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Completed

NCT Number: NCT00044512

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

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.

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Key information

Conditions

Carcinoma, Hepatocellular Adenocarcinoma Carcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bruxelles - Brussel, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

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

Primary outcomes

  1. Percentage of Participants for Each Type of Response

    Time frame: Until 30 days after termination of active therapy

    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.

Secondary outcomes

  1. Duration of Response

    Time frame: up to 3 years later

    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.

  2. Time to Response

    Time frame: up to 3 years later

    Time from the first day of receiving study drug to the date the CR or PR was documented (with confirmation).

  3. Time to Progression

    Time frame: up to 3 years later

    Time from the first date of receiving study drug until the first documented PD.

  4. Duration of Stable Disease

    Time frame: up to 3 years later

    Time from the first day of receiving study drug until there was a documented PD or response.

  5. Time to Minor Response

    Time frame: up to 3 years later

    Time from the first day of receiving study drug to the date the MR was first documented (with confirmation). Minor response = >25% regression.

  6. Duration of Minor Response

    Time frame: Time from MR to PD

    Time from the date that MR was first documented to the date that PD was first documented.

  7. Overall Survival

    Time frame: Start of treatment to death

    Time from the first date of receiving study medication to death.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2008
Study completion
2008
First posted
Sep 4, 2002
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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