SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

Phase 2

Completed

• Conditions: Urothelial Cancer; Bladder Cancer; Adult
• Interventions: Drug: SU011248; Drug: Placebo

• Registration Number: NCT00578526
• Lead Sponsor: AHS Cancer Control Alberta

Brief 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

Study Timeline

• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Study Start: 2008-04
• Primary Completion: 2014-07-16
• Study Completion: 2014-07-16
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Histologically/cytologically proven inoperable, metastatic or recurrent transitional cell carcinoma of the urothelial tract
• Mixed histology with predominant TCC allowed.
• Failed, intolerant or ineligible for cisplatin based chemo
• Measurable Disease (RECIST)Not previously irradiated.
• Recovered from previous acute treatment to grade 1(CTCAE Vers. 3.0)
• No weight loss >/- 10% within 28 days of day 0
• Adequate Organ Function

Exclusion Criteria

• Adenocarcinoma, squamous carcinoma or other histology without any components of transitional carcinoma.
• Small cell histology
• More than one previous systemic chemo
• Excised metastases without remaining measureable disease
• Prior therapy with angiogenesis inhibitors

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	SU011248	SU011248 - 4 weeks on followed by 2 weeks rest period every 6 weeks
Arm 2	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	4 months

Secondary Outcome Measures

Name	Time	Method
Change in health-related quality of life	Study Duration
Number of participants that develop an adverse event to treatment.	Study Duration
Overall Survival	Study Duration
objective response rate	Study Duration
duration of response	study duration

Trial Locations

Locations (5)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

British Columbia Cancer Agency - Vancouver Centre; 🇨🇦 Vancouver, British Columbia, Canada