TABLE 1.
Patient demographics and baseline characteristics
| Characteristics | Dose escalation | Expansion | Total (N = 21) | ||
|---|---|---|---|---|---|
| 750 mg (n = 6) | 1000 mg (n = 3) | 1400 mg (n = 6) | 1000 mg (n = 6) | ||
| Gender, n (%) | |||||
| Male | 2 (33.3) | 2 (66.7) | 5 (83.3) | 4 (66.7) | 13 (61.9) |
| Female | 4 (66.7) | 1 (33.3) | 1 (16.7) | 2 (33.3) | 8 (38.1) |
| Median age, years (range) | 66 (46‐70) | 68 (56‐69) | 68 (48‐74) | 38 (32‐71) | 66 (32‐74) |
| ECOG PS, n (%) | |||||
| 0 | 4 (66.7) | 2 (66.7) | 4 (66.7) | 5 (83.3) | 15 (71.4) |
| 1 | 2 (33.3) | 1 (33.3) | 2 (33.3) | 1 (16.7) | 6 (28.6) |
| Primary tumor type, n (%) | |||||
| Adrenal | 1 (16.7) | 0 | 1 (16.7) | 0 | 2 (9.5) |
| Colorectal | 1 (16.7) | 0 | 1 (16.7) | 0 | 2 (9.5) |
| Esophagus | 1 (16.7) | 0 | 2 (33.3) | 0 | 3 (14.3) |
| Gastrointestinal tract | 0 | 1 (33.3) | 0 | 0 | 1 (4.8) |
| Non–small‐cell lung cancer | 0 | 1 (33.3) | 1 (16.7) | 0 | 2 (9.5) |
| Soft tissue/ossifying sarcoma | 0 | 0 | 0 | 2 (33.3) | 2 (9.5) |
| Stomach | 1 (16.7) | 1 (33.3) | 1 (16.7) | 1 (16.7) | 4 (19.0) |
| Other | 2 (33.3) | 0 | 0 | 3 (50.0) | 5 (23.8) a |
| Number of metastatic sites at screening, n (%) | |||||
| 1 | 3 (50.0) | 1 (33.3) | 0 | 3 (50.0) | 7 (33.3) |
| 2 | 1 (16.7) | 1 (33.3) | 2 (33.3) | 2 (33.3) | 6 (28.6) |
| ≥3 | 2 (33.3) | 1 (33.3) | 4 (66.7) | 1 (16.7) | 8 (38.1) |
| Prior surgery, n (%) | 4 (66.7) | 2 (66.7) | 5 (83.3) | 4 (66.7) | 15 (71.4) |
| Prior radiotherapy, n (%) | 1 (16.7) | 1 (33.3) | 2 (33.3) | 2 (33.3) | 6 (28.6) |
| Prior hormone therapy, n (%) | 1 (16.7) | 0 | 0 | 2 (33.3) | 3 (14.3) |
| Number of previous systemic chemotherapies, n (%) | |||||
| 0 | 0 | 0 | 0 | 1 (16.7) | 1 (4.8) |
| 1 | 0 | 0 | 1 (16.7) | 2 (33.3) | 3 (14.3) |
| 2 | 0 | 0 | 0 | 1 (16.7) | 1 (4.8) |
| 3 | 2 (33.3) | 0 | 1 (16.7) | 2 (33.3) | 5 (23.8) |
| 4 | 0 | 2 (66.7) | 0 | 0 | 2 (9.5) |
| ≥5 | 4 (66.7) | 1 (33.3) | 4 (66.7) | 0 | 9 (42.9) |
Abbreviation: ECOG PS, Eastern Cooperative Oncology Group performance status.
a
Other tumor types; 750 mg cohort: neuroendocrine carcinoma and breast cancer; 1000 mg cohort: retroperitoneal solitary fibrous tumor and desmoid‐type fibromatosis (n = 2).