Phase Ib (n=16) | Phase II (n=52) | |
Median age (range) (months) | 38 (25–78) | 43 (19–77) |
Sex (male/female), n (%) | 10 (63)/6 (37) | 30 (58)/22 (42) |
Primary tumor localization, n (%) | ||
Somatic | 15 (94) | 44 (85) |
Visceral | 1 (6) | 8 (15) |
Primary tumor depth, n (%) | ||
Deep | 16 (100) | 40 (77) |
Superficial | 0 | 9 (17) |
UK | 0 | 3 (6) |
Extension at diagnosis, n (%) | ||
Localized | 9 (56) | 25 (48) |
Locally advanced | 2 (13) | 15 (29) |
Metastatic | 5 (31) | 12 (23) |
Resectable at diagnosis, n (%) | ||
Resectable | 10 (63) | 38 (73) |
Unresectable | 6 (37) | 14 (27) |
Median metastatic-free interval (range) (months) | 8 (0–80) | 11 (0–141) |
Extension at baseline, n (%) | ||
Locally advanced | 0 | 4 (8) |
Metastatic | 16 (100) | 48 (92) |
Diagnosis (central), n (%) | ||
Synovial sarcoma | 2 (13) | 9 (17) |
UPS | 2 (13) | 8 (15) |
Clear cell sarcoma | 4 (25) | 7 (14) |
Solitary fibrous tumor | 0 | 7 (14) |
Epithelioid sarcoma | 0 | 7 (14) |
Angiosarcoma | 2 (13) | 5 (10) |
Extraskeletal myxoid chondrosarcoma | 0 | 4 (7) |
Alveolar soft part sarcoma | 3 (19) | 4 (7) |
Epithelioid hemangioendothelioma | 0 | 1 (2) |
Osteosarcoma* | 2 (13) | 0 |
Chondrosarcoma* | 1 (6) | 0 |
ECOG PS at baseline, n (%) | ||
0 | 6 (37) | 25 (48) |
1 | 10 (63) | 27 (52) |
Median previous lines (range) | 1.5 (0–5) | 1 (0–4) |
Previous antiangiogenic lines, n (%) | ||
0 | 14 (88) | 41 (79) |
1 | 2 (12) | 10 (19) |
2 | 0 | 1 (2) |
*Included in phase Ib.
ECOG PS, Eastern Cooperative Oncology Group performance status; UK, unknown; UPS, undifferentiated pleomorphic sarcoma.