EUCTR2007-007629-32-BEActive, not recruitingNot Applicable
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
Taiho Pharma USA, Inc.0 sites220 target enrollmentStarted: March 17, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 220
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Male or female patients who meet all of the following criteria are eligible for enrollment in the
- •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 <8;
- •10. Have adequate organ function defined as:
- •a. Platelet count =50 × 109/L;
- •b. Hemoglobin =8.0 g/dL;
- •c. Total bilirubin =3 mg/dL;
- •d. Alanine transaminase (ALT) and aspartate aminotransferase (AST) =5 × ULN;
- •e. Serum creatinine =1.5 × ULN;
- •f. PT-international normalized ratio (INR) =2.3 or PT =6 seconds above control;
- •g. Total white blood cell (WBC) count =2.0 × 109/L;
- •11. Is able to take medications orally (eg, no feeding tube); and
- •12. 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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.
Investigators
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