check_circleStudy Completed

Carcinoma, Hepatocellular

Bayer Identifier:

10874

ClinicalTrials.gov Identifier:

NCT00044512

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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
  • - Fibrolamellar disease mixed histology
    - Metastatic brain or meningeal tumors

Trial summary

Enrollment Goal
137
Trial Dates
August 2002 - February 2008
Phase
Phase 2
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Hôpital de la Timone - MarseilleMARSEILLE, 13005, France
Completed
A.O.U. PisanaPisa, 56126, Italy
Completed
Hadassah University Hospital Ein KeremJerusalem, 91120, Israel
Completed
Centre Eugène Marquis - Rennes CedexRENNES CEDEX, 35062, France
Completed
Ospedale Borgo TrentoVerona, 37126, Italy
Completed
Centre Oscar Lambret - LilleLILLE CEDEX, 59020, France
Completed
IRCCS Osp Maggiore PoliclinicoMilano, 20122, Italy
Completed
Institut Jules Bordet/Jules Bordet InstituutBRUXELLES - BRUSSEL, 1000, Belgium
Completed
Centre René Gauducheau - NantesSAINT HERBLAIN, 44805, France
Completed
Tel Aviv Sourasky Medical CenterTel Aviv, 64239, Israel
Completed
AUSL Forlì - Emilia RomagnaForlì, 47100, Italy
Completed
Memorial Sloan-Kettering Cancer CenterNew York, 10021-6007, United States
Completed
UZ GentGENT, 9000, Belgium
Completed
Kaplan Medical CenterRehovot, 76100, Israel
Completed
Metropolitan Hematology Oncology Medical GroupLos Angeles, 90057, United States
Completed
Hôpital Erasme/Erasmus ZiekenhuisBRUXELLES - BRUSSEL, 1070, Belgium
Completed
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
Chaim Sheba Medical CenterTel Hashomer, 52621, Israel
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
Hôpital Tenon - ParisPARIS, 75020, France
Completed
Rabin Medical Center - Beilinson CampusPetach Tikva, 49100, Israel
Completed
IRCCS Ist Clinico HumanitasRozzano, 20089, Italy
Completed
Rambam Medical CenterHaifa, 31096, Israel

Primary Outcome

  • Percentage of Participants for Each Type of Response
    date_rangeTime Frame:
    Until 30 days after termination of active therapy
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Duration of Response
    date_rangeTime Frame:
    up to 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Time to Response
    date_rangeTime Frame:
    up to 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Time to Progression
    date_rangeTime Frame:
    up to 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Stable Disease
    date_rangeTime Frame:
    up to 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Time to Minor Response
    date_rangeTime Frame:
    up to 3 years later
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Minor Response
    date_rangeTime Frame:
    Time from MR to PD
    enhanced_encryption
    Safety Issue:
    No
  • Overall Survival
    date_rangeTime Frame:
    Start of treatment to death
    enhanced_encryption
    Safety Issue:
    No

Trial design

A phase II multicenter uncontrolled trial of Sorafenib (BAY43-9006) in patients with advanced Hepatocellular Carcinoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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