Baseline patient demographics and characteristics, and barasertib treatment cycles
| . | Barasertib dose . | |||||||
|---|---|---|---|---|---|---|---|---|
| Part A . | Part B . | |||||||
| 50 mg (n = 3) . | 100 mg (n = 3) . | 200 mg (n = 3) . | 400 mg (n = 4) . | 800 mg (n = 7) . | 1200 mg (n = 6) . | 1600 mg (n = 6) . | 1200 mg (n = 32) . | |
| Median age, y (range) | 66.0 (46-75) | 73.0 (65-82) | 60.0 (56-62) | 67.5 (66-80) | 64.0 (59-74) | 68.0 (45-75) | 65.0 (57-76) | 69.0 (48-87) |
| Male sex, n (%) | 2 (67) | 2 (67) | 1 (33) | 3 (75) | 5 (71) | 3 (50) | 2 (33) | 19 (59) |
| WHO performance status, n (%) | ||||||||
| 0 | 0 | 3 (100) | 1 (33) | 3 (75) | 4 (57) | 2 (33) | 3 (50) | 16 (50) |
| 1 | 2 (67) | 0 | 1 (33) | 1 (25) | 2 (29) | 3 (50) | 1 (17) | 13 (41) |
| 2 | 1 (33) | 0 | 1 (33) | 0 | 1 (14) | 1 (17) | 2 (33) | 3 (9) |
| AML type, n (%) | ||||||||
| De novo | 1 (33) | 2 (67) | 1 (33) | 0 | 6 (86) | 2 (33) | 3 (50) | 10 (31) |
| Secondary to myelodysplastic syndrome or myeloproliferative disorder | 2 (67) | 1 (33) | 2 (67) | 3 (75) | 0 | 2 (33) | 3 (50) | 12 (37) |
| Secondary to chemotherapy | 0 | 0 | 0 | 1 (25) | 1 (14) | 1 (17) | 0 | 4 (13) |
| Other* | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 6 (19) |
| AML status, n (%) | ||||||||
| Newly diagnosed | 0 | 0 | 0 | 1 (25) | 0 | 2 (33) | 1 (17) | 15 (47) |
| First relapse | 3 (100) | 3 (100) | 3 (100) | 2 (50) | 6 (86) | 4 (67) | 4 (67) | 12 (38) |
| Second relapse | 0 | 0 | 0 | 1 (25) | 0 | 0 | 0 | 3 (9) |
| Missing | 0 | 0 | 0 | 0 | 1 (14) | 0 | 1 (17) | 2 (6) |
| Time to relapse for patients in first relapse, n (%)† | ||||||||
| <6 months | 1 (33) | 0 | 1 (33) | 0 | 0 | 1 (17) | 0 | 1 (3) |
| 6 to < 12 months | 2 (67) | 1 (33) | 1 (33) | 0 | 0 | 0 | 0 | 2 (6) |
| ≥12 months | 0 | 1 (33) | 0 | 2 (50) | 0 | 0 | 1 (17) | 0 |
| Missing | 0 | 1 (33) | 1 (33) | 0 | 6 (86) | 3 (50) | 3 (50) | 9 (28) |
| Cytogenetic information, n (%) | ||||||||
| Normal | 2 (67) | 0 | 2 (67) | 1 (25) | 2 (29) | 0 | 1 (17) | 8 (25) |
| Complex (>3 abnormalities) | 1 (33) | 0 | 0 | 0 | 0 | 4 (67) | 0 | 1 (3) |
| Abnormalities of 5 and/or 7 | 0 | 0 | 1 (33) | 1 (25) | 0 | 1 (17) | 1 (17) | 3 (9) |
| Other | 0 | 1 (33) | 0 | 1 (25) | 3 (43) | 0 | 2 (33) | 9 (28) |
| Not available | 0 | 2 (67) | 0 | 1 (25) | 2 (29) | 1 (17) | 2 (33) | 11 (34) |
| Number of prior chemotherapy regimens, n (%) | ||||||||
| 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 2 (6) |
| 1 | 0 | 1 (33) | 0 | 0 | 1 (14) | 0 | 2 (33) | 5 (16) |
| 2 | 0 | 0 | 0 | 2 (50) | 3 (43) | 1 (17) | 1 (17) | 13 (41) |
| ≥3 | 3 (100) | 2 (67) | 3 (100) | 2 (50) | 3 (43) | 4 (67) | 3 (50) | 12 (38) |
| Prior radiotherapy, n (%) | ||||||||
| No | 3 (100) | 3 (100) | 3 (100) | 3 (75) | 7 (100) | 6 (100) | 5 (83) | 29 (91) |
| Yes | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (17) | 3 (9) |
| Number of cycles of barasertib received, n (%) | ||||||||
| ≥1 | 3 (100) | 3 (100) | 3 (100) | 4 (100) | 7 (100) | 6 (100) | 6 (100) | 32 (100) |
| ≥2 | 2 (67) | 3 (100) | 1 (33) | 3 (75) | 5 (71) | 2 (33) | 3 (50) | 16 (50) |
| ≥3 | 1 (33) | 2 (67) | 0 | 1 (25) | 3 (43) | 2 (33) | 1 (17) | 8 (25) |
| ≥4 | 0 | 0 | 0 | 0 | 1 (14) | 0 | 0 | 2 (6) |
| ≥5 | 0 | 0 | 0 | 0 | 1 (14) | 0 | 0 | 1 (3) |
| ≥6 | 0 | 0 | 0 | 0 | 1 (14) | 0 | 0 | 1 (3) |
| . | Barasertib dose . | |||||||
|---|---|---|---|---|---|---|---|---|
| Part A . | Part B . | |||||||
| 50 mg (n = 3) . | 100 mg (n = 3) . | 200 mg (n = 3) . | 400 mg (n = 4) . | 800 mg (n = 7) . | 1200 mg (n = 6) . | 1600 mg (n = 6) . | 1200 mg (n = 32) . | |
| Median age, y (range) | 66.0 (46-75) | 73.0 (65-82) | 60.0 (56-62) | 67.5 (66-80) | 64.0 (59-74) | 68.0 (45-75) | 65.0 (57-76) | 69.0 (48-87) |
| Male sex, n (%) | 2 (67) | 2 (67) | 1 (33) | 3 (75) | 5 (71) | 3 (50) | 2 (33) | 19 (59) |
| WHO performance status, n (%) | ||||||||
| 0 | 0 | 3 (100) | 1 (33) | 3 (75) | 4 (57) | 2 (33) | 3 (50) | 16 (50) |
| 1 | 2 (67) | 0 | 1 (33) | 1 (25) | 2 (29) | 3 (50) | 1 (17) | 13 (41) |
| 2 | 1 (33) | 0 | 1 (33) | 0 | 1 (14) | 1 (17) | 2 (33) | 3 (9) |
| AML type, n (%) | ||||||||
| De novo | 1 (33) | 2 (67) | 1 (33) | 0 | 6 (86) | 2 (33) | 3 (50) | 10 (31) |
| Secondary to myelodysplastic syndrome or myeloproliferative disorder | 2 (67) | 1 (33) | 2 (67) | 3 (75) | 0 | 2 (33) | 3 (50) | 12 (37) |
| Secondary to chemotherapy | 0 | 0 | 0 | 1 (25) | 1 (14) | 1 (17) | 0 | 4 (13) |
| Other* | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 6 (19) |
| AML status, n (%) | ||||||||
| Newly diagnosed | 0 | 0 | 0 | 1 (25) | 0 | 2 (33) | 1 (17) | 15 (47) |
| First relapse | 3 (100) | 3 (100) | 3 (100) | 2 (50) | 6 (86) | 4 (67) | 4 (67) | 12 (38) |
| Second relapse | 0 | 0 | 0 | 1 (25) | 0 | 0 | 0 | 3 (9) |
| Missing | 0 | 0 | 0 | 0 | 1 (14) | 0 | 1 (17) | 2 (6) |
| Time to relapse for patients in first relapse, n (%)† | ||||||||
| <6 months | 1 (33) | 0 | 1 (33) | 0 | 0 | 1 (17) | 0 | 1 (3) |
| 6 to < 12 months | 2 (67) | 1 (33) | 1 (33) | 0 | 0 | 0 | 0 | 2 (6) |
| ≥12 months | 0 | 1 (33) | 0 | 2 (50) | 0 | 0 | 1 (17) | 0 |
| Missing | 0 | 1 (33) | 1 (33) | 0 | 6 (86) | 3 (50) | 3 (50) | 9 (28) |
| Cytogenetic information, n (%) | ||||||||
| Normal | 2 (67) | 0 | 2 (67) | 1 (25) | 2 (29) | 0 | 1 (17) | 8 (25) |
| Complex (>3 abnormalities) | 1 (33) | 0 | 0 | 0 | 0 | 4 (67) | 0 | 1 (3) |
| Abnormalities of 5 and/or 7 | 0 | 0 | 1 (33) | 1 (25) | 0 | 1 (17) | 1 (17) | 3 (9) |
| Other | 0 | 1 (33) | 0 | 1 (25) | 3 (43) | 0 | 2 (33) | 9 (28) |
| Not available | 0 | 2 (67) | 0 | 1 (25) | 2 (29) | 1 (17) | 2 (33) | 11 (34) |
| Number of prior chemotherapy regimens, n (%) | ||||||||
| 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 2 (6) |
| 1 | 0 | 1 (33) | 0 | 0 | 1 (14) | 0 | 2 (33) | 5 (16) |
| 2 | 0 | 0 | 0 | 2 (50) | 3 (43) | 1 (17) | 1 (17) | 13 (41) |
| ≥3 | 3 (100) | 2 (67) | 3 (100) | 2 (50) | 3 (43) | 4 (67) | 3 (50) | 12 (38) |
| Prior radiotherapy, n (%) | ||||||||
| No | 3 (100) | 3 (100) | 3 (100) | 3 (75) | 7 (100) | 6 (100) | 5 (83) | 29 (91) |
| Yes | 0 | 0 | 0 | 1 (25) | 0 | 0 | 1 (17) | 3 (9) |
| Number of cycles of barasertib received, n (%) | ||||||||
| ≥1 | 3 (100) | 3 (100) | 3 (100) | 4 (100) | 7 (100) | 6 (100) | 6 (100) | 32 (100) |
| ≥2 | 2 (67) | 3 (100) | 1 (33) | 3 (75) | 5 (71) | 2 (33) | 3 (50) | 16 (50) |
| ≥3 | 1 (33) | 2 (67) | 0 | 1 (25) | 3 (43) | 2 (33) | 1 (17) | 8 (25) |
| ≥4 | 0 | 0 | 0 | 0 | 1 (14) | 0 | 0 | 2 (6) |
| ≥5 | 0 | 0 | 0 | 0 | 1 (14) | 0 | 0 | 1 (3) |
| ≥6 | 0 | 0 | 0 | 0 | 1 (14) | 0 | 0 | 1 (3) |
In part A, other AML type was newly diagnosed AML classified as secondary to chemotherapy, myelodysplastic syndrome, and chronic lymphocytic leukemia for 1 patient in part A; in part B, other AML type includes 4 newly diagnosed patients (1 in first relapse, 2 with chronic myelomonocytic leukemia, and 1 with newly diagnosed AML), 1 patient in first relapse, and 1 patient in second relapse.
Time to first relapse after a CR and before treatment with barasertib.