A Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Advanced/Metastatic RCC Patients

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).

Timeline

Start

2012-11-30

Primary completion

2015-03-19

Completion

2017-02-21

Drugs

Indications