Table 8. Phase II studies of talazoparib in ovarian cancer (www.clinicaltrials.gov).
Author, year of publication (reference) | Phase | Patients number | Description | Population | Outcome | Trial, status |
---|---|---|---|---|---|---|
(73) | II | 3 | Talazoparib 1 mg daily | 1. Recurrent and/or metastatic EOC | 1. Objective response (CR + PR) | NCT02326844 |
2. Progression on PARP inhibitors monotherapy | 2. Safety | Terminated (closed by the Cancer Therapy Evaluation Program) | ||||
3. gBRCAm | 3. Duration of response | |||||
4. PFS | ||||||
(74) | II | N/A | Arm 1: talazoparib 1 mg daily | 1. Recurrent EOC, primary peritoneal or fallopian tube cancer | ORR | NCT02836028 |
Arm 2: talazoparib 1 mg daily + temozolomide 37.5 mg/m2 on days 1–5 | 2. <3 prior lines of CTH | Withdrawn | ||||
3. gBRCAm, or sBRCAm, or HRD(+) |
EOC, epithelial ovarian cancer; PARP, poly(ADP-ribose) polymerase; BRCA, breast cancer gene; gBRCAm, germline BRCA mutation; CR, complete response; PR, partial response; PFS, progression-free survival; N/A, not available; CTH, chemotherapy; sBRCA, somatic BRCA mutation; HRD, homologous recombination deficiency; ORR, objective response rate.