Clinical trial · Interventional
SU011248 in Advanced Hepatocellular Carcinoma
A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma
NCT00361309CI-TRIAL-00014052completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to begin to collect information and try to learn whether SU011248 works in treating patients with advanced liver cancer. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SU011248 | Drug | Sunitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SU011248
- description
- Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks). Patients will be continued on treatment until disease progression, limiting toxicity, or patient withdrawal of consent.
- interventionNames
- Drug: SU011248
Primary outcomes (1)
- measure
- Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Number of adverse events in patients treated with SU011248 for advanced hepatocellular carcinoma
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed HCC and should have metastatic or locally advanced unresectable disease * Measurable disease * 0-1 prior systemic chemotherapy regimens for HCC * Age 18 years or older * Life expectancy of greater than 12 weeks * ECOG performance status of 0-1 * Adequate organ and marrow function * Women of child-bearing potential must have a negative pregnancy test prior to study entry Exclusion Criteria: * Chemotherapy, radiotherapy or major surgery within 4 weeks of study entry * Receiving any other investigational agents within past 30 days * Known brain metastases * CLIP score \> 3 * Chronic diarrhea or any disorder that will limit adequate absorption of SU011248 * Prolongation of QTc \> 450 msec in screening electrocardiogram or history of familial long QT syndrome * Uncontrolled intercurrent illness * Pregnant or lactating women * Greater than or equal to 2g of protein/24hr
References
Publications (1)
- DERIVEDSahani DV, Jiang T, Hayano K, Duda DG, Catalano OA, Ancukiewicz M, Jain RK, Zhu AX. Magnetic resonance imaging biomarkers in hepatocellular carcinoma: association with response and circulating biomarkers after sunitinib therapy. J Hematol Oncol. 2013 Jul 10;6:51. doi: 10.1186/1756-8722-6-51. PMID 23842041