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

Phase 2

Completed

• Conditions: Advanced/Metastasis Renal Cell Carcinoma
• Interventions: Drug: Lipotecan

• Registration Number: NCT01831973
• Lead Sponsor: Taiwan Liposome Company

Brief 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.

Study Timeline

• Study Start: 2012-11-30
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-04-10
• Study First Posted: 2013-04-15
• Primary Completion: 2015-03-19
• Study Completion: 2017-02-21
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-21
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lipotecan, injection for chemotherapy	Lipotecan	Patients receive TLC388 (50 mg/m2) given as a 30-minute IV infusion, on Days 1, 8, and 15 of a 28-day cycle.

Primary Outcome Measures

Name	Time	Method
Non-progression disease (non-PD) rate at the end of cycle 6	6 months	Non-progression disease rate after cycle 6

Secondary Outcome Measures

Name	Time	Method
Change in health-related quality of life (HRQOL) at the end of cycle 6	6 months	Quality of life after cycle 6
Progression free survival (PFS)	3 years	Progression free survival
Overall survival (OS)	3 years	Overall sruvival
Safety profile of TLC388	3 years	Serious/ Adverse Events
Objective response rate (ORR; where ORR= CR+PR) and duration	3 years	Objective response rate and duration
Duration of non-PD	3 years	Non-progression disease rate (overall)

Trial Locations

Locations (5)

Chang Gung Memorial Hospital. Kaohsiung Branch; 🇨🇳 Kaohsiung, Taiwan

Chang Gung Memorial Hospital: LinKou Branch; 🇨🇳 Taoyuan, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan