Table 7. Phase I studies of talazoparib in ovarian cancer (www.clinicaltrials.gov).
| Author, year of publication (reference) | Enrolled patients | Treatment arms | Setting | Results | Trial |
|---|---|---|---|---|---|
| de Bono J, et al., 2017 (66) | 113 | Talazoparib 1 mg daily | 1. Solid tumors (34/113 platinum-treated EOC) | 1. ORR: 41.7% | NCT01286987 Completed |
| 2. gBRCAm (25/34 EOC) | 2. gBRCAm: ORR: 55% in platinum-sensitive; ORR: 20% in platinum-resistant | ||||
| 3. PFS: 36.4 months | |||||
| Dhawan MS, et al., 2017 (67) | 24 | Talazoparib + carboplatin | 1. Solid tumors (2/24 EOC) | 1. 14% ORR | Completed |
| Talazoparib starting dose of 0.75 mg daily | 2. 14/24 (58%) of patients received prior platinum CTH | 2. 52% SD | |||
| One cycle equaled 21 days | 3. gBRCAm (7/24, 29%) | 3. Dose reduction: 50% | |||
| 4. sBRCAm (3/24, 12.5%) | 4. Dose interruptions: 75% | ||||
| 5. Pharmacokinetics | |||||
| (68) | 30 | Talazoparib 1 mg daily | 1. EOC | Pending | NCT02316834 |
| 2. Neoadjuvant setting | Ongoing |
EOC, epithelial ovarian cancer; BRCA, breast cancer gene; gBRCAm, germline BRCA mutation; ORR, objective response rate; PFS, progression-free survival; CTH, chemotherapy; sBRCA, somatic BRCA mutation; SD, stable disease; LOH, loss of heterozygosis; HRD, homologous recombination deficiency.