A Phase 2 interventional study of SU011248 and Placebo in Urothelial Cancer, Bladder Cancer and Adult, sponsored by AHS Cancer Control Alberta. Completed at 5 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-22.
Sponsored by AHS Cancer Control Alberta · Phase 2, Interventional, and Treatment
The purpose of this study is to find out if SU011248 works and if it is safe in patients with advanced transitional cell carcinoma.
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
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
Drug: SU011248
1 50 mg capsule OD PO for 4 weeks with 2 week rest until disease progression. Any patient with disease progression will be unblinded and patients on the placebo arm may then be considered for the open label Sutent treatment.
Drug: Placebo
50 mg capsule OD PO for 28 days followed by 14 days of rest until tumor progression
Also known as: Sutent, Sunitinib
50 mg capsule OD PO for 28 days then 14 days rest until disease progression
Progression Free Survival
Time frame: 4 months
objective response rate
Time frame: Study Duration
duration of response
Time frame: study duration
Change in health-related quality of life
Time frame: Study Duration
Number of participants that develop an adverse event to treatment.
Time frame: Study Duration
Overall Survival
Time frame: Study Duration
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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AHS Cancer Control Alberta