A Phase 1 Study Of Talazoparib, PARP Inhibitor, In Japanese Patients With Advanced Solid Tumors
Status:
Active, not recruiting
Trial end date:
2022-07-01
Target enrollment:
Participant gender:
Summary
This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part.
The dose escalation part is open-label, and evaluates safety, preliminary efficacy and PK of
single-agent talazoparib in sequential cohorts of adult patients with advanced solid tumors
who are resistant to standard therapy or for whom no standard therapy is available.
In the dose escalation part, up to 18 (minimum 3) patients are expected to be enrolled
depending on the observed DLTs.
The expansion part is designed to assess the efficacy, safety and PK of single-agent
talazoparib at RP2D determined in the dose escalation part in adult patients with locally
advanced or metastatic breast cancer who have deleterious or suspected deleterious germline
BRCA1 or BRCA2 mutations.
In the expansion part, a minimum of 17 patients will be enrolled evaluable for the primary
endpoint.