Table 1.

Baseline patient and disease characteristics

ParameterPart 1 phase I (n = 56)Part 2A phase II (n = 42)
Age, median (range), y51 (21–71)57 (42–84)
Gender, n (%)
 Female51 (91.1)42 (100.0)
 Male5 (8.9)0 (0)
ECOG PS, n (%)
 029 (51.8)26 (61.9)
 127 (48.2)16 (38.1)
Germline BRCA1/2 mutation, n (%)
 Yes36 (64.3)42 (100.0)
 No mutation detected9 (16.1)0 (0)
 No test performeda11 (19.6)0 (0)
BRCA gene mutation, n (%)
BRCA122 (39.3)30 (71.4)
BRCA214 (25.0)12 (28.6)
Type of cancer, n (%)
 Breast27 (48.2)0 (0)
 Ovarian20 (35.7)42 (100.0)
 Pancreatic (exocrine)2 (3.6)0 (0)
 Otherb7 (12.5)0 (0)
Histologic classification, n (%)
 SerousNA37 (88.1)
 MixedNA3 (7.1)
 EndometrioidNA1 (2.4)
 Clear cellNA1 (2.4)
Platinum status of patients with ovarian cancer, n (%)c
 Refractory1 (1.8)0 (0)
 Resistant11 (19.6)0 (0)
 Sensitive8 (14.3)42 (100.0)
Progression-free interval from last platinum therapy, n (%)
 ≥6–12 moNA32 (76.2)
 >12 moNA10 (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.