Advanced/Metastasis Renal Cell Carcinoma Clinical Trial
Official title:
An Open-Label, Single-Arm, Multi-center Phase II Study to Evaluate the Efficacy and Safety of TLC388 in Patients With Advanced/Metastatic Renal Cell Carcinoma
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).
A Phase II, open-label, single-arm, multi-center study to evaluate TLC388 monotherapy in
patients with locally advanced and/or metastatic RCC. The study consisted of a
Screening/Baseline Period, a Treatment Period and a post-treatment Follow-Up Period for PFS
and OS.
Patients were to be recruited at two stages. Stage I recruited 15 evaluable patients, who had
completed at least 2 cycles of treatment with one tumor assessment. If ≤ 5 patients did not
develop PD at the end of cycle 6 per RECIST, no patients were to be recruited for Stage II
and the study was to be closed. If > 5 patients did not develop PD at the end of cycle 6, a
total of 40 evaluable patients (additional 25 evaluable patients for Stage II) were to be
recruited thereafter.
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