Table 1.
Patient demographics and baseline clinical characteristics (PK analysis population)
| Normal renal function [n = 6] | Mild renal impairment [n = 7] | Moderate renal impairment [n = 8] | Severe renal impairment [n = 7] | All patients [n = 28] | |
|---|---|---|---|---|---|
| Age, years [median (range)] | 59.0 (52–70) | 66.0 (55–78) | 64.5 (56–74) | 77.0 (59–88) | 66.5 (52–88) |
| Sex, n (%) | |||||
| Female | 3 (50.0) | 5 (71.4) | 6 (75.0) | 4 (57.1) | 18 (64.3) |
| Male | 3 (50.0) | 2 (28.6) | 2 (25.0) | 3 (42.9) | 10 (35.7) |
| Race, n (%) | |||||
| White | 5 (83.3) | 7 (100.0) | 7 (87.5) | 6 (85.7) | 25 (89.3) |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 (16.7) | 0 | 0 | 1 (14.3) | 2 (7.1) |
| Other | 0 | 0 | 1 (12.5) | 0 | 1 (3.6) |
| Ethnicity, n (%) | |||||
| Hispanic or Latino | 0 | 0 | 1 (12.5) | 0 | 1 (3.6) |
| Not-Hispanic or Latino | 6 (100.0) | 7 (100.0) | 7 (87.5) | 7 (100.0) | 27 (96.4) |
| Weight, kg [median (range)] | 71.9 (43.8–96.4) | 63.4 (50.1–91.4) | 84.8 (55.1–115.0) | 70.4 (51.2–82.3) | 73.4 (43.8–115.0) |
| Height, cm [median (range)] | 162 (150–188) | 170 (154–176) | 164 (152–175) | 163 (146–183) | 164 (146–188) |
| BMI, kg/m2 [median (range)] | 25.8 (19.5–33.8) | 22.1 (17.3–35.4) | 30.8 (20.1–42.3) | 25.9 (21.9–33.4) | 25.9 (17.3–42.3) |
| Primary cancer site, n (%) | |||||
| Breast | 1 (16.7) | 0 | 0 | 0 | 1 (3.6) |
| Ovary | 2 (33.3) | 2 (28.6) | 4 (50.0) | 3 (42.9) | 11 (39.3) |
| Prostate | 2 (33.3) | 0 | 2 (25.0) | 1 (14.3) | 5 (17.9) |
| Othera | 1 (16.7) | 5 (71.4) | 2 (25.0) | 3 (42.9) | 11 (39.3) |
| ECOG performance, n (%) | |||||
| 0 | 2 (33.3) | 2 (28.6) | 1 (12.5) | 1 (14.3) | 6 (21.4) |
| 1 | 3 (50.0) | 5 (71.4) | 5 (62.5) | 4 (57.1) | 17 (60.7) |
| 2 | 1 (16.7) | 0 | 2 (25.0) | 2 (28.6) | 5 (17.9) |
Data are expressed as n (%) unless otherwise specified
BMI body mass index, ECOG Eastern Cooperative Oncology Group, PK pharmacokinetic
aOther primary cancer sites include the endometrium (three patients [10.7%]), gastric, biliary, pleura, sarcoma, bladder, colon, urinary bladder, and submandibular (one patient each [3.6%])