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A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma, Liver Cancer

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Trial Information

A Phase II Study of SU011248 in Advanced Hepatocellular Carcinoma

- 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

- 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.

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

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Andrew X. Zhu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

April 2006

Completion Date:

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Cancer
  • liver cancer
  • HCC
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617