Histologically confirmed diagnosis of hepatocellular carcinoma. Patients with the fibrolamellar histology or a mixed histology are not eligible. MedDRA version: 8.0 Level: VTc Classification code 10019697
Conditions
Sponsors
Pfizer Hellas A.E.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of hepatocellular carcinoma. Patients with the fibrolamellar histology or a mixed histology are not eligible. 2. Patients must present with disease not amenable to curative surgery (i.e. either hepatectomy, or liver transplant). 3. Patients previously undergoing local treatment, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneaous ethanol injection, or cryoablation are eligible if they have subsequently progressed or recurred. A minimum delay of 4 weeks is required between local therapy and progression. 4. 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 less than/ equal to 1. 5. Measurable disease according to RECIST. 6. No cirrhosis or cirrhotic status up to Child-Pugh class B. 7. 18 years of age or older. 8. ECOG performance status 0 or 1. 9. Required baseline laboratory data within the following parameters: - Neutrophils =1,500/mL - Platelets =60,000/mL - Hemoglobin =8.5 g/dL - Serum albumin=2.8 g/dL - Serum bilirubin less than/equal to 3 mg/dL - Serum aspartate aminotransferase (AST; serum glutamate-oxalate transferase [SGOT]) and serum alanine aminotransferase (ALT; serum glutamate-pyruvate transferase [SGPT]) less than /equal to 5 x ULN - INR less thna /equal to 1.7 or Prothrombin time (PT) less than/equal to 6 sec over ULN - Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with any systemic treatment for HCC. 2. Prior treatment on a SU011248 clinical trial. 3. Prior local therapy (such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation) of target lesions at any prior time, unless progressed or recurred as per RECIST or WHO. 4. Prior history of liver transplant. 5. Presence of clinically relevant ascites (i.e. requiring paracentesis). 6. NCI CTCAE Grade 3 hemorrhage 450 msec for males or > 470 msec for females. 11. Hypertension that cannot be controlled by medications (blood pressure >150/90 mmHg despite optimal medical therapy). 12. Treatment with anticonvulsant agents and treatment with therapeutic doses of warfarin currently or within 2 weeks prior to first day of SU011248 administration. Low dose warfarin for DVT prophylaxis is permitted (up to 2 mg/day). Low molecular weight heparin is allowed. 13. Inability to swallow oral medications, or presence of active inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea. 14. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 15. Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment. 16. 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. 17. Receipt of any investigational agent prior to study entry. 18. Current treatment on another therapeutic clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the antitumor activity of single-agent SU011248 at a dose of 50 mg orally once daily for 4 consecutive weeks repeated every 6 weeks in patients with unresectable hepatocellular carcinoma.;Secondary Objective: - To assess measures of clinical benefit and duration of tumor control - To evaluate the safety and tolerability of SU011248 - To evaluate SU011248 and SU012662 trough concentrations (Ctrough) and to correlate these plasma concentrations with activity and safety parameters - To explore the correlations of cancer biomarkers with cancer- and treatment- related outcomes. ;Primary end point(s): Objective response rate (ORR) as determined according to RECIST | — |
Countries
Greece
Outcome results
None listed