Table 1.

Clinical trials exploring talazoparib in ovarian cancer (www.clinicaltrials.gov)

Study	Phase	Patient s (n)	Description	Population	Outcome	Trial, status
de Bono et al. [13]	I	113	Talazoparib 1 mg daily	1. Solid tumors (34/113 platinum-treated EOC, primary peritoneal or fallopian tube cancer) 2. gBRCAm (25/34 EOC)	1. ORR: 41.7% 2. gBRCAm: ORR: 55% in platinum-sensitive ORR: 20% in platinum-resistant 3. PFS: 36.4 mo	NCT01286987 Completed
Dhawan et al. [72]	I	24	Talazoparib + carboplatin Talazoparib starting dose of 0.75 mg daily One cycle equaled 21 days	1. Solid tumors (2/24 EOC) 2. 14/24 (58%) of patients received prior platinum CTH 3. gBRCAm (7/24, 29%) 4. sBRCAm (3/24, 12.5%)	1. 14% ORR 2. 52% SD 3. Dose reduction: 50% 4. Dose interruptions: 75% 5. Pharmacokinetics	Completed
POSITION [73]	I	30	Talazoparib 1 mg daily	1. EOC, primary peritoneal or fallopian tube cancer 2. Neoadjuvant setting	Basal levels and effects of talazoparib on DNA copy number, LOH, and mutation, and level of RNA and protein expression in HRD-related pathways before and after treatment	NCT02316834 Ongoing
NCT02326844 [74]	II	3	Talazoparib 1 mg daily	1. Recurrent and/or metastatic EOC 2. Progression on PARP inhibitors monotherapy 3. gBRCAm	1. Objective response (CR + PR) 2. Safety 3. Duration of response 4. PFS	NCT02326844 Terminated (closed by the Cancer Therapy Evaluation Program)
NCT02836028 [75]	II	N/A	Arm 1: talazoparib 1 mg daily Arm 2: talazoparib 1 mg daily + temozolomide 37.5 mg/m2 on days 1–5	1. Recurrent EOC, primary peritoneal or fallopian tube cancer 2. <3 prior lines of CTH 3. gBRCAm, or sBRCAm, or HRD(+)	ORR	NCT02836028 Withdrawn

BRCA breast cancer susceptibility genes, CR complete response, CTH chemotherapy, EOC epithelial ovarian cancer, HRD homologous recombination deficiency, LOH loss of heterozygosis, mo months, ORR objective response rate, PARP poly(ADP-ribose) polymerase, PFS progression-free survival, PR partial response, SD stable disease