AN OPEN LABEL INTERNATIONAL MULTI-CENTER PHASE 2 ACTIVITY AND SAFETY STUDY OF SU011248 IN PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA

• Conditions: Histologically confirmed diagnosis of hepatocellular carcinoma. Patients with the fibrolamellar histology or a mixed histology are not eligible.; MedDRA version: 8.0Level: VTcClassification code 10019697

• Registration Number: EUCTR2005-000525-30-GR
• Lead Sponsor: Pfizer Hellas A.E.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

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 < 1.5 x ULN.
10. Life-expectancy of = 3 months.
11. Signed and dated an informed consent indicating that the patient (or legally
acceptable representative) has been informed of all the pertinent aspects of
the trial prior to enrollment.
12. Willingness and ability to comply with scheduled visits, treatment plans,
laboratory tests, and other study procedures.

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

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 <4 weeks of starting study treatment.
7. 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 with no evidence of recurrent disease for 12
months.
8. History of or known brain metastases, spinal cord compression, or carcinomatous
meningitis, or new evidence of brain or leptomeningeal disease.
9. 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.
10. 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.
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified