Oral formulation of bendamustine hydrochloride for patients with advanced solid tumors; a phase 1 study.

ABSTRACT: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of orally-administered bendamustine in Japanese patients with advanced solid tumors. The optimal dosing schedule, safety, pharmacokinetics, and preliminary antitumor effects were also evaluated. A multicenter, open-label trial with a standard 3 + 3 design and dose escalation by dose-limiting toxicity (DLT) was conducted. The treatment schedules were once daily for 7, 14, and 21 days every 3 weeks as one cycle. The total dose per cycle was increased from 175 to 840 mg/m². Eighteen patients were enrolled in this study. DLT occurred in one of six patients at 75 mg/m²/day × 7 days, and one of three patients at 37.5 mg/m²/day × 14 days and 25 mg/m²/day × 21 days. However, the dela

SUBMITTER: Shimizu T 

PROVIDER: S-EPMC10030450 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature