A Phase I trial of talazoparib in patients with advanced hematologic malignancies.

International Journal of Hematologic Oncology Pub Date : 2021-10-22 eCollection Date: 2021-09-01 DOI:10.2217/ijh-2021-0004

Ajay K Gopal, Rakesh Popat, Ryan J Mattison, Tobias Menne, Adrian Bloor, Terry Gaymes, Asim Khwaja, Mark Juckett, Ying Chen, Matthew J Cotter, Ghulam J Mufti

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引用次数: 1

Abstract

Aim: The objective of this study was to establish the maximum tolerated dose (MTD), safety, pharmacokinetics, and anti-leukemic activity of talazoparib.

Patients & methods: This Phase I, two-cohort, dose-escalation trial evaluated talazoparib monotherapy in advanced hematologic malignancies (cohort 1: acute myeloid leukemia/myelodysplastic syndrome; cohort 2: chronic lymphocytic leukemia/mantle cell lymphoma).

Results: Thirty-three (cohort 1: n = 25; cohort 2: n = 8) patients received talazoparib (0.1-2.0 mg once daily). The MTD was exceeded at 2.0 mg/day in cohort 1 and at 0.9 mg/day in cohort 2. Grade ≥3 adverse events were primarily hematologic. Eighteen (54.5%) patients reported stable disease.

Conclusion: Talazoparib is relatively well tolerated in hematologic malignancies, with a similar MTD as in solid tumors, and shows preliminary anti leukemic activity.Clinical trial registration: NCT01399840 (ClinicalTrials.gov).

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talazoparib在晚期血液恶性肿瘤患者中的I期临床试验。

目的:本研究的目的是建立最大耐受剂量(MTD)，安全性，药代动力学和抗白血病活性的塔拉唑帕尼。患者和方法:这项I期、双队列、剂量递增试验评估了talazoparib单药治疗晚期血液系统恶性肿瘤(队列1:急性髓系白血病/骨髓增生异常综合征;队列2:慢性淋巴细胞白血病/套细胞淋巴瘤)。结果:33人(队列1:n = 25;队列2:n = 8例患者接受talazoparib治疗(0.1-2.0 mg，每日1次)。在队列1中，MTD超过2.0 mg/天，在队列2中超过0.9 mg/天。≥3级不良事件主要是血液学方面的。18例(54.5%)患者病情稳定。结论:Talazoparib在血液恶性肿瘤中具有较好的耐受性，MTD与实体瘤相似，并具有初步的抗白血病活性。临床试验注册:NCT01399840 (ClinicalTrials.gov)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

International Journal of Hematologic Oncology

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审稿时长

13 weeks

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