NCT01831973

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Taiwan Liposome Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Advanced/Metastasis Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Lipotecan

Timeline

• Start date: 2012-11-30
• Primary completion: 2015-03-19
• Completion: 2017-02-21
• First posted: 2013-04-15
• Last updated: 2018-06-26

Locations

5 sites across 1 country: Taiwan