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

NCT01831973 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-06-26

No results posted yet for this study

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).

Conditions

  • Advanced/Metastasis Renal Cell Carcinoma

Interventions

DRUG

Lipotecan

Sponsors & Collaborators

  • Taiwan Liposome Company

    lead INDUSTRY

Principal Investigators

  • Dr. Yvonne Shi · Taiwan Liposome Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-03-19
Completion
2017-02-21

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01831973 on ClinicalTrials.gov