At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed hepatocellular carcinoma
- ✓Unresectable disease (not amenable to curative surgery or liver transplant)
- ✓Measurable disease by radiographic imaging
- ✓Adequate organ function
- ✕Any prior systemic treatment for hepatocellular carcinoma
- ✕Clinically relevant ascites
- ✕Severe hemorrhage within 4 weeks before study start
- ✕Second malignancy diagnosed within 3 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label International Multi-Center Phase 2 Activity And Safety Study Of SU011248 In Patients With Unresectable Hepatocellular Carcinoma
In Brief
A Phase 2 clinical trial evaluating Sunitinib (SU011248) for Liver Neoplasms and Unresectable Hepatocellular Carcinoma. Completed, enrolled 37 participants across 8 sites in 3 countries.
Detailed Summary
The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg \[milligrams\] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival
Study Details
Timeline
Interventions
Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.