A Phase II Study of SU011248 in Patients With Metastatic Mucosal or Acral/Lentiginous Melanoma
- Participants will be given a bottle of SU011248 pills and will be asked to take pills
once daily for 28 days on an ongoing basis. Participants will return every 28 days for
- During all treatment cycles, participants will have a physical exam and undergo blood
tests at every visit.
- After a month of receiving the study drug participants will undergo a repeat PET scan
to see if the drug has caused any early changes to their cancer.
- At week 8 a repeat chest, abdomen and pelvic CT will be performed.
- Participants will be on this research study for approximately one year.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate of this patient population to treatment with SU011248
F. Stephen Hodi, MD
Dana-Farber Cancer Institute
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|
|Vanderbilt University||Nashville, Tennessee 37232-6305|
|Washington University in St. Louis||St. Louis, Missouri 63110|