NCT01908322

Brief Summary

The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 11, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

July 23, 2013

Last Update Submit

November 10, 2015

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinomaIntermediate stageObservational study

Outcome Measures

Primary Outcomes (2)

  • Distribution of intermediate stage hepatocellular carcinoma (HCC) patients treated with Nexavar to different treatment groups will be evaluated by the relative frequency of patients in each treatment group.

    up to 54 months

  • Characteristics of patients with intermediate stage HCC (BCLC-B) treated with Nexavar will be determined by evaluating demographic data, medical history, previous treatment of HCC, specific concomitant conditions (amongst others).

    up to 54 months

Secondary Outcomes (8)

  • Overall Survival is measured as the time interval from start of Nexavar therapy to the date of death, due to any reason.

    up to 54 months

  • Time to progression is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression.

    up to 54 months

  • Progression free survival is measured as the time interval from the start of Nexavar treatment to diagnosed (radiological or clinical) progression or death, whichever comes first.

    up to 54 months

  • Time to treatment failure is defined as the time interval from start of Nexavar therapy to the date of diagnosed progression or permanent discontinuation due to toxicity.

    up to 54 months

  • Duration of Nexavar treatment is measured as the time interval from start of Nexavar therapy to the date of permanent discontinuation of Nexavar therapy (regardless of the reason for discontinuation).

    up to 54 months

  • +3 more secondary outcomes

Study Arms (1)

Group 1

Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Sorafenib (Nexavar, BAY43-9006)DRUG

Patients will be followed-up from start of Nexavar therapy until death or drop out due to any reason or end of study

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of patients with intermediate stage hepatocellular carcinoma (BCLC-B) treated with Nexavar according to the local summary of product characteristics. Participants will be recruited from oncological and gastroenterological clinics and practices throughout Germany. In this non-interventional observational study, the decision on the duration and dosage of treatment is solely at the discretion of the attending physician. The medication is prescribed at regular visits to the investigator's office. Commercially available product will be used to treat the patients.

You may qualify if:

  • Patients with a diagnosis of unresectable intermediate stage hepatocellular carcinoma (BCLC-B) for whom the decision has been taken by the investigator to prescribe Nexavar (the BCLC intermediate stage (BCLC-B) consists of Child-Pugh A and B patients with large/multifocal HCC who do not have cancer related symptoms, macrovascular invasion or extrahepatic spread).

You may not qualify if:

  • \- Prior targeted therapy for hepatocellular carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

July 23, 2013

First Posted

July 25, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2015

Study Completion

September 1, 2015

Last Updated

November 11, 2015

Record last verified: 2015-11

Locations

DE(1)