Clinical Trials Directory

Trials / Completed

CompletedNCT00578526

SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

A Randomized, Placebo-controlled Phase II Study to Compare the Efficacy and Safety of SU011248 Versus Placebo in Patients With Advanced Urothelial Transitional Cell Carcinoma Who Have Failed or Are Intolerant to Cisplatin-based Chemotherapy

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
64 (actual)
Sponsor
AHS Cancer Control Alberta · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.

Detailed description

The study objectives include the determination of the antitumor effect of SU011248 in patients with urothelial transitional cell carcinoma and to also determine the toxicities and tolerability of SU011248 in patients with urothelial transitional cell carcinoma who have failed or are intolerant to cisplatin-based chemotherapy. The primary endpoint of the study is to compare progression free survival at 4 months in patients who received SU011248 plus BSC versus patients who received placebo plus BSC The secondary endpoint is to compare the objective response rate and duration of response in patients who received SU011248 plus BSC versus patients who received placebo plus BSC, to describe the QOL and safety profile of SU011248 when compared to placebo and to describe the overall survival in patients who received SU011248 plus BSC versus patients who received placebo plus BSC

Conditions

Interventions

TypeNameDescription
DRUGSU01124850 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
DRUGPlacebo50 mg capsule OD PO for 28 days then 14 days rest until disease progression

Timeline

Start date
2008-04-01
Primary completion
2014-07-16
Completion
2014-07-16
First posted
2007-12-21
Last updated
2018-08-22

Locations

5 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT00578526. Inclusion in this directory is not an endorsement.