Table 5. Phase II/III studies of veliparib in combination with chemotherapy in ovarian cancer (www.clinicaltrials.gov).
| Author, year of publication (reference) | Phase | Enrolled patients | Treatment arms | Setting | Results | Trial |
|---|---|---|---|---|---|---|
| (45) | III | 1,140 | Arm [1]: carboplatin + paclitaxel followed by maintenance placebo | Advanced HGSOC Any BRCA mutation |
Waiting results |
NCT02470585 (GOG 3005), active, not recruiting |
| Arm [2]: carboplatin + paclitaxel + veliparib followed by maintenance placebo | ||||||
| Arm [3]: carboplatin + paclitaxel + veliparib followed by maintenance veliparib | ||||||
| Kummar S, et al., 2015 (55) | II | 72 | Arm (A): cyclophosphamide (50 mg OD) | Primary peritoneal, fallopian tube, or HGSOC | ORR on arm (A): 36% | NCT01306032, completed |
| Arm (B): cyclophosphamide (50 mg OD) + veliparib (60 mg OD) | ORR on arm (B): 26% | |||||
| PFS on arm (A): 2.3 m | ||||||
| Any BRCA mutation | PFS on arm (B): 2.1 m | |||||
| Hjortkjær M, et al., 2018 (56) | I/II | 27 | 3+3 dose-escalation trial | Primary peritoneal, fallopian tube | Phase I study veliparib MTD: 30mg BID | NCT01690598, completed |
| 4-week cycle treatment | Platinum-resistant or partially sensitive OC | Phase II study topotecan MTD: 2 mg/m2 | ||||
| Phase I: 12 patients | BRCA1/2 unknown/wild-type | ORR: 37% | ||||
| Phase II: 15 patients | PFS: 2.8 m | |||||
| Experimental treatment arm: veliparib (BID, days 1–3, 8–10 and 15–17) + topotecan (days 2, 9 and 16) | OS: 7.1 m | |||||
| (57) | II | 168 | Arm [1]: veliparib + temozolomide | Recurrent HGSOC | Waiting results | NCT01113957, completed |
| Arm [2]: PLD | Germline BRCA | |||||
| Sporadic OC |
HGSOC, high-grade serous ovarian cancer; BRCA, breast cancer gene; OD, once a day (omne in die); ORR, overall response rate; PFS, progression-free survival; m, months; OC, ovarian cancer; MTD, maximum tolerated dose; BID, twice a day (bis in die); OS, overall survival; PLD, pegylated liposomal doxorubicin.