Sorafenib in Hepatocellular Carcinoma Clinical Practice i... | NCT01539681

Studies
Sorafenib in Hepatocellular Carcinoma Clinical Practice in Italy

NCT01539681

Sponsor

Bayer

Status

Completed

Last Update Posted

Feb 18, 2016Estimated

Enrollment

234Actual

Phase

Not provided

Conditions

Hepatocellular Carcinoma

Interventions

Sorafenib (Nexavar, BAY43-9006)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NX1110IT	Other Identifier	company internal

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Feb 2015Actual

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Feb 22, 2012

First Posted Date

Feb 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2016

Last Update Posted Date

Feb 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, non-interventional, multi-center study. Patients affected by Hepatocellular Carcinoma (HCC) who are candidates for systemic therapy and in whom a decision to treat with sorafenib has been made. Aim of this non-interventional, post-marketing study is to evaluate the efficacy of sorafenib in terms of overall survival rate at 12 months in patients with HCC under daily-life treatment conditions.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

234Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Sorafenib (Nexavar, BAY43-9006)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib (Nexavar, BAY43-9006)	Drug	Subjects should be treated with sorafenib in compliance with the recommendations written in the local product information.However, the decision on the duration and dose of treatment is at the discretion of the prescribing physician.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy (analyzed by overall survival rate) of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.		at 1 year

Secondary Outcomes

Measure	Description	Time Frame
Adverse event collection of sorafenib under real-life practice conditions in patients with Hepatocellular Carcinoma.		every 4 months on average within approx. 2 years
Overall survival		at 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with histologically/cytologically confirmed HCC or radiographically diagnosed as per AASLD criteria, who are candidates for systemic therapy and for whom a decision to treat with sorafenib has been made
Patients must have signed the informed consent form
Patients must have a life expectancy of at least 8 weeks Inclusion criteria must follow the approved local product information.

Exclusion Criteria:

Prior treatment with sorafenib
Concomitant participation in other clinical studies Exclusion criteria must follow the approved local product information.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hepatocellular Carcinoma Patients treated in Italy

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077157	Sorafenib

Ancestor Terms

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided