Baseline patient and disease characteristics
| Parameter | Part 1 phase I (n = 56) | Part 2A phase II (n = 42) |
|---|---|---|
| Age, median (range), y | 51 (21–71) | 57 (42–84) |
| Gender, n (%) | ||
| Female | 51 (91.1) | 42 (100.0) |
| Male | 5 (8.9) | 0 (0) |
| ECOG PS, n (%) | ||
| 0 | 29 (51.8) | 26 (61.9) |
| 1 | 27 (48.2) | 16 (38.1) |
| Germline BRCA1/2 mutation, n (%) | ||
| Yes | 36 (64.3) | 42 (100.0) |
| No mutation detected | 9 (16.1) | 0 (0) |
| No test performeda | 11 (19.6) | 0 (0) |
| BRCA gene mutation, n (%) | ||
| BRCA1 | 22 (39.3) | 30 (71.4) |
| BRCA2 | 14 (25.0) | 12 (28.6) |
| Type of cancer, n (%) | ||
| Breast | 27 (48.2) | 0 (0) |
| Ovarian | 20 (35.7) | 42 (100.0) |
| Pancreatic (exocrine) | 2 (3.6) | 0 (0) |
| Otherb | 7 (12.5) | 0 (0) |
| Histologic classification, n (%) | ||
| Serous | NA | 37 (88.1) |
| Mixed | NA | 3 (7.1) |
| Endometrioid | NA | 1 (2.4) |
| Clear cell | NA | 1 (2.4) |
| Platinum status of patients with ovarian cancer, n (%)c | ||
| Refractory | 1 (1.8) | 0 (0) |
| Resistant | 11 (19.6) | 0 (0) |
| Sensitive | 8 (14.3) | 42 (100.0) |
| Progression-free interval from last platinum therapy, n (%) | ||
| ≥6–12 mo | NA | 32 (76.2) |
| >12 mo | NA | 10 (23.8) |
| Previous anticancer therapies, median (range) | 4 (1–15) | 2 (2–4) |
| ≥3 previous anticancer therapies, n (%) | 41 (73.2) | 15 (35.7) |
| Previous chemotherapies, median (range) | 3 (1–13) | 2 (2–4) |
| ≥3 previous chemotherapies, n (%) | 37 (66.1) | 15 (35.7) |
| Previous platinum-based chemotherapies, median (range) | 1 (0–5) | 2 (2–4) |
| ≥3 previous platinum-based chemotherapies, n (%) | 9 (16.1) | 13 (31.0) |
Abbreviation: NA, not applicable.
↵aPatients did not have local or central BRCA testing performed.
↵bOne each of the following: small-cell lung cancer, gastric cancer, colon cancer, desmoplastic round cell tumor, mesenchymal chondrosarcoma of the skull, astrocytoma, and angiosarcoma.
↵cPlatinum status was not applicable for 36 patients (64.3%) in part 1.