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
The purpose of this study is to determine whether TAC-101 as a second line therapy for patients 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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : Placebo
- drug : TAC-101
Phase: Phase 2
Ages Eligible For Study:
- 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.