Baseline characteristics of AML study population
| . | Part A (N = 54) . | Part B (N = 26) . | Part C (N = 14) . | Part D (N = 21) . | Part E (N = 3) . | Overall (N = 118) . |
|---|---|---|---|---|---|---|
| ECOG performance status, n (%)16 | ||||||
| 0 | 4 (7.4) | 1 (3.8) | 1 (7.1) | 3 (14.3) | 2 (66.7) | 11 (9.3) |
| 1 | 34 (63.0) | 19 (73.1) | 11 (78.6) | 13 (61.9) | 0 | 77 (65.3) |
| 2 | 16 (29.6) | 6 (23.1) | 2 (14.3) | 5 (23.8) | 1 (33.3) | 30 (25.4) |
| >2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age at initial diagnosis, y | ||||||
| Median (min, max) | 60.3 (20, 84) | 67.7 (18, 75) | 62.5 (46, 83) | 67.8 (28, 84) | 74.3 (61, 77) | 63.6 (18, 84) |
| Time since initial diagnosis, mo | ||||||
| Median (min, max) | 13.03 (2.2, 206.2) | 8.34 (0.7, 46.4) | 8.31 (3.0, 58.3) | 12.58 (1.3, 44.8) | 10.81 (0.9, 16.6) | 10.76 (0.7, 206.2) |
| Bone marrow aspirate blast count (%) at baseline | ||||||
| Median (min, max) | 46.00 (4.0, 95.0) | 33.00 (1.8, 91.0) | 50.00 (8.0, 84.0) | 24.00 (6.0, 91.0) | 21.00 (16.0, 26.0) | 35.00 (1.8, 95.0) |
| Not reported | 1 (1.9) | 3 (11.5) | 3 (21.4) | 1 (4.8) | 1 (33.3) | 9 (7.6) |
| Bone marrow core blast count, %, at baseline | ||||||
| Median (min, max) | 46.00 (7.5, 90.0) | 38.50 (5.0, 91.0) | 43.00 (10.0, 80.0) | 30.00 (5.0, 90.0) | 25.00 (16.0, 30.0) | 34.00 (5.0, 91.0) |
| Not reported | 38 (70.4) | 12 (46.2) | 2 (14.3) | 4 (19.0) | 0 | 56 (47.5) |
| Therapy-related AML, n (%) | ||||||
| Yes | 4 (7.4) | 5 (19.2) | 2 (14.3) | 4 (19.0) | 0 | 15 (12.7) |
| No | 48 (88.9) | 21 (80.8) | 12 (85.7) | 17 (81.0) | 3 (100.0) | 101 (85.6) |
| Unknown | 2 (3.7) | 0 | 0 | 0 | 0 | 2 (1.7) |
| Disease status at last assessment before study start, n (%) | ||||||
| Primary induction failure | 16 (29.6) | 10 (38.5) | 2 (14.3) | 4 (19.0) | 1 (33.3) | 33 (28.0) |
| First relapse | 23 (42.6) | 10 (38.5) | 7 (50.0) | 8 (38.1) | 1 (33.3) | 49 (41.5) |
| Second relapse | 11 (20.4) | 4 (15.4) | 4 (28.6) | 7 (33.3) | 1 (33.3) | 27 (22.9) |
| Third relapse | 1 (1.9) | 2 (7.7) | 0 | 0 | 0 | 3 (2.5) |
| Fourth or more relapse | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (0.8) |
| Unspecified | 3 (5.6) | 0 | 1 (7.1) | 1 (4.8) | 0 | 5 (4.2) |
| AML, number of previous systemic therapies | ||||||
| Median | 3.00 | 2.00 | 3.00 | 3.00 | 1.00 | 3.00 |
| . | Part A (N = 54) . | Part B (N = 26) . | Part C (N = 14) . | Part D (N = 21) . | Part E (N = 3) . | Overall (N = 118) . |
|---|---|---|---|---|---|---|
| ECOG performance status, n (%)16 | ||||||
| 0 | 4 (7.4) | 1 (3.8) | 1 (7.1) | 3 (14.3) | 2 (66.7) | 11 (9.3) |
| 1 | 34 (63.0) | 19 (73.1) | 11 (78.6) | 13 (61.9) | 0 | 77 (65.3) |
| 2 | 16 (29.6) | 6 (23.1) | 2 (14.3) | 5 (23.8) | 1 (33.3) | 30 (25.4) |
| >2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age at initial diagnosis, y | ||||||
| Median (min, max) | 60.3 (20, 84) | 67.7 (18, 75) | 62.5 (46, 83) | 67.8 (28, 84) | 74.3 (61, 77) | 63.6 (18, 84) |
| Time since initial diagnosis, mo | ||||||
| Median (min, max) | 13.03 (2.2, 206.2) | 8.34 (0.7, 46.4) | 8.31 (3.0, 58.3) | 12.58 (1.3, 44.8) | 10.81 (0.9, 16.6) | 10.76 (0.7, 206.2) |
| Bone marrow aspirate blast count (%) at baseline | ||||||
| Median (min, max) | 46.00 (4.0, 95.0) | 33.00 (1.8, 91.0) | 50.00 (8.0, 84.0) | 24.00 (6.0, 91.0) | 21.00 (16.0, 26.0) | 35.00 (1.8, 95.0) |
| Not reported | 1 (1.9) | 3 (11.5) | 3 (21.4) | 1 (4.8) | 1 (33.3) | 9 (7.6) |
| Bone marrow core blast count, %, at baseline | ||||||
| Median (min, max) | 46.00 (7.5, 90.0) | 38.50 (5.0, 91.0) | 43.00 (10.0, 80.0) | 30.00 (5.0, 90.0) | 25.00 (16.0, 30.0) | 34.00 (5.0, 91.0) |
| Not reported | 38 (70.4) | 12 (46.2) | 2 (14.3) | 4 (19.0) | 0 | 56 (47.5) |
| Therapy-related AML, n (%) | ||||||
| Yes | 4 (7.4) | 5 (19.2) | 2 (14.3) | 4 (19.0) | 0 | 15 (12.7) |
| No | 48 (88.9) | 21 (80.8) | 12 (85.7) | 17 (81.0) | 3 (100.0) | 101 (85.6) |
| Unknown | 2 (3.7) | 0 | 0 | 0 | 0 | 2 (1.7) |
| Disease status at last assessment before study start, n (%) | ||||||
| Primary induction failure | 16 (29.6) | 10 (38.5) | 2 (14.3) | 4 (19.0) | 1 (33.3) | 33 (28.0) |
| First relapse | 23 (42.6) | 10 (38.5) | 7 (50.0) | 8 (38.1) | 1 (33.3) | 49 (41.5) |
| Second relapse | 11 (20.4) | 4 (15.4) | 4 (28.6) | 7 (33.3) | 1 (33.3) | 27 (22.9) |
| Third relapse | 1 (1.9) | 2 (7.7) | 0 | 0 | 0 | 3 (2.5) |
| Fourth or more relapse | 0 | 0 | 0 | 1 (4.8) | 0 | 1 (0.8) |
| Unspecified | 3 (5.6) | 0 | 1 (7.1) | 1 (4.8) | 0 | 5 (4.2) |
| AML, number of previous systemic therapies | ||||||
| Median | 3.00 | 2.00 | 3.00 | 3.00 | 1.00 | 3.00 |
ECOG, Eastern Cooperative Oncology Group performance status; max, maximum; min, minimum.
Baseline is defined as the last nonmissing result before administration of the first dose.