Table 1.
Patient demographics and baseline disease characteristics
| Parameter | Part A | Part B | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Safety lead-in (200 mg)a | Safety lead-in (175 mg)b | Ovarian cancer, BRCAwt | Ovarian cancer, BRCAm, PARPi failure | TNBC, CCNE1/MYC/ MYCL1/MYCN non-amplified | TNBC, CCNE1/MYC/ MYCL1/MYCN amplified | SCLC, CCNE1/MYC/ MYCL1/MYCN non-amplified | SCLC, CCNE1/MYC/ MYCL1/MYCN amplified | Total (part B) | |
| Patients who received treatment, n | 7 | 5 | 16 | 30 | 13 | 6 | 12 | 3 | 80 |
| Median age, years (range) | 58 (41–76) | 51 (28–64) | 62.5 (47–83) | 59.5 (44–73) | 58.0 (35–81) | 54.0 (43–78) | 64.5 (54–74) | 63.0 (56–59) | 60.0 (35–83) |
| Gender, n (%) | |||||||||
| Female | 5 (71.4) | 2 (40.0) | 16 (100) | 30 (100) | 13.0 (100) | 6.0 (100) | 6 (50.0) | 2 (66.7) | 73 (91.3) |
| Male | 2 (28.6) | 3 (60.0) | 0 | 0 | 0 | 0 | 6 (50.0) | 1 (33.3) | 7 (8.8) |
| Prior regimens, n (%) | |||||||||
| 1 | 1 (14.3) | 1 (20.0) | 0 | 0 | 0 | 0 | 3 (25.0) | 0 | 3 (3.8) |
| 2 | 1 (14.3) | 2 (40.0) | 0 | 0 | 3 (23.1) | 0 | 5 (41.7) | 1 (33.3) | 9 (11.3) |
| 3 | 1 (14.3) | 1 (20.0) | 1 (6.3) | 2 (6.7) | 2 (15.4) | 1 (16.7) | 3 (25.0) | 2 (66.7) | 11 (13.8) |
| 4 | 3 (42.9) | 0 | 3 (18.8) | 3 (10.0) | 1 (7.7) | 2 (33.3) | 0 | 0 | 9 (11.3) |
| 5 | 0 | 1 (20.0) | 2 (12.5) | 7 (23.3) | 2 (15.4) | 2 (33.3) | 1 (8.3) | 0 | 14 (17.5) |
| 6 | 0 | 0 | 1 (6.3) | 8 (26.7) | 3 (23.1) | 1 (16.7) | 0 | 0 | 13 (16.3) |
| > 6 | 1 (14.3) | 0 | 9 (56.0) | 10 (33.3) | 2 (15.4) | 0 | 0 | 0 | 21 (26.3) |
| Median (range) no. of prior regimens | 4 (1–12) | 2 (1–5) | 7 (3–15) | 6 (3–12) | 5 (2–8) | 4.5 (3–6) | 2 (1–5) | 3 (2–3) | 5 (1–15) |
| ECOG PS, n (%) | |||||||||
| 0 | 5 (71.4) | 2 (40.0) | 8 (50.0) | 10 (33.3) | 4 (30.8) | 1 (16.7) | 2 (16.7) | 1 (33.3) | 26 (32.5) |
| 1 | 2 (28.6) | 3 (60.0) | 8 (50.0) | 20 (67.7) | 9 (69.2) | 5 (83.3) | 10 (83.3) | 2 (66.7) | 54 (67.5) |
| Tumor grade, n (%) | |||||||||
| G1 | 0 | 0 | 1 (6.3) | 2 (6.7) | 1 (7.7) | 0 | 1 (8.3) | 0 | 5 (6.3) |
| G2 | 0 | 0 | 0 | 2 (6.7) | 3 (23.1) | 1 (16.7) | 0 | 0 | 6 (7.5) |
| G3 | 5 (71.4) | 2 (40.0) | 10 (62.5) | 17 (56.7) | 9 (69.2) | 5 (83.3) | 2 (16.7) | 0 | 43 (53.8) |
| G4 | 0 | 0 | 1 (6.3) | 4 (13.3) | 0 | 0 | 0 | 1 (33.3) | 6 (7.5) |
| GX | 2 (28.6) | 3 (60.0) | 2 (12.5) | 2 (6.7) | 0 | 0 | 9 (75.0) | 2 (66.7) | 15 (18.6) |
| Missing | 0 | 0 | 2 (12.5) | 3 (10.0) | 0 | 0 | 0 | 0 | 5 (6.3) |
| Primary diagnosis, n (%) | |||||||||
| Ovary | 2 (28.6) | 0 | 15 (93.8) | 28 (93.3) | 0 | 0 | 0 | 0 | 43 (53.8) |
| Lung | 2 (28.6) | 3 (60.0) | 0 | 0 | 0 | 0 | 12 (100) | 3 (100) | 15 (18.8) |
| Breast | 0 | 0 | 0 | 0 | 13 (100) | 6 (100) | 0 | 0 | 19 (23.8) |
| Fallopian tube | 0 | 0 | 1 (6.3) | 2 (6.7) | 0 | 0 | 0 | 0 | 3 (3.8) |
| Head/neck | 1 (14.3) | 1 (20.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Pancreas | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown | 1 (14.3) | 1 (20.0) | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Histology type, n (%) | |||||||||
| Adenocarcinoma | 3 (42.9) | 0 | 1 (6.3) | 12 (40.0) | 1 (7.7) | 0 | 0 | 0 | 14 (17.5) |
| Adenosquamous carcinoma | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Carcinoma in situ | 0 | 0 | 0 | 0 | 1 (7.7) | 0 | 0 | 0 | 1 (1.3) |
| Carcinomac | 1 (14.3) | 1 (20.0) | 3 (18.8) | 8 (26.7) | 0 | 0 | 1 (8.3) | 0 | 12 (15.0) |
| Invasive carcinomac | 0 | 0 | 0 | 1 (3.3) | 1 (7.7) | 0 | 0 | 0 | 2 (2.5) |
| Invasive ductal carcinoma | 0 | 0 | 0 | 0 | 9 (69.2) | 6 (100.0) | 0 | 0 | 15 (18.8) |
| Small-cell carcinoma | 1 (14.3) | 3 (60.0) | 0 | 0 | 0 | 0 | 10 (83.3) | 3 (100.0) | 13 (16.3) |
| Squamous cell carcinoma | 1 (14.3) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Other | 0 | 1 (20.0) | 12 (75.0) | 9 (30.0) | 1 (7.7) | 0 | 1 (8.3) | 0 | 23 (28.8) |
BRCAm breast cancer gene 1/2 mutation, BRCAwt breast cancer gene 1/2 wild type, CCNE1 cyclin E1, ECOG PS Eastern Cooperative Oncology Group performance status, G1 well differentiated, G2 moderately differentiated, G3 poorly differentiated, G4 undifferentiated, GX tumor grade not assessable, n number of patients, PARPi poly(ADP-ribose) polymerase inhibitor, SCLC small-cell lung cancer, TNBC triple-negative breast cancer
aOf the seven patients in this group, two (28.6%) had a primary diagnosis of ovarian cancer, two (28.6%) lung cancer, one (14.3%) head/neck cancer, one (14.3%) pancreatic cancer, and one (14.3%) unknown
bOf the five patients in this group, three (60%) had a primary diagnosis of lung cancer, one (20.0%) head/neck cancer, and one (20.0%) unknown
cNot otherwise specified