Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: 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 Ne
Brief 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