Clinical Trial: Observational Study to Determine the Effectiveness and Safety of Vismodegib in Patients With Locally Advanced Basal Cell Carcinoma (laBCC)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Non-Interventional Study to Investigate the Effectiveness, Safety and Utilization of Vismodegib on Locally Advanced Basal Cell Carcinoma Under Real World Conditions (NIELS)
Brief Summary: The primary purpose for this study is to evaluate the duration of response defined as duration from first documented response of complete response (CR) or partial response (PR) until disease progression (as determined by the treating physician) for laBCC patients.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Duration of Response [ Time Frame: Up to 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective Response Rate (ORR) (Rate of Patients With Complete Response (CR) or Partial Response (PR)) [ Time Frame: Up to 3 years ]
- Disease Control Rate (Complete Response (CR), Partial Response (PR) or Stable Disease (SD)) [ Time Frame: Up to 3 years ]
- Reccurence Rate: Rate of Patients Who Responded (CR or PR) and Later Progressed [ Time Frame: Up to 3 years ]
- Time to Progression (TTP) [ Time Frame: Up to 3 years ]
- Time to Death [ Time Frame: Up to 3 years ]
- Time to Response [ Time Frame: Up to 3 years ]
- Percentage of patients with Adverse Events, Including Adverse Events of Special Interest and Serious Adverse Events [ Time Frame: Up to 3 years ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: February 2, 2016
Date Started: September 2015
Date Completion: March 2019
Last Updated: September 1, 2016
Last Verified: September 2016
