Clinical Trial: Study of Regorafenib for Urothelial Cancer Following Chemotherapy (UAB 1477)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Multicenter, Non-Randomized, Phase II Study of Regorafenib for Advanced Urothelial Cancer Following Prior Chemotherapy

Brief 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.

Detailed Summary:

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.


Sponsor: University of Alabama at Birmingham

Current Primary Outcome: Progression-free survival [ Time Frame: Baseline to 6 months following end of study ]

Progression-free survival is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease response rate [ Time Frame: Every 8 weeks until the time of disease progression ]
    Tumor measurements will be documented through CT scans, magnetic resonance imaging (MRI), and x-rays using the Response Evaluation Criteria in Solid Tumors (RECIST).
  • Overall survival [ Time Frame: Baseline to 3 years ]
    Length of subject survival after starting study treatment
  • Rate of progression-free survival at 6 months (PFS6) [ Time Frame: 6 months following the last cycle of treatment ]
  • Number of Participants with Adverse Events [ Time Frame: At the end of first treatment until 6 months following last treatment, an expected average of 10 months ]
    The Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 will be used for assessment of toxicities.


Original Secondary Outcome: Same as current

Information By: University of Alabama at Birmingham

Dates:
Date Received: May 26, 2015
Date Started: May 2015
Date Completion:
Last Updated: January 4, 2017
Last Verified: January 2017