NCT00792350

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
791

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

5.5 years

First QC Date

November 14, 2008

Last Update Submit

May 13, 2014

Conditions

Carcinoma, Hepatocellular

Keywords

Carcinoma, HepatocellularSorafenib

Outcome Measures

Primary Outcomes (1)

  • Efficacy: status of tumor, patients performance status

    At each follow-up visit, every 2-4 months

Secondary Outcomes (3)

  • Duration of treatment

    At each follow-up visit, every 2-4 months

  • Time of survival

    At each follow-up visit, every 2-4 months

  • Reports of adverse events

    At each follow-up visit, every 2-4 months

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea CompoundsUreaAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNiacinamideNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 17, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2013

Study Completion

April 1, 2014

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations

AU(1)DE(1)