Table 1.
Baseline Characteristics for Patients Enrolled in Part 2 (Intent‐To‐Treat Population)
| Ontuxizumab at 8 mg/kg + G/D (n = 139) | Placebo + G/D (n = 70) | Total (n = 209) | |
|---|---|---|---|
| Age, mean (SD), y | 55 (13) | 54 (14) | 55 (14) |
| Sex, No. (%) | |||
| Male | 76 (55) | 38 (54) | 114 (55) |
| Female | 63 (45) | 32 (46) | 95 (46) |
| Race, No. (%) | |||
| White | 116 (83) | 57 (81) | 173 (83) |
| Black or African American | 12 (9) | 9 (13) | 21 (10) |
| Other | 11 (8) | 4 (6) | 15 (7) |
| Initial histologic diagnosis grade, No. (%) | |||
| 1 | 3 (2) | 4 (6) | 7 (3) |
| 2 | 21 (15) | 13 (19) | 34 (16) |
| 3 | 82 (59) | 38 (54) | 120 (57) |
| Unknown | 22 (16) | 9 (13) | 31 (15) |
| Missing | 11 (8) | 6 (9) | 17 (8) |
| Baseline ECOG performance status, No. (%) | |||
| 0 | 67 (48) | 39 (56) | 106 (51) |
| 1 | 72 (52) | 31 (44) | 103 (49) |
| Prior chemotherapy in the metastatic setting | 74 (53) | 40 (57) | 114 (55) |
| First line | 65 (47) | 30 (43) | 95 (45) |
| Second line | 53 (38) | 29 (41) | 82 (39) |
| Third line | 21 (15) | 11 (16) | 32 (15) |
| Histologic subtype, No. (%) | |||
| Liposarcoma | 30 (22) | 15 (21) | 45 (22) |
| Leiomyosarcoma | 41 (29) | 21 (30) | 62 (30) |
| Undifferentiated pleomorphic sarcoma or myxofibrosarcoma | 30 (22) | 15 (21) | 45 (22) |
| Other | 38 (27) | 19 (27) | 57 (27) |
| Angiosarcoma | 3 | 2 | 5 |
| Spindle cell sarcoma | 3 | 2 | 5 |
| Peripheral nerve sheath tumor | 6 | 1 | 7 |
| Synovial sarcoma | 14 | 6 | 20 |
| Miscellaneous or unclassifieda | 12 | 8 | 20 |
Abbreviations: ECOG, Eastern Cooperative Oncology Group; G/D, gemcitabine and docetaxel; SD, standard deviation.
a
The miscellaneous and unclassified histologic subtypes included patients with histologic diagnoses of rhabdomyosarcoma (3), unclassified sarcoma (3), epithelioid sarcoma (3), hemangiopericytoma (2), endometrial sarcoma (2), adenosarcoma (1), clear cell sarcoma (1), fibrosarcoma (1), intimal sarcoma (1), phyllodes (1), other liposarcoma (1), and small blue round cell tumor (1).