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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00490685
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : September 2, 2010
Information provided by:
Istituto Clinico Humanitas

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Sorafenib (BAY-43-9006) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Continuation, Dose Escalation Trial of Sorafenib in Patients With Advanced HCC With Radiological Progression on Prior Sorafenib Treatment (Phase II Study)
Study Start Date : April 2007
Actual Primary Completion Date : June 2008

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U.S. FDA Resources

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00490685

Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas Identifier: NCT00490685     History of Changes
Other Study ID Numbers: ONC-2006-004
EUDRACT 2007-000758-30
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: August 2009

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs