Phase I study of liposomal irinotecan (LY01610) in patients with advanced esophageal squamous cell carcinoma.

ABSTRACT:

Purpose

This phase I trial was performed to determine the maximum-tolerated dose (MTD), dose-limiting toxicities (DLTs), preliminary efficacy, and pharmacokinetics (PK) of LY01610, a novel liposome-encapsulated irinotecan, in patients with advanced esophageal squamous cell carcinoma (ESCC).

Methods

This trial was conducted in two stages. In the dose-escalation stage, patients with advanced ESCC refractory or intolerant to previous chemotherapy received escalating doses of LY01610. A recommended dose based on patient tolerance was then expanded in the second stage. LY01610 was administered intravenously every 2 weeks, except that the first cycle in dose escalation was 3 weeks to allow observation of DLTs.

Results

Twenty-four patients were enrolled across 4 dose levels

SUBMITTER: Liu Y 

PROVIDER: S-EPMC8143070 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature