A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma - Tabular View

Tracking Information

First Received Date ^ICMJE

August 30, 2002

Last Updated Date

June 19, 2009

Start Date ^ICMJE

August 2002

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective Response Rate [ Time Frame: Until 30 days after termination of active therapy ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To evaluate the anti-cancer activity (e.g. proportion of patients with confirmed complete responses and partial responses as per the WHO criteria) in patients with advanced inoperable biopsy-proven hepatocellular carcinoma [ Time Frame: Tumor response measurements will be made at baseline and every 8 weeks, within the last 10 days of each dual cycle during the treatment period, according to WHO criteria. ]

Change History

Complete list of historical versions of study NCT00044512 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Duration of Response [ Time Frame: Time from first dose of study drug until disease progression ] [ Designated as safety issue: No ]
Time to Response [ Time Frame: Until objective response occurs ] [ Designated as safety issue: No ]
Time to Progression [ Time Frame: Until progression occurs ] [ Designated as safety issue: No ]
Duration of Stable Disease [ Time Frame: Until documented PD or response. ] [ Designated as safety issue: No ]
Time to Minor Response [ Time Frame: Until MR was first documented ] [ Designated as safety issue: No ]
Duration of Minor Response [ Time Frame: Time from MR to PD ] [ Designated as safety issue: No ]
Overall Survival [ Time Frame: Start of treatment to death ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To determine duration of response, time to response, time to progression, duration of stable disease and survival. To evaluate proportion of patients with stable disease. [ Time Frame: see below ]
To determine the toxicities of this treatment regimen in this patient population. [ Time Frame: see below ]
Pharmacokinetic profiles of sorafenib will be determined in approximately 20-23 patients enrolled in selected sites, to receive all requested plasma samples from 16 patients with valid pharmacokinetic data. [ Time Frame: see below ]
PK will be measured on the first day of the second cycle (one day prior or after is allowed), and if not possible, any later date is acceptable). [ Time Frame: see below ]
To evaluate pERK concentration in the original tumor biopsy, when possible, and correlate it with measures of clinical benefit (e.g. response, time to progression and survival). [ Time Frame: see below ]
To evaluate the relationship between the presences of serum HER-2 elevation and/or plasma adrenomedullin elevation with measures of clinical benefit (e.g. response, time to progression and survival). [ Time Frame: see below ]
To evaluate change in α-fetoprotein in treated patients. [ Time Frame: see below ]
To define a pattern of serum proteins that, when present in patients prior to treatment, appears to correlate with sorafenib-related clinical benefit (e.g. response, time to progression and/or survival). [ Time Frame: see below ]
To measure baseline cell RNA expression in patients with HCC and correlate it with sorafenib-related clinical benefit (e.g. response, time to progression and/or survival) [ Time Frame: see below ]

Descriptive Information

Brief Title ^ICMJE

A Study to Estimate Safety and Efficacy of Bay 43-9006 in the Treatment of Hepatocellular Carcinoma

Official Title ^ICMJE

A Phase II Multicenter Uncontrolled Trial of BAY 43-9006 in Patients With Advanced Hepatocellular Carcinoma

Brief Summary

Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

Detailed Description

In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:

PK profile of Sorafenib
Plasma and tissue tumor biomarkers

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Carcinoma, Hepatocellular

Intervention ^ICMJE

Drug: Nexavar (Sorafenib, BAY43-9006)

Study Arms / Comparison Groups

Experimental: Sorafenib (BAY 43-9006) 400 mg administered b.i.d.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

137

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
Measurable disease
At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
Presence of at least 1 of the following:
Alpha-fetoprotein greater than the upper limit of normal (ULN)
Hepatitis C antibody positive
Hepatitis B surface antigen positive
Child's Pugh class A or B
Candidate for systemic therapy

Exclusion Criteria:

Fibrolamellar disease mixed histology
Metastatic brain or meningeal tumors

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Belgium, France, Israel, Italy

Administrative Information

NCT ID ^ICMJE

NCT00044512

Responsible Party

Therapeutic Area Head, Bayer HealtCare Pharmaceuticals

Study ID Numbers ^ICMJE

10874

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP