Dose Escalation of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

September 1, 2010 updated by: Istituto Clinico Humanitas

Randomized Continuation, Dose Escalation Trial of Sorafenib in Patients With Advanced HCC With Radiological Progression on Prior Sorafenib Treatment (Phase II Study)

The aim of the study is to evaluate, after radiological progression, efficacy in patients treated with Sorafenib at a dose of 600 mg bid compared to that in patients treated with best supportive care.

Primary efficacy objective is progression free survival from randomization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with advanced/inoperable HCC not eligible for radical or loco-regional therapies Male or female patients ≥ 18 years of age Life expectancy of at least 12 weeks at screening Histologically or cytologically documented HCC

At least one tumor lesion that meets both of the following criteria:

  1. The lesion is measurable as per RECIST criteria, and
  2. The lesion has not been subject to previous loco-regional therapy (such as radiation therapy, TACE, TAE, PEI, RFA, or cryoablation) Patients previously treated with loco-regional treatments are eligible provided that previously treated lesions are not selected as target lesions. Local therapy must be completed at least 4 weeks prior to the baseline scan ECOG PS of 0, 1, or 2 Cirrhotic status of Child-Pugh class A or B Barcelona-Clinic Liver Cancer (BCLC) stage B or C

The following laboratory parameters:

  • Platelet count ≥ 60 x 109 /L
  • Haemoglobin ≥ 8,5 g/dL
  • Total bilirubin ≤ 3 mg/dL
  • Alanine transaminase (ALT) and Aspartato transaminase (AST) ≤ 5 x upper limit of normal
  • Amylase and lipase < 1,5 x the upper limit of normal
  • Serum creatinine ≤ 1,5 x the upper limit of normal
  • Prothrombin time (PT)-international normalized ratio (INR) < 2,3 or PT < 0,6 seconds above control. Patients who are being therapeutically anticoagulated with an agent such as Coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.

Written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.

Exclusion Criteria:

  • Previous or concurrent cancer that is distinct in primary site or histology from HCC, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1).
  • Any cancer curatively treated > 3 years prior to entry is permitted Renal failure requiring hemo- or peritoneal dialysis
  • History of cardiac disease: congestive heart failure > New York Heart Association (NYHA) class 2;
  • active coronary artery disease (CAD);
  • cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers ordigoxin), or uncontrolled hypertension.
  • Myocardial infarction more than 6 months prior to study entry is permitted if there is no evidence of active CAD
  • Active clinically serious infections (> Grade 2 [NCI CTCAE] )
  • Known history of human immunodeficiency virus (HIV) infection
  • Known Central Nervous System tumors including metastatic brain disease
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry
  • History of organ allograft
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
  • Patients unable to swallow oral medications
  • Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug.
  • Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

June 22, 2007

First Submitted That Met QC Criteria

June 22, 2007

First Posted (Estimate)

June 25, 2007

Study Record Updates

Last Update Posted (Estimate)

September 2, 2010

Last Update Submitted That Met QC Criteria

September 1, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-2006-004
  • EUDRACT 2007-000758-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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