Advanced Hepatocellular Carcinoma MedDRA version: 9.1 Level: LLT Classification code 10049010 Term: Carcinoma hepatocellular
Conditions
Interventions
Trade Name: Sutent
Product Name: Sutent
Pharmaceutical Form: Capsule, hard
CAS Number: 341031-54-7
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 12.5 mg-50 mg
Tr
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically-confirmed diagnosis of hepatocellular carcinoma that is locally advanced or metastatic (histological diagnosis obtained from a prior tumor biopsy specimen is acceptable). 2. Measurable disease according to RECIST. At least one target lesion should not have previously received any local therapy, such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radio-frequency ablation, percutaneous ethanol injection or cryoablation, unless it has subsequently progressed according to RECIST. 3. Resolution of all acute toxic effects of any prior local treatment to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade =1. 4. Child-Pugh class A (for the determination of the Child-Pugh class, use the table reported in Appendix 5). 5. Eighteen years of age or older. 6. ECOG performance status 0 or 1. 7. Required baseline laboratory data within the following parameters: • Neutrophils = 1,500/µL • Platelets = 75,000/µL • Hemoglobin = 9.0 g/dL • Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) = 5 x ULN • Serum creatinine = 1.5 x ULN • INR 3.5 g/dL (* = 2.8 g/dL) • Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior systemic treatment for HCC, including prior treatment with sunitinib, or sorafenib, or another investigational agent. 2. Any prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, TACE, hepatic arterial infusion, radiofrequency ablation, percutaneous ethanol injection or cryoablation) within 4 weeks of study entry. 3. Prior history of liver transplant. 4. Presence of clinically relevant ascites (e.g., requiring therapeutic paracentesis or that can be classified as Child-Pugh score = 2). 5. NCI CTCAE grade = 3 hemorrhage within 4 weeks of starting study treatment, or documented variceal hemorrhage of any grade within 12 months of study entry (as documented by endoscopy). 6. Presence of esophageal varices at risk of bleeding and/or serious or non-healing wound/ulcer (as documented by endoscopy). 7. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study entry. 8. Any of the following within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism. 9. Diagnosis of any second malignancy within the last 3 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated without evidence of recurrent disease for 12 months. 10. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. 11. Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females. 12. Hypertension that cannot be controlled by medications (blood pressure >150/100 mm Hg despite optimal medical therapy). 13. Treatment with potent CYP3A4 inhibitor within 7 days of study entry or with potent CYP3A4 inducer within 12 days of study entry. 14. Concomitant treatment with botanical formulation having an approved indication for cancer treatment, such as “Xiao Chai Hu Tang”, “Kanglaite”, etc. 15. Ongoing treatment with therapeutic levels of coumarin derivatives or oral anti-vitamin K agents. 16. Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea. 17. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 18. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to study enrollment. 19. Fertile patients unwilling or unable to use adequate contraception, as defined in Life Style Guidelines, Section 4.4, to prevent pregnancy during the study. 20. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that OS on sunitinib is superior or equivalent to OS on sorafenib in patients with advanced hepatocellular carcinoma;Secondary Objective: • To compare PFS and TTP between both treatment arms • To evaluate the safety and tolerability of sunitinib in this patient population • To compare patients’ health status between both treatment arms.;Primary end point(s): Overall Survival (OS) | — |
Countries
Belgium, Czech Republic, France, Germany, Hungary, Italy, Portugal, Spain, Sweden, United Kingdom
Outcome results
None listed