Last updated on May 2019

A Phase 1 Study Of Talazoparib PARP Inhibitor In Japanese Patients With Advanced Solid Tumors


Brief description of study

This is a Phase 1 study which consists of 2 parts; Dose Escalation part and Expansion part.

The dose escalation part is openlabel, and evaluates safety, preliminary efficacy and PK of singleagent 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.

Clinical Study Identifier: NCT03343054

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Recruitment Status: Open


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