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SU011248 in Advanced Hepatocellular Carcinoma

A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00361309
Enrollment
34
Registered
2006-08-08
Start date
2006-04-30
Completion date
2009-03-31
Last updated
2014-03-18

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

Conditions

Hepatocellular Carcinoma, Liver Cancer

Keywords

liver cancer, HCC

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 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further.

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 not take any capsules. This 6-week period is referred to as 1 cycle. * Participants will continue to receive SU011248 study treatment as long as their disease does not worsen significantly and they are not experiencing any serious side effects. * During cycle 1 of study treatment, the participant will come to the outpatient clinic once a week for blood work, physical examination and dynamic contrast enhanced magnetic resonance imaging (DCE-MRI), which is done two weeks after they start taking study treatment. * During cycle two and every cycle thereafter, the participant will be asked to come to the outpatient clinic once every two weeks for physical examination, blood work and urine tests. * A CT scan or MRI scan to assess the tumor will be performed once during each cycle for the first three cycles, then once every 2 cycles thereafter. ACTH stimulation test will be done every 2 cycles. A MUGA scan may be done at anytime at the discretion of the the study doctor.

Interventions

Patients will receive SU011248 37.5 mg/day for 4 weeks continuously followed by 2 weeks of rest per cycle (each cycle = 6 weeks).

Sponsors

Beth Israel Deaconess Medical Center
CollaboratorOTHER
Brigham and Women's Hospital
CollaboratorOTHER
Dana-Farber Cancer Institute
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.2 years

Secondary

MeasureTime frame
Number of adverse events in patients treated with SU011248 for advanced hepatocellular carcinoma2 years
Objective Response Rate2 years
Overall Survival2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026