Advanced Hepatocellular carcinoma (HCC) MedDRA version: 9.1 Level: LLT Classification code 10019828 Term: Hepatocellular carcinoma non-resectable
Conditions
Interventions
Product Name: TAC-101
Pharmaceutical Form: Film-coated tablet
CAS Number: 125973-56-0
Current Sponsor code: TAC-101
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Taiho Pharma USA, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients who meet all of the following criteria are eligible for enrollment in the study: 1. Provide written informed consent prior to performance of any study procedures; 2. Is at least 18 years of age; 3. Have a diagnosis of advanced unresectable histologically confirmed HCC (excluding fibrolamellar carcinoma); 4. 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; 5. Have recovered from any significant sorafenib-related treatment toxicities prior to randomization (=Grade 1); 6. Have at least 1 target lesion that is viable (has vascularization) and can be accurately measured according to RECIST; 7. 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; 8. Have ECOG score of 0, 1, or 2; 9. Child-Pugh score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients should be excluded from this study if they do not fulfill the inclusion criteria, or if any of the following conditions are observed: 1. History of DVT, PE, myocardial infarction (MI), CVA, transitory ischemic attack (TIA), or any other significant TE during the last 3 years; 2. Have clinically significant symptoms of hepatic encephalopathy or known brain metastasis; 3. 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; 4. Are receiving therapeutic regimens of anticoagulants, with the exception of prophylaxis care of indwelling venous access devices; 5. Have received a liver transplant; 6. Are taking prohibited medication as described in Section 7.3; 7. 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 study; 8. Have had treatment with any of the following within the specified timeframe prior to randomization: a. Any sorafenib within the 14 days prior to randomization; b. Major surgery within the 4 weeks prior to randomization; c. 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; 9. Has a serious illness or medical condition(s) including, but not limited to the following: a. 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; b. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness; c. 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; d. 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; e. Has active or uncontrolled clinically serious infection excluding chronic hepatitis; f. 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); or g. Known allergy or hypersensitivity of TAC-101 and any other components used in the TAC-101 tablet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate Overall Survival ;Secondary Objective: To investigate antitumor activity (progression-free survival [PFS] Time to Tumor Progression [TTP]) > To assess the adverse event profile and tolerability of TAC 101 as second line treatment;Primary end point(s): The primary efficacy endpoint is Overall Survival. Survival is defined as the time from date of randomization to date of death. In the absence of death confirmation or for patients alive at the time of analysis, survival time will be censored at the date of the last study follow-up. | — |
Countries
Belgium, France, Germany, Greece, Italy, United Kingdom
Outcome results
None listed