Table 2.
TEAEs occurring in >10% of patients in total (safety analysis set) by CTCAE grade.
| Patient cohort | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 (N = 2) | Cohort 2 (N = 7) | Cohort 3 (N = 3) | Cohort 4 (N = 3) | Cohort 5 (N = 8) | Cohort 6 (N = 7) | Cohort 7 (N = 6) | ||||||||||
| 20 mg BID ceralasertib 17 days | 20 mg BID ceralasertib 10 days | 40 mg BID ceralasertib 10 days | 40 mg BID ceralasertib 7 days | 60 mg QD ceralasertib 7 days | 60 mg QD codosing ceralasertib 3 days | 40 mg QD codosing ceralasertib 2 days | ||||||||||
| Not tolerated | Tolerated | Not tolerated | Not tolerated | Not tolerated | Not tolerated | Tolerated | Total (N = 36) | |||||||||
| Preferred term | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 | Grade 1–2 | Grade ≥3 |
| Any AE | 1 (50) | 1 (50) | 2 (29) | 5 (71) | 1 (33) | 2 (67) | 0 | 3 (100) | 4 (50) | 4 (50) | 0 | 7 (100) | 1 (17) | 5 (83) | 9 (25) | 27 (75) |
| Thrombocytopenia | 1 (50) | 1 (50) | 4 (58) | 1 (14) | 1 (33) | 2 (67) | 0 | 3 (100) | 4 (50) | 2 (25) | 2 (29) | 4 (57) | 0 | 0 | 12 (33) | 13 (36) |
| Anemia | 1 (50) | 0 | 2 (29) | 2 (29) | 1 (33) | 0 | 1 (33) | 1 (33) | 3 (38) | 3 (38) | 2 (29) | 4 (57) | 1 (17) | 4 (67) | 11 (31) | 14 (39) |
| Nausea | 1 (50) | 0 | 2 (29) | 0 | 0 | 0 | 2 (67) | 0 | 4 (50) | 0 | 6 (86) | 1 (14) | 5 (83) | 0 | 20 (56) | 1 (3) |
| Fatigue | 2 (100) | 0 | 4 (58) | 1 (14) | 1 (33) | 0 | 1 (33) | 0 | 3 (38) | 0 | 1 (14) | 0 | 4 (67) | 0 | 16 (44) | 1 (3) |
| Neutropenia | 0 | 1 (50) | 1 (14) | 0 | 1 (33) | 2 (67) | 1 (33) | 1 (33) | 0 | 0 | 1 (14) | 5 (71) | 0 | 0 | 4 (11) | 9 (25) |
| Constipation | 1 (50) | 0 | 2 (29) | 0 | 1 (33) | 0 | 1 (33) | 0 | 1 (13) | 0 | 1 (14) | 0 | 3 (50) | 0 | 10 (28) | 0 |
| Pyrexia | 1 (50) | 0 | 3 (43) | 0 | 0 | 0 | 1 (33) | 0 | 2 (25) | 0 | 1 (14) | 0 | 1 (17) | 0 | 9 (25) | 0 |
| Vomiting | 1 (50) | 0 | 2 (29) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 (57) | 1 (14) | 0 | 1 (17) | 7 (19) | 2 (6) |
| Decreased appetite | 0 | 0 | 1 (14) | 0 | 1 (33) | 0 | 1 (33) | 0 | 2 (25) | 0 | 0 | 0 | 3 (50) | 0 | 8 (22) | 0 |
| Diarrhea | 1 (50) | 0 | 2 (29) | 0 | 0 | 0 | 0 | 0 | 1 (13) | 0 | 1 (14) | 0 | 1 (17) | 0 | 6 (17) | 0 |
| Platelet count decreased | 0 | 0 | 0 | 1 (14) | 1 (33) | 0 | 0 | 0 | 1 (13) | 0 | 0 | 0 | 2 (33) | 1 (17) | 4 (11) | 2 (6) |
| Abdominal pain | 0 | 1 (50) | 0 | 0 | 0 | 0 | 1 (33) | 0 | 1 (13) | 0 | 1 (14) | 0 | 2 (33) | 0 | 5 (14) | 1 (3) |
| Cough | 0 | 0 | 5 (71) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 (14) | 0 |
| Dyspnea | 1 (50) | 0 | 3 (43) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (14) | 0 | 0 | 0 | 5 (14) | 0 |
| Insomnia | 0 | 0 | 2 (29) | 0 | 1 (33) | 0 | 0 | 0 | 0 | 0 | 2 (29) | 0 | 0 | 0 | 5 (14) | 0 |
| Lower respiratory tract infection | 0 | 0 | 2 (29) | 0 | 0 | 0 | 0 | 0 | 1 (13) | 1 (13) | 1 (14) | 0 | 0 | 0 | 4 (11) | 1 (3) |
| White blood cell count decreased | 0 | 1 (50) | 0 | 0 | 0 | 0 | 0 | 1 (33) | 0 | 1 (13) | 0 | 2 (29) | 0 | 0 | 0 | 5 (14) |
| Alanine aminotransferase increased | 0 | 0 | 1 (14) | 0 | 0 | 0 | 1 (33) | 0 | 0 | 1 (13) | 0 | 0 | 1 (17) | 0 | 3 (8) | 1 (3) |
| Arthralgia | 0 | 0 | 1 (14) | 0 | 0 | 0 | 0 | 0 | 2 (25) | 0 | 0 | 0 | 1 (17) | 0 | 4 (11) | 0 |
| Neutrophil count decreased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33) | 0 | 1 (13) | 0 | 1 (14) | 0 | 1 (17) | 0 | 4 (11) |
| Aspartate aminotransferase increased | 0 | 0 | 1 (14) | 0 | 0 | 0 | 0 | 0 | 1 (13) | 1 (13) | 0 | 0 | 1 (17) | 0 | 3 (8) | 1 (3) |
| Contusion | 0 | 0 | 1 (14) | 0 | 2 (67) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 4 (11) | 0 |
| Dizziness | 0 | 0 | 0 | 0 | 0 | 0 | 1 (33) | 0 | 2 (25) | 0 | 1 (14) | 0 | 0 | 0 | 4 (11) | 0 |
| Hypocalcemia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 (25) | 0 | 1 (14) | 0 | 1 (17) | 0 | 4 (11) | 0 |
| Upper respiratory tract infection | 0 | 0 | 3 (43) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (17) | 0 | 4 (11) | 0 |
Note: Numbers in each column are “patients, n (%)” with specific preferred term and CTCAE grade. Cohort 1, 20 mg twice daily (BID) ceralasertib 17 days + carboplatin; cohort 2, 20 mg BID ceralasertib 10 days + carboplatin; cohort 3, 40 mg BID ceralasertib 10 days + carboplatin; cohort 4, 40 mg BID ceralasertib 7 days + carboplatin; cohort 5, 60 mg once daily (QD) ceralasertib 7 days + carboplatin; cohort 6, co-dosing 60 mg QD ceralasertib + carboplatin days 1–3; cohort 7, co-dosing 40 mg QD ceralasertib + carboplatin days 1 and 2. Each patient has only been represented with the maximum reported CTCAE grade for each system organ class/preferred term. Includes adverse events with an onset date on or after the date of the first dose (earliest date of first dose of ceralasertib or carboplatin), up to and including 28 days following the date of the last dose (latest date of last dose of ceralasertib or carboplatin).