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 Talazoparib Tosylate , BMN-673, MDV3800
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

ORR, DCR, PFS, RP2D, evaluated per RECIST or CA125

Biomarkers

gBRCA1/2 MUT

Efficacy

RP2D: Tal 1mg qd
ORR: 41.7% (1CR, 4PR, n=12)
DCR (6 months): 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