SU011248 in Advanced Hepatocellular Carcinoma

Completed · Phase 2

Conditions studied: Hepatocellular Carcinoma, Liver Cancer

In brief

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.

Key facts

Study ID: NCT00361309
Run by: Massachusetts General Hospital
People needed: 34
Starts: 2006-04-01
Expected to finish: 2009-03-01
Last updated by the study team: 2014-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Massachusetts General Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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