EFFICACY AND SAFETY OF THE MULTITARGET INHIBITOR AGENT SU11248 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA - UCSC-OM-SU-01
- Conditions
- patients with locally advanced or metastatic hepatocellular carcinomaMedDRA version: 9.1Level: LLTClassification code 10019695Term: Hepatic neoplasm
- Registration Number
- EUCTR2005-005732-27-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
- advanced( localized disease but surgically unresectable or metastatic) histologically/cytologically proven hepatocellular carcinoma (with alfa-FP > 400 ng/ml)
- no prior chemiotherapy, immunotherapy or previous local treatment (RF, PEI, CE)
- adeguate bone marrow, liver, renal functions
- life expectancy > 12 week
- adults >18 years of age
- negative pregnancy test
- signed informed consent
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
- prior treatment with any chemotherapy agent, VEGF/VEGF-R inhibitors, or antiangiogenesis treatment
- patients who are candidates for a radical surgical treatment
- need for CYP3A4 inhibitors or CYP3A4 or CYP1A2 inducers
- requirement of anticoagulant therapy
- uncontrolled brain metastases
- women having procreative potential who are not taking careful precautions to prevent pregnancy, or breast-feeding
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