A Phase 1, First In Human, Single-arm, Open-label Study Of Once A Day, Orally Administered Talazoparib (Bmn 673) In Patients With Advanced Or Recurrent Solid Tumors

Trial ID #	NCT01286987
Phase	I
Drug Class	DNA Damage Repair Pathway Inhibitors: PARP
Drug Name	Talazoparib
Alternate Drug Names	MDV3800, BMN-673, Talazoparib Tosylate , Talzenna
Drugs in Trial	Talazoparib
Eligible Participant	Solid tumors with germline BRCA mutations, no prior PARP inhibitor
Patients Enrolled	113 (25 ovarian)
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	CBR, ORR, PFS, RP2D, evaluated per RECIST or CA125
Biomarkers	gBRCA1/2 MUT
Efficacy	RP2D: Tal 1mg qd ORR: 41.7% (1CR, 4PR, n=12) CBR: 66.7% (1CR, 4PR, 3SD, n=12) PFS: 9.1 months (n=14) Exploratory analysis Pt status, doses 100ug and above: Pt-S (n=20): ORR: 55% Pt-R (n=5): ORR: 20%
Clinically Significant Adverse Events	Dose Limiting Toxicities: thrombocytopenia Serious AE: none Grade 3-4 AE: any (45%), anemia (23%), thrombocytopenia (18%), neutropenia (10%)
Conclusion	Promising activity in gBRCA MUT cancer
Reference	de Bono J et al. Phase I, Dose-Escalation, Two-Part Trial of the PARP Inhibitor Talazoparib in Patients with Advanced Germline BRCA1/2 Mutations and Selected Sporadic Cancers. Cancer Discov (2017) 7(6):620-629 https://www.ncbi.nlm.nih.gov/pubmed/28242752