Clinical trial NCT01337492 (early phase 1, status: terminated)
Conditions: carcinoma, hepatocellular
ICD codes: C22.0, C4A.9, C7B.1, C4A.0, C4A.31, C4A.51, C4A.8
Drugs: nexavar
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        Inclusion criteria:

          -  Age > 18 years old

          -  Confirmation of diagnosis of Hepato Cellular Carcinoma (HCC) and within Milan criteria
             awaiting liver transplant or going through evaluation for Liver Transplant.

          -  Either histological confirmation or clinical diagnosis by American Association for the
             Study of Liver Diseases(AASLD) criteria (see Appendix 1) in cirrhotic subjects is
             required. For subjects without cirrhosis histological confirmation is mandatory.

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

          -  Child Pugh A or B (Total point of 7 will be allowed See appendix for scoring system).
             (ONLY 4 patients with Child Pugh B7 will be allowed.)

          -  Adequate bone marrow, liver and renal function as assessed by the following:

          -  Hemoglobin > 8.5 g/dl

          -  Absolute neutrophil count (ANC) > 1,500/mm3

          -  Platelet count > 60,000/mm3

          -  Total bilirubin < 1.5 times Upper Limits of Normal (ULN)

          -  ALT and AST < 2.5 times the Upper Limits of Normal (ULN) ( < 5 x ULN for patients with
             liver involvement)

          -  Creatinine < 1.5 times Upper Limits of Normal (ULN)

          -  Women of childbearing potential must have 2 negative serum pregnancy test performed.
             The first test within 7-10 days prior to the start of treatment. The second test
             within 24 hours prior to start of treatment.

          -  Women of childbearing potential and men must agree to use adequate contraception
             (barrier method of birth control) prior to study entry and for the duration of study
             participation. Men should use adequate birth control for at least three months after
             the last administration of sorafenib.

          -  Ability to understand and the willingness to sign a written informed consent. A signed
             informed consent must be obtained prior to any study specific procedures.

        Exclusion Criteria

          -  Cardiac disease: Congestive heart failure > class II New York Heart Association
             (NYHA). Patients must not have unstable angina (anginal symptoms at rest) or new onset
             angina (began within the last 3 months) or myocardial infarction within the past 6
             months.

          -  Prior use of sorafenib

          -  Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI
             of the brain to exclude brain metastasis.

          -  Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.

          -  Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic
             pressure > 90 mmHg, despite optimal medical management.

          -  Known human immunodeficiency virus (HIV) infection.

          -  Active clinically serious infection > CTCAE Grade 2 except for Except Hepatitis B(HBV)
             or Hepatitis C (HCV)

          -  Thrombolic or embolic events such as a cerebrovascular accident including transient
             ischemic attacks within the past 6 months.

          -  Serious non-healing wound, ulcer, or bone fracture.

          -  Evidence or history of bleeding diathesis

          -  Major surgery, open biopsy or significant traumatic injury within 4 weeks of first
             study drug.

          -  Use of St. John's Wort or rifampin (rifampicin).

          -  Known or suspected allergy to sorafenib or any agent given in the course of this
             trial.

          -  Any condition that impairs patient's ability to swallow whole pills.