Samuel So
Study of TAC-101 as Second Line Treatment in Patients With Advanced Hepatocellular Carcinoma Who Received Sorafenib as First Line Therapy
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
TerminatedStanford Recruiting Status:
TerminatedCondition(s):
Intervention(s):
- Drug: TAC-101
- Drug: Placebo
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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, 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:
o Platelet count great than 50, less than 109/L;
o Hemoglobin 8.0 g/dL;
o Total bilirubin 3 mg/dL;
o Alanine transaminase (ALT) and aspartate aminotransferase (AST) less than or equal to 5 X ULN;
o Serum creatinine 1.5 X ULN;
o PT-international normalized ratio (INR) 2.3 or PT 6 seconds above control
o 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.
Key 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 clinical symptoms of hepatic encephalopathy
- 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 study
- Have had treatment with any of the following within the specified timeframe prior to randomization:
o Any sorafenib within the 14 days prior to randomization
o Major surgery within the 4 weeks prior to randomization
o 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 following:
o 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
o Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
o Previous or concurrent malignancy except for inactive melanoma skin cancer 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
o 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
o Has active or uncontrolled clinically serious infection excluding chronic hepatitis
o 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)
o History or evidence of known central nervous system disease or involvement
o Known allergy or hypersensitivity of TAC 101 and any other components used in the TAC 101 tablet.
Additional Study Details
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 TherapyAnticipated start date:
6/1/2008Lead Sponsor:
Taiho Pharma USA, Inc.Collaborator(s):
- Taiho Pharma USA, Inc.
Investigator(s):
- Samuel So
- Cheryl Cho
- Kerry Hsieh
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
EfficacyPrimary Outcomes:
- Overall survival
Secondary Outcomes:
- Radiologic progression-free survival
- Time To Progression
- Adverse event profile and tolerability TAC-101 as second line therapy
- Effects on plasma levels of the tumor marker alpha-fetoprotein (AFP) and AFP-L3
- The relationship between the PK of TAC-101 and its metabolites (blood sampling for PK is optional),and safety and efficacy parameters, including hepatic function
- The effects on selected RAR-related factors and a selected growth factor
- To investigate antitumor activity after treatment discontinuation
- To investigate the relationship between tumor gene expression (mRNA expression) of co-activators, co-repressors and efficacy parameters
Total Number to be Enrolled:
220Total Number to be Enrolled at Stanford:
10More Information
Secondary ID(s):
- HEP0015
- NCT00687596
- TAC101-202
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
9/29/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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