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一项多中心、开放标签的1期研究，评估培门冬酶联合吉西他滨用于晚期转移性实体瘤和淋巴瘤的安全性和耐受性。

A multicenter, open-label, Phase 1 study evaluating the safety and tolerability of pegaspargase in combination with gemcitabine in advanced metastatic solid tumors and lymphoma.

作者信息

Borad Mitesh J, Babiker Hani M, Anthony Stephen, Mita Monica, Buchbinder Aby, Keilani Taha, Grem Jean

机构信息

1Division of Hematology and Oncology, Mayo Clinic , Scottsdale, Arizona , USA.

出版信息

Cancer Invest. 2015 May;33(5):172-9. doi: 10.3109/07357907.2015.1019677. Epub 2015 Apr 6.

DOI:10.3109/07357907.2015.1019677
PMID:25844818
Abstract

PURPOSE

To evaluate the maximum tolerated dose, safety profile, pharmacokinetics, and pharmacodynamics of pegaspargase (PEG-ASP) in combination with gemcitabine in patients with advanced metastatic solid tumors and lymphoma.

METHODS

We conducted a multicenter, open label, nonrandomized, Phase 1 dose escalation study designed to evaluate up to 10 cohorts of patients with advanced or metastatic solid tumors and lymphoma. Seventeen patients were treated with of PEG-ASP in combination with gemcitabine.

RESULTS

The study was terminated early because the doses for PEG-ASP suggested for de-escalation were predicted not to provide desired sustained asparaginase concentrations based on the analysis of treated patients.

摘要

目的

评估培门冬酶（PEG-ASP）联合吉西他滨用于晚期转移性实体瘤和淋巴瘤患者的最大耐受剂量、安全性、药代动力学及药效学。

方法

我们开展了一项多中心、开放标签、非随机的1期剂量递增研究，旨在评估多达10组晚期或转移性实体瘤及淋巴瘤患者。17例患者接受了PEG-ASP联合吉西他滨治疗。

结果

该研究提前终止，原因是根据对已治疗患者的分析，预计降低剂量的PEG-ASP无法提供所需的持续天冬酰胺酶浓度。

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