Status:
COMPLETED
SU011248 in Advanced Hepatocellular Carcinoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Hepatocellular Carcinoma
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 m...
Detailed Description
* Participants will be given a supply of SU011248 capsules to be taken orally every morning for 4 weeks. After taking SU011248 for 4 weeks, there will be a 2 week rest period when the participant will...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00361309
Start Date
April 1 2006
End Date
March 1 2009
Last Update
March 18 2014
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115