Table 1.
Baseline characteristics of patients in each dose group
| 120 3/4 | 160 3/4 | 160 3/4, 2/1w | All patients | |
|---|---|---|---|---|
| (n = 25) | (n = 67) | (n = 27) | (N = 119) | |
| Sex, no. (%) | ||||
| Male | 10 (40.0) | 25 (37.3) | 11 (40.7) | 46 (38.7) |
| Female | 15 (60.0) | 42 (52.7) | 16 (59.3) | 73 (61.3) |
| Age, years | ||||
| Median (range) | 64 (39–76) | 61 (36–77) | 68 (30–77) | 63 (30–77) |
| 65 and older, no. (%) | 12 (48.0) | 23 (34.3) | 16 (59.3) | 51 (42.9) |
| ECOG status, no. (%) | ||||
| 0 | 11 (44.0) | 34 (50.7) | 17 (63.0) | 62 (52.1) |
| 1 | 14 (56.0) | 33 (49.3) | 10 (37.0) | 57 (47.9) |
| Lines of prior systemic therapy, no. (%) | ||||
| 3 or less | 12 (48.0) | 45 (67.2) | 20 (74.1) | 77 (64.7) |
| 4 or more | 13 (52.0) | 22 (32.8) | 7 (25.9) | 42 (35.3) |
| Prior platinum, no. (%) | 14 (56.0) | 43 (64.2) | 22 (81.5) | 79 (66.4) |
| Prior PARP inhibitor, no. (%) | 8 (32.0) | 24 (35.8) | 10 (37.0) | 42 (35.3) |
| Tumor type, no. (%) | ||||
| Ovarian | 5 (20.0) | 11 (16.4) | 7 (25.9) | 23 (19.3) |
| Breast | 2 (8.0) | 9 (13.4) | 4 (14.8) | 15 (12.6) |
| Pancreas | 0 | 10 (14.9) | 4 (14.8) | 14 (11.8) |
| Prostate | 6 (24.0) | 6 (9.0) | 2 (7.4) | 14 (11.8) |
| Othera | 12 (48.0) | 31 (46.3) | 10 (37.0) | 53 (44.5) |
| Enrollment gene, no. (%) | ||||
| ATM | 5 (20.0) | 25 (37.3) | 8 (29.6) | 38 (31.9) |
| BRCA1 | 4 (16.0) | 15 (22.4) | 9 (33.3) | 28 (23.5) |
| BRCA2 | 4 (16.0) | 8 (11.9) | 3 (11.1) | 15 (12.6) |
| SETD2 | 3 (12.0) | 6 (9.0) | 1 (3.7) | 10 (8.4) |
| CDK12 | 3 (12.0) | 3 (4.5) | 1 (3.7) | 7 (5.9) |
| NBN | 0 | 3 (4.5) | 2 (7.4) | 5 (4.2) |
| PALB2 | 3 (12.0) | 2 (3.0) | 0 | 5 (4.2) |
| Otherb | 3 (12.0) | 5 (7.5) | 3 (11.1) | 11 (9.2) |
| Baseline hematology, median | ||||
| Hemoglobin, g/dL | 11.3 | 11.9 | 11.9 | 11.9 |
| Neutrophils, K/μL | 3.9 | 4.2 | 3.7 | 4.1 |
| Platelets, K/μL | 215 | 257 | 231 | 231 |
a
Other includes colorectal (n = 8), soft-tissue sarcoma (n = 8), non-small cell lung cancer (n = 7), kidney (n = 4), bile duct (n = 4), endometrial (n = 3), head and neck (n = 3), gastrointestinal (n = 3), and other less frequent tumor types (n = 13). 2/1w = 2 weeks on, 1 week off; 120 3/4 = 120 mg QD 3 days on, 4 days off; 160 3/4 = 160 mg QD 3 days on, 4 days off; ECOG = Eastern Cooperative Oncology Group; K/μL = thousand cells per microliter; PARP = poly (ADP-ribose) polymerase; QD = once daily.
b
Other includes CHEK2 (n = 2), RAD51B (n = 2), RAD51C (n = 4), and RNASEH2 (n = 3).