Table 3.
Best overall response in the dose-escalation and dose-expansion cohorts
| Dose-escalation cohorts | |||||||||
| Central Reada | |||||||||
| Tumor Response, | 1, 2, 4, 8 mg | 16 mg | 24 mg | 25 mg | 30 mg | 30 mg + G-CSF | 35 mg + G-CSF | 40 mg + G-CSF | 50 mg + G-CSF |
| Patients (%) | (n = 4) | (n = 3) | (n = 6) | (n = 7) | (n = 6) | (n = 6) | (n = 3) | (n = 11) | (n = 4) |
| Complete response | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Partial response | 0 | 0 | 0 | 0 | 1 (17)b | 0 | 0 | 0 | 0 |
| Stable disease | 2 (50) | 2 (67) | 5 (83) | 4 (57) | 3 (50) | 3 (50) | 1 (33) | 7 (64) | 2 (50) |
| Progressive disease | 2 (50) | 0 | 1 (17) | 1 (14) | 1 (17) | 3 (50) | 2 (67) | 2 (18) | 0 |
| Unable to evaluate | 0 | 1 (33) | 0 | 2 (29) | 1 (17) | 0 | 0 | 2 (18) | 2 (50) |
| Dose-expansion cohorts | |||||||||
| Central Reada | Local Readc | GCIG Criteriad | |||||||
| Tumor Response, | OC | TNBC | CRPC | OC | TNBC | CRPC | OC | ||
| Patients (%) | (n = 29) | (n = 14) | (n = 12) | (n = 29) | (n = 14) | (n = 12) | (n = 29) | ||
| Complete response | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| Partial response | 3 (10) | 0 | 0 | 3 (10) | 1 (7) | 0 | 7 (24) | ||
| Stable disease | 21 (72) | 7 (50) | 9 (75) | 20 (69) | 5 (36) | 8 (67) | 16 (55) | ||
| Progressive disease | 3 (10) | 4 (29) | 1 (8) | 4 (14) | 5 (36) | 3 (25) | 3 (10) | ||
| Not evaluablee | 2 (7) | 3 (21) | 2 (17) | 2 (7) | 3 (21) | 1 (8) | 3 (10) | ||
| Progression-free survival, median (80% CI), weeks | 31.7 (23.7–47.6) | 7.6 (4.1–23.6) | 32.4 (15.7–39.6) | NA | NA | NA | NA | ||
CRPC castration-resistant prostate cancer, GCIG Gynecologic Cancer InterGroup, G-CSF granulocyte colony-stimulating factor, NA not available, OC ovarian cancer, RECIST response evaluation criteria in solid tumors, TNBC triple-negative breast cancer
a
Per RECIST 1.1
b
This patient also had a response by GCIG CA 125 criteria
c
Per RECIST 1.0
d
Per GCIG criteria: RECIST 1.1 and CA 125 [22]
e
Postbaseline scan not readable