A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044512
• Other study ID #: 10874
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2002
• Last updated: March 26, 2014
• Start date: August 2002
• Est. completion date: February 2008

Study information

• Verified date: March 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

• Pharmacokinetics (PK) profile of Sorafenib

• Plasma and tissue tumor biomarkers

Other known NCT identifiers

• NCT00048919
• NCT00058383

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  France,  Israel,  Italy, 

References & Publications (2)

Abou-Alfa GK, Amadori D, Santoro A, Figer A, De Greve J, Lathia C, Voliotis D, Anderson S, Moscovici M, Ricci S. Safety and Efficacy of Sorafenib in Patients with Hepatocellular Carcinoma (HCC) and Child-Pugh A versus B Cirrhosis. Gastrointest Cancer Res. — View Citation

Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants for Each Type of Response	Objective response rate of sorafenib assessed as the proportion of subjects with confirmed complete or partial response as per modified World Health Organization (WHO) criteria.	Until 30 days after termination of active therapy	No
Secondary	Duration of Response	Duration of response was calculated from the first drug treatment date until documented progressive disease (PD). PD was 1) 25% or more increase in the sum of all target lesion areas taking as reference the smallest sum recorded at or following baseline, 2) unequivocal progression of an existing non-target lesion, or 3) appearance of a new lesion.	up to 3 years later	No
Secondary	Time to Response	Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).	up to 3 years later	No
Secondary	Time to Progression	Time from the first date of receiving study drug until the first documented PD.	up to 3 years later	No
Secondary	Duration of Stable Disease	Time from the first day of receiving study drug until there was a documented PD or response.	up to 3 years later	No
Secondary	Time to Minor Response	Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.	up to 3 years later	No
Secondary	Duration of Minor Response	Time from the date that MR was first documented to the date that PD was first documented.	Time from MR to PD	No
Secondary	Overall Survival	Time from the first date of receiving study medication to death.	Start of treatment to death	No

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