Clinical trial NCT00044512: A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma
Official title: A Phase II Multicenter Uncontrolled Trial of Sorafenib (BAY43-9006) in Patients With Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Keywords: Cancer
Liver Cancer
Hepatocellular carcinoma (HCC)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2002-09-04
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

* Pharmacokinetics (PK) profile of Sorafenib
* Plasma and tissue tumor biomarkers

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants for Each Type of Response
timeFrame: Until 30 days after termination of active therapy
Secondary outcomes:
measure: Duration of Response
timeFrame: up to 3 years later
measure: Time to Response
timeFrame: up to 3 years later
measure: Time to Progression
timeFrame: up to 3 years later
measure: Duration of Stable Disease
timeFrame: up to 3 years later
measure: Time to Minor Response
timeFrame: up to 3 years later
measure: Duration of Minor Response
timeFrame: Time from MR to PD
measure: Overall Survival
timeFrame: Start of treatment to death
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: New York
country: United States
state: New York
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Lille Cedex
country: France
city: Marseille
country: France
city: Paris
country: France
city: Rennes Cedex
country: France
city: Saint Herblain
country: France
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Petach Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Rozzano
country: Italy
state: Milano
city: Forlì
country: Italy
city: Milano
country: Italy
city: Pisa
country: Italy
city: Verona
country: Italy
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.
citation: 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. 2011 Mar;4(2):40-4.