SU011248 for Platinum-Refractory Urothelial Cancer Evaluation Trial

• Status: Completed
• Trial end date: 2014-07-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AHS Cancer Control Alberta; Alberta Health Services
• Collaborator: Pfizer
• Treatments: Sunitinib

Criteria

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