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Clinical Trial Summary

This study will test how well Regorafenib controls disease progression in urothelial cancer (cancer occurring in the urinary bladder, ureters, or renal pelvis) following previous therapy with chemotherapy.


Clinical Trial Description

Advanced urothelial carcinoma (UC) has a poor long-term prognosis. The disease has not seen improved outcomes despite research efforts in over two decades. Novel therapeutic options are needed. Regorafenib is a novel oral multikinase inhibitor but is more potent than a similar multikinase inhibitor drug that treats advanced renal cell carcinoma and hepatocellular carcinoma. Regorafenib has been shown to have a broader capacity to inhibit blood supply to tumor sources.

This trial evaluates a proof-of-concept using Regorafenib in patients with metastatic progressive urothelial carcinoma following chemotherapy but still have a high level of activity performance in their daily living. The initial dose of Regorafenib will be 120 mg daily and then be escalated to 160 mg daily before gradually tapering. ;


Study Design


Related Conditions & MeSH terms

  • Pelvic Neoplasms
  • Urothelial Cancer (Urinary Bladder, Ureters, or Renal Pelvis Cancer)

NCT number NCT02459119
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Completed
Phase Phase 2
Start date May 2015
Completion date April 2020