Phase II Study to Evaluate the Efficacy and Safety of TLC388 for Differentiated Neuroendocrine Carcinomas Patients
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
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
Phase:
Phase 2
Details
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
Chang Gung Memorial Hospital Kaohsiung Medical University Chung-Ho Memorial Hospital National Cheng-Kung University Hospital National Taiwan University Hospital Taichung Veterans General Hospital Taipei Veterans General Hospital, Taiwan