SyB C-0501(Oral Bendamustine) in Patients With Advanced Solid Tumors

Summary

This study is an open-label, multicenter, phase 1 study of SyB C-0501 by continuous daily oral administration in patients with advanced solid tumors, who have previously received anticancer therapy and consists of two parts. Part 1 is a dose escalation study to evaluate tolerability of SyB C-0501 in the patients, and to find the maximum tolerated dose (MTD), recommended dose (RD) and optimum dosing schedule. Part 2 is being done to evaluate safety and anti-tumor activity of SyB C-0501 preliminarily at RD, and to assess its target cancer exploratory.

Timeline

Start

2018-05-24

Primary completion

2020-09-11

Completion

2020-09-11

Publications

• Shimizu T, Nakagawa K, Hayashi H, Iwasa T, Kawakami H, Watanabe S, Yamamoto N, Yonemori K, Koyama T, Sato J, Tamura K, Kikuchi K, Akaike K, Takeda S, Takeda M. Oral formulation of bendamustine hydrochloride for patients with advanced solid tumors; a phase 1 study. Invest New Drugs. 2023 Feb;41(1):1-12. doi: 10.1007/s10637-022-01307-6. Epub 2022 Nov 4.

Drugs

Indications