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
- Conditions
- Advanced Hepatocellular carcinoma (HCC)MedDRA version: 9.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectable
- Registration Number
- EUCTR2007-007629-32-DE
- Lead Sponsor
- Taiho Pharma USA, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 220
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 <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
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 t
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method