
Previous treatments, n (%) | N/A | |||
No prior treatment | 11 (85) | 1 (20) | 0 | |
Azacitidine | 0 | 4 (80) | 1 (100) | |
Cytarabine | 0 | 1 (20) | 0 | |
Aclarubicin hydrochloride | 0 | 1 (20) | 0 | |
Growth factor | 1 (8) | 0 | 0 | |
Lenalidomide | 1 (8) | 0 | 0 | |
Other | 2 (15) | 0 | 0 | |
Median BSA, m2 (range) | 1.9 (1.7–2.2) | N/A | 1.6 (1.4–1.8) | 1.7 (N/A) |
Median body weight, kg (range) | 79.9 (64.2–99.2) | N/A | 59.5 (48.0–69.0) | 60.5 (N/A) |