A Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Advanced/Metastatic RCC Patients
Status:
Completed
Trial end date:
2017-02-21
Target enrollment:
Participant gender:
Summary
INVESTIGATIONAL PRODUCT:
TLC388 (Lipotecan*) *Lipotecan is a drug product of TLC388 HCl.
PHASE OF DEVELOPMENT:
Phase II
No. OF PATIENTS:
Approximately 40 (Stage I: 15 evaluable patients, Stage II: 25 evaluable patients)
STUDY OBJECTIVES:
Primary
• To evaluate non-progression disease (non-PD) rate at the end of cycle 6
Secondary
- To evaluate progression free survival (PFS)
- To evaluate overall survival (OS)
- To evaluate the duration of non-PD
- To evaluate objective response rate (ORR; where ORR= CR+PR) and duration
- To evaluate the safety profile of TLC388
- To evaluate change in health-related quality of life (HRQOL) at the end of cycle 6
STUDY DESIGN:
This is a Phase II, open-label, single-arm, multi-centre study to evaluate TLC388 monotherapy
in patients with locally advanced and/or metastatic renal cell carcinoma (RCC).