Phase II Study to Evaluate the Efficacy and Safety of TLC388 for Differentiated Neuroendocrine Carcinomas Patients

Summary

Title of Study: An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of TLC388 as Second-line Treatment in Subjects with Poorly Differentiated Neuroendocrine Carcinomas Investigational product: Lipotecan®\* \*Lipotecan® is the trade name of TLC388 HCl, a Topoisomerase I inhibitor) Phase of development: Phase II Number of subjects: Plan to enroll 44 subjects Objectives: Primary objectives: To determine the objective response rate Secondary objectives: To evaluate Disease control rate, Progression free survival, Overall survival, Safety profile and Biomarkers

Timeline

Start

2015-07-04

Primary completion

2018-04-18

Completion

2018-12-01

Publications

• Chen MH, Chou WC, Hsiao CF, Jiang SS, Tsai HJ, Liu YC, Hsu C, Shan YS, Hung YP, Hsich CH, Chiu CH, Liu TC, Cho SF, Liu TW, Chao Y. An Open-Label, Single-Arm, Two-Stage, Multicenter, Phase II Study to Evaluate the Efficacy of TLC388 and Genomic Analysis for Poorly Differentiated Neuroendocrine Carcinomas. Oncologist. 2020 May;25(5):e782-e788. doi: 10.1634/theoncologist.2019-0490. Epub 2019 Dec 18.

Drugs

Indications