Table 2.
Treatment-emergent adverse events occurring by treatment phase (safety population)*
| ESCAL | ESCAL | ESCAL | ESCAL | ESCAL | EXP | RP2D 300 mg ESCAL+EXP (n = 40) |
Overall ESCAL+EXP (N = 59) |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 100 mg (n = 1) |
150 mg (n = 4) |
200 mg (n = 14) |
300 mg (n = 14) |
Overall (n = 33) |
RP2D 300 mg (n = 26) |
|||||||||||
| Any Grade | Grade 3/4 |
Any Grade | Grade 3/4 |
Any Grade | Grade 3/4 |
Any Grade | Grade 3/4 |
Any Grade | Grade 3/4 |
Any Grade |
Grade 3/4 |
Any Grade |
Grade 3/4 |
Any Grade |
Grade 3/4 |
|
| ≥1 TEAE, n (%) | 1 (100) | 1 (100) | 4 (100) | 4 (100) | 14 (100) | 12 (85.7) | 14 (100) | 10 (71.4) | 33 (100) | 27 (81.8) | 26 (100) | 19 (73.1) | 40 (100) | 29 (72.5) | 59 (100) | 46 (78.0) |
| Gastrointestinal | ||||||||||||||||
| Nausea | 0 | 0 | 2 (50.0) | 0 | 8 (57.1) | 0 | 11 (78.6) | 0 | 21 (63.6) | 0 | 18 (69.2) | 0 | 29 (72.5) | 0 | 39 (66.1) | 0 |
| Constipation | 0 | 0 | 2 (50.0) | 0 | 8 (57.1) | 0 | 9 (64.3) | 0 | 19 (57.6) | 0 | 15 (57.7) | 1 (3.8) | 24 (60.0) | 1 (2.5) | 34 (57.6) | 1 (1.7) |
| Diarrhea | 1 (100) | 0 | 1 (25.0) | 0 | 6 (42.9) | 1 (7.1) | 8 (57.1) | 1 (7.1) | 16 (48.5) | 2 (6.1) | 17 (65.4) | 2 (7.7) | 25 (62.5) | 3 (7.5) | 33 (55.9) | 4 (6.8) |
| Vomiting | 1 (100) | 0 | 0 | 0 | 7 (50.0) | 1 (7.1) | 8 (57.1) | 1 (7.1) | 16 (48.5) | 2 (6.1) | 14 (53.8) | 0 | 22 (55.0) | 1 (2.5) | 30 (50.8) | 2 (3.4) |
| Dyspepsia | 0 | 0 | 1 (25.0) | 0 | 5 (35.7) | 0 | 5 (35.7) | 0 | 11 (33.3) | 0 | 3 (11.5) | 0 | 8 (20.0) | 0 | 14 (23.7) | 0 |
| Stomatitis | 1 (100) | 0 | 1 (25.0) | 0 | 1 (7.1) | 0 | 5 (35.7) | 1 (7.1) | 8 (24.2) | 1 (3.0) | 5 (19.2) | 0 | 10 (25.0) | 1 (2.5) | 13 (22.0) | 1 (1.7) |
| Abdominal pain | 0 | 0 | 2 (50.0) | 0 | 2 (14.3) | 0 | 1 (7.1) | 0 | 5 (15.2) | 0 | 7 (26.9) | 1 (3.8) | 8 (20.0) | 1 (2.5) | 12 (20.3) | 1 (1.7) |
| Hematologic | ||||||||||||||||
| Neutropenia | 1 (100) | 1 (100) | 4 (100) | 4 (100) | 11 (78.6) | 11 (78.6) | 8 (57.1) | 8 (57.1) | 24 (72.7) | 24 (72.7) | 13 (50.0) | 13 (50.0) | 21 (52.5) | 21 (52.5) | 37 (62.7) | 37 (62.7) |
| Febrile neutropenia | 0 | 0 | 2 (50.0) | 2 (50.0) | 4 (28.6) | 4 (28.6) | 2 (14.3) | 2 (14.3) | 8 (24.2) | 8 (24.2) | 7 (26.9) | 7 (26.9) | 9 (22.5) | 9 (22.5) | 15 (25.4) | 15 (25.4) |
| Anemia | 0 | 0 | 2 (50.0) | 2 (50.0) | 2 (14.3) | 2 (14.3) | 2 (14.3) | 1 (7.1) | 6 (18.2) | 5 (15.2) | 7 (26.9) | 5 (19.2) | 9 (22.5) | 6 (15.0) | 13 (22.0) | 10 (16.9) |
| Thrombocytopenia | 0 | 0 | 1 (25.0) | 1 (25.0) | 3 (21.4) | 2 (14.3) | 1 (7.1) | 1 (7.1) | 5 (15.2) | 4 (12.1) | 5 (19.2) | 4 (15.4) | 6 (15.0) | 5 (12.5) | 10 (16.9) | 8 (13.6) |
| Leukopenia | 0 | 0 | 1 (25.0) | 1 (25.0) | 1 (7.1) | 1 (7.1) | 0 | 0 | 2 (6.1) | 2 (6.1) | 1 (3.8) | 1 (3.8) | 1 (2.5) | 1 (2.5) | 3 (5.1) | 3 (5.1) |
| Other | ||||||||||||||||
| Fatigue | 0 | 0 | 3 (75.0) | 0 | 6 (42.9) | 0 | 9 (64.3) | 0 | 18 (54.5) | 0 | 14 (53.8) | 0 | 23 (57.5) | 0 | 32 (54.2) | 0 |
| Alopecia | 1 (100) | 0 | 0 | 0 | 6 (42.9) | 0 | 5 (35.7) | 0 | 12 (36.4) | 0 | 11 (42.3) | 0 | 16 (40.0) | 0 | 23 (39.0) | 0 |
| Decreased appetite | 0 | 0 | 2 (50.0) | 0 | 3 (21.4) | 0 | 4 (28.6) | 0 | 9 (27.3) | 0 | 7 (26.9) | 0 | 11 (27.5) | 0 | 16 (27.1) | 0 |
| Dizziness | 0 | 0 | 0 | 0 | 3 (21.4) | 0 | 4 (28.6) | 0 | 7 (21.2) | 0 | 7 (26.9) | 0 | 11 (27.5) | 0 | 14 (23.7) | 0 |
| Headache | 0 | 0 | 1 (25.0) | 0 | 4 (28.6) | 0 | 5 (35.7) | 0 | 10 (30.3) | 0 | 4 (15.4) | 0 | 9 (22.5) | 0 | 14 (23.7) | 0 |
| Insomnia | 1 (100) | 0 | 0 | 0 | 2 (14.3) | 0 | 5 (35.7) | 0 | 8 (24.2) | 0 | 4 (15.4) | 0 | 9 (22.5) | 0 | 12 (20.3) | 0 |
| Edema peripheral | 1 (100) | 0 | 0 | 0 | 1 (7.1) | 0 | 3 (21.4) | 0 | 5 (15.2) | 0 | 7 (26.9) | 0 | 10 (25.0) | 0 | 12 (20.3) | 0 |
| Pulmonary embolism | 0 | 0 | 0 | 0 | 1 (7.1) | 1 (7.1) | 0 | 0 | 1 (3.0) | 1 (3.0) | 3 (11.5) | 3 (11.5) | 3 (7.5) | 3 (7.5) | 4 (6.8) | 4 (6.8) |
ESCAL, dose-escalation phase; EXP, expansion phase; RP2D, recommended phase 2 dose; TEAE, treatment-emergent adverse event.
*
Events of any grade reported in ≥20% of patients and grade 3/4 events reported in ≥5% of patients are shown.