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

Conditions

• Neuroendocrine Carcinomas

Interventions

DRUG

TLC 388

40 mg/m2 of TLC 388, given as a 30 (+3) minute intravenous infusion, on Days 1, 8 and 15 of a 28-day cycle until PD, unacceptable toxicity or consent withdrawal occurs.

Sponsors & Collaborators

• National Taiwan University Hospital

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• Taichung Veterans General Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Chang Gung Memorial Hospital

  collaborator OTHER

• Kaohsiung Medical University Chung-Ho Memorial Hospital

  collaborator OTHER

• National Health Research Institutes, Taiwan

  lead OTHER

Principal Investigators

• Yee Chao, MD., PhD · Taipei Veterans General Hospital, Taiwan

• Hui-Jen Tsai, MD., PhD · National Health Research of Institutes

• Ming-Huang Chen, MD., PhD · Taipei Veterans General Hospital, Taiwan

• Jen-Shi Chen, MD · Chang Gung Memorial Hospital

• Cheng-Chung Wu, MS · Taichung Veterans General Hospital

• Chiun Hsu, MD., PhD · National Taiwan University Hospital

• Chia-Jui Yen, MD., PhD · National Cheng-Kung University Hospital

• Yen-Yang Chen, MD · Chang Gung Memorial Hospital

• Ta-Chih Liu, MD., PhD · Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-04

Primary Completion

2018-04-18

Completion

2018-12-01

FDA Drug

Yes

Countries

• Taiwan

Study Locations