進行性固形腫瘍を有する日本人患者を対象とした、PARP阻害剤タラゾパリブの第1相臨床試験

基本情報

NCT ID

NCT03343054

ステータス

完了

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

28

治験依頼者名

Pfizer

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (7)