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OpenTrials
Completed

NCT Number: NCT00792350

INSIGHT - Post Marketing Surveillance

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar

Exclusion criteria

  • Exclusion criteria must be read in conjunction with the local product information

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Primary outcomes

  1. Efficacy: status of tumor, patients performance status

    Time frame: At each follow-up visit, every 2-4 months

Secondary outcomes

  1. Duration of treatment

    Time frame: At each follow-up visit, every 2-4 months

  2. Time of survival

    Time frame: At each follow-up visit, every 2-4 months

  3. Reports of adverse events

    Time frame: At each follow-up visit, every 2-4 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)

Acronym: INSIGHT

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Nov 17, 2008
Registry last updated
May 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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