Table 3.

Clinical trials exploring single-agent talazoparib in solid tumors (www.clinicaltrials.gov)

Study	Phase	Patients (n)	Description	Population	Outcome	Trial, status
NCT02286687 [82]	II	150	Talazoparib 1 mg daily	1. Solid tumors 2. Somatic or gBRCAm 3. Genomic alterations in other BRCA pathway genes (ATM, PALB2, Fanconi Anemia genes, ARID1A, MER11, RAD50, NBS1, ATR)	1. CBR (CR, PR or SD >24 w) 2. PFS 3. OS 4. Baseline predictive molecular markers 5. Pharmacodynamics	NCT02286687 Recruiting
NCT01989546 [83]	I/II	24	Talazoparib 1 mg daily	1. Platinum-sensitive or -naïve EOC 2. Recurrent primary peritoneal, BC, prostate, pancreas, gastric, or other solid tumors following at least one standard therapy 3. Somatic or gBRCAm	1. Pharmacodynamics 2. ORR	NCT01989546 Recruiting
NCT02567396 [84]	I	0	Talazoparib daily Dose-escalation study	1. Advanced and/or metastatic solid tumors (CRPC, pancreatic, mesothelioma, gastric, NSCLC, SCLC, EOC, TNBC) 2. Patients with varying degrees of hepatic and renal dysfunction	1. Safety 2. RP2D 3. Tolerability 4. Biomarkers of response and resistance 5. ORR 6. Pharmacokinetics 7. PFS 8. Pharmacodynamics	NCT02567396 Withdrawn
Konstantinopoulos et al. [118]	I	10	Arm 1: talazoparib 1 mg PO daily Arm 2: talazoparib 1 mg SC daily	Advanced solid tumors treated previously with 1–3 platinum-based CTH	1. AEs 2. CBR (CR + PR + SD for >24 w)	NCT03426254 Active, not recruiting

AEs adverse events, ATM ataxia-telangiectasia mutated gene, BC breast cancer, BRCA breast cancer susceptibility genes, CBR clinical benefit rate, CR complete response, CRPC castration-resistant prostate cancer, CTH chemotherapy, EOC epithelial ovarian cancer, NSCLC non-small-cell lung cancer, ORR objective response rate, OS overall survival, PFS progression-free survival, PO per os (oral), PR partial response, RP2D recommended phase II dose, SC subcutaneous, SCLC small cell lung cancer, SD stable disease, TNBC triple-negative breast cancer, wk weeks