EFFICACY AND SAFETY OF THE MULTITARGET INHIBITOR AGENT SU11248 IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA - UCSC-OM-SU-01

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005732-27-IT

Enrollment

Registered

2007-07-12

Start date

2007-10-10

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with locally advanced or metastatic hepatocellular carcinoma MedDRA version: 9.1 Level: LLT Classification code 10019695 Term: Hepatic neoplasm

Interventions

Product Name: SU11248 Pharmaceutical Form: Tablet INN or Proposed INN: SUTENT- sunitinib malate Current Sponsor code: SU11248 Concentration unit: mg milligram(s) Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Main Objective: determine the activity of agent SU11248 in terms of response rate, decrease in alpha- fetoprotein serum levels and reduced captation of FDG-glucose at PET-scan;Secondary Objective: - safety profile of SU11248 - time to progression - time to treatment failure - overall survival;Primary end point(s): response rate, assessed with CT-scan according to RECIST criteria, decrease of the alpha-FP serum levels, decrease of FDG captation at PET-scan	—

Measure

Time frame

Main Objective: determine the activity of agent SU11248 in terms of response rate, decrease in alpha- fetoprotein serum levels and reduced captation of FDG-glucose at PET-scan;Secondary Objective: - safety profile of SU11248 - time to progression - time to treatment failure - overall survival;Primary end point(s): response rate, assessed with CT-scan according to RECIST criteria, decrease of the alpha-FP serum levels, decrease of FDG captation at PET-scan

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026