Study of TAC-101 as Second Line Treatment in Patients With Advanced Hepatocellular Carcinoma Who Received Sorafenib as First Line Therapy

Not Recruiting

Trial ID: NCT00687596


The purpose of this study is to determine whether TAC-101 as a second line therapy for participants who received Sorafenib as first line therapy is effective in slowing tumor activity in patients with advanced hepatocellular carcinoma. The study is also looking at the safety of TAC-101 following treatment with Sorafenib.

Official Title

A Phase 2, Double-blind, Placebo-controlled, Randomized, International, Multicenter Study of Oral TAC 101 as Second Line Treatment in Patients With Advanced Hepatocellular Carcinoma Who Received Sorafenib as First Line Therapy

Stanford Investigator(s)

Samuel So, MD
Samuel So, MD

Lui Hac Minh Professor in the School of Medicine


Inclusion Criteria:

   - Provide written informed consent prior to performance of any study procedures.

   - Is at least 18 years of age.

   - Have a diagnosis of advanced unresectable histologically confirmed HCC (excluding
   fibrolamellar carcinoma).

   - Have discontinued from first line treatment with sorafenib monotherapy for any reason
   (ie, tumor disease progression, intolerance) at least 14 days prior to planned
   randomization but have not received any second line treatment for HCC.

   - Have recovered from any significant sorafenib-related treatment toxicities prior to
   randomization (Grade 1).

   - Have at least 1 target lesion that is viable (has vascularization) and can be
   accurately measured according to RECIST.

   - Patients who have received local therapy prior to sorafenib administration (radiation,
   surgery, hepatic arterial embolization, chemoembolization, RFA, percutaneous ethanol
   injection [PEI] or cryoablation) are eligible. Local therapy must be completed at
   least 4 weeks prior to the baseline scan.

   - Have ECOG score of 0, 1, or 2.

   - Child-Pugh score <8.

   - Have adequate organ function defined as:

      - Platelet count great than 50, less than 109/L;

      - Hemoglobin 8.0 g/dL;

      - Total bilirubin 3 mg/dL;

      - Alanine transaminase (ALT) and aspartate aminotransferase (AST) less than or
      equal to 5 X ULN;

      - Serum creatinine 1.5 X ULN;

      - PT-international normalized ratio (INR) 2.3 or PT 6 seconds above control

      - Total white blood cell (WBC) count 2.0 109/L

   - Is able to take medications orally (eg, no feeding tube).

   - Women of childbearing potential must have a negative pregnancy test (urine or serum)
   prior to randomization and within 2 days prior to starting the study drug. Females
   must agree to adequate non-estrogenic birth control if conception is possible during
   the study; and males must agree to adequate birth control during the study and up to 6
   months after the discontinuation of study medication.

Exclusion Criteria:

   - History of DVT, PE, myocardial infarction (MI), CVA, transitory ischemic attack (TIA),
   or any other significant TE during the last 3 years.

   - Have clinically significant symptoms of hepatic encephalopathy or known brain

   - Patients who have had clinically significant acute gastrointestinal bleeding as a
   result of portal vein hypertension within 4 weeks prior to randomization are excluded;
   however, patients with a history of acute gastrointestinal bleeding that have received
   appropriate treatment, ie, ligation of varices, are eligible.

   - Are receiving therapeutic regimens of anticoagulants, with the exception of
   prophylaxis care of indwelling venous access devices.

   - Have received a liver transplant.

   - Are taking prohibited medication.

   - Have received a previous systemic therapy (including investigational agents) other
   than sorafenib (see Inclusion Criterion 4) for treatment of HCC. Patients
   participating in surveys or observational studies are eligible to participate in this

   - Have had treatment with any of the following within the specified timeframe prior to

      - Any sorafenib within the 14 days prior to randomization.

      - Major surgery within the 4 weeks prior to randomization.

      - Any transfusion, treatment with blood component preparation, received.
      erythropoietin , albumin preparation, and granulocyte colony-stimulating factor
      (G CSF) within the 2 weeks prior to randomization.

   - Has a serious illness or medical condition(s) including, but not limited to the

      - Known gastrointestinal disorder, including malabsorption, chronic nausea,
      vomiting, or diarrhea present to the extent that it might interfere with oral
      intake and absorption of the study medication.

      - Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome
      (AIDS)-related illness.

      - Previous or concurrent malignancy except for basal cell carcinoma and/or in situ
      carcinoma of the cervix, or other solid tumor treated curatively and without
      evidence of recurrence for at least 3 years prior to the study.

      - Uncontrolled metabolic disorders or other nonmalignant organ or systemic diseases
      or secondary effects of cancer that induce a high medical risk and/or make
      assessment of survival uncertain.

      - Has active or uncontrolled clinically serious infection excluding chronic

      - Other severe acute or chronic medical or psychiatric condition or laboratory
      abnormality that may increase the risk associated with study participation or
      study drug administration, or may interfere with the interpretation of study
      results, and in the judgment of the Investigator would make the patient
      inappropriate for entry into this study (eg, active urinary tract infection).

      - Known allergy or hypersensitivity of TAC 101 and any other components used in the
      TAC 101 tablet.


drug: TAC-101

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Kerry Hsieh

New Trial Alerts