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
- 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the progression free survival of hepatocellular carcinoma (HCC) patients treated with SU011248.
Andrew X. Zhu, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|