TABLE 1.
Demographic and Baseline Disease Characteristics by Dose Level
| Characteristic | Unesbulin 200 mg + DTIC 1,000 mg/m2 (n = 4) | Unesbulin 300 mg + DTIC 1,000 mg/m2 (n = 33)a | Unesbulin 400 mg + DTIC 1,000 mg/m2 (n = 4) | All Subjects (N = 41) |
|---|---|---|---|---|
| Age, years | ||||
| Mean (SD) | 67.8 (4.50) | 58.1 (10.74) | 61.8 (7.80) | 59.4 (10.36) |
| Median | 67.0 | 61.0 | 62.0 | 62.0 |
| Min-max | 64-73 | 32-73 | 52-71 | 32-73 |
| Sex, No. (%) | ||||
| Male | 0 | 7 (21.2) | 0 | 7 (17.1) |
| Female | 4 (100.0) | 26 (78.8) | 4 (100.0) | 34 (82.9) |
| Race, No. (%)b | ||||
| White | 2 (50.0) | 23 (69.7) | 4 (100.0) | 29 (70.7) |
| Black or African American | 1 (25.0) | 5 (15.2) | 0 | 6 (14.6) |
| Asian | 0 | 1 (3.0) | 0 | 1 (2.4) |
| Multiple | 0 | 1 (3.0) | 0 | 1 (2.4) |
| Other | 0 | 2 (6.1) | 0 | 2 (4.9) |
| Not reported | 1 (25.0) | 1 (3.0) | 0 | 2 (4.9) |
| Weight at baseline, kg | ||||
| Mean (SD) | 72.85 (10.206) | 81.49 (20.384) | 93.65 (37.723) | 81.83 (21.658) |
| Min-max | 62.8-84.6 | 44.7-122.0 | 54.8-143.0 | 44.7-143.0 |
| BMI at baseline, kg/m2c | ||||
| Mean (SD) | 29.48 (3.672) | 29.42 (6.976) | 33.78 (15.406) | 29.85 (7.710) |
| Min-max | 25.8-34.5 | 17.5-46.0 | 21.2-55.2 | 17.5-55.2 |
| ECOGd | ||||
| 0 | 3 (75.0) | 21 (63.6) | 0 | 24 (58.5) |
| 1 | 1 (25.0) | 12 (36.4) | 4 (100.0) | 17 (41.5) |
| Type of LMS, No. (%) | ||||
| Uterine | 1 (25.0) | 19 (57.6) | 1 (25.0) | 21 (51.2) |
| Nonuterine | 3 (75.0) | 14 (42.4) | 3 (75.0) | 20 (48.8) |
| Male | 0 | 7 (50.0) | 0 | 7 (35.0) |
| Female | 3 (100) | 7 (50.0) | 3 (100) | 13 (65.0) |
| Previous lines of therapy, No. (%) | ||||
| 1 | 1 (25.0) | 3 (9.1) | 1 (25.0) | 5 (12.2) |
| 2 | 1 (25.0) | 5 (15.2) | 0 | 6 (14.6) |
| 3 | 0 | 9 (27.3) | 2 (50.0) | 11 (26.8) |
| 4 or more | 2 (50.0) | 16 (48.5) | 1 (25.0) | 19 (46.3) |
| Previous anticancer therapy, No. (%) | ||||
| Anthracycline | 4 (100) | 31 (93.9) | 4 (100) | 39 (95.1) |
| Gemcitabine | 3 (75.0) | 26 (78.8) | 3 (75.0) | 32 (78.0) |
| Taxane | 3 (75.0) | 25 (75.8) | 2 (50.0) | 30 (73.2) |
| Trabectedin | 2 (50.0) | 12 (36.4) | 0 | 14 (34.1) |
| DTIC | 0 | 4 (12.1) | 0 | 4 (9.8) |
| Pazopanib | 2 (50.0) | 10 (30.3) | 0 | 12 (29.3) |
Abbreviations: DTIC, dacarbazine; ECOG, Eastern Cooperative Oncology Group; LMS, leiomyosarcoma; max, maximum; min, minimum; SD, standard deviation.
Includes all subjects who were treated with unesbulin 300 mg, including subjects who participated in the dose-finding and expansion parts of the study.
More than one choice could be selected, so percentages may total >100%.
BMI was calculated as the individual’s body mass divided by the square of their height, with the value universally being given in units of kg/m2.
ECOG score: 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (eg, light housework, office work); 2 = ambulatory and capable of all self-care, but unable to carry out any work activities; up and about more than 50% of waking hours; 3 = capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = completely disabled; cannot carry on any self-care; totally confined to bed or chair; 5 = dead.