check_circleStudy Completed
Carcinoma, Hepatocellular
Bayer Identifier:
14690
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
INSIGHT - Post Marketing Surveillance
Trial purpose
In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
791Trial Dates
April 2008 - April 2014Phase
N/ACould I Receive a placebo
NoProducts
Nexavar (Sorafenib, BAY43-9006)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany | |
Completed | Many Locations, Austria |
Primary Outcome
- Efficacy: status of tumor, patients performance statusdate_rangeTime Frame:At each follow-up visit, every 2-4 monthsenhanced_encryptionnoSafety Issue:
Secondary Outcome
- Duration of treatmentdate_rangeTime Frame:At each follow-up visit, every 2-4 monthsenhanced_encryptionnoSafety Issue:
- Time of survivaldate_rangeTime Frame:At each follow-up visit, every 2-4 monthsenhanced_encryptionnoSafety Issue:
- Reports of adverse eventsdate_rangeTime Frame:At each follow-up visit, every 2-4 monthsenhanced_encryptionyesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A