A Phase II Study of the HSP Inhibitor STA-9090 in Metastatic Ocular Melanoma
- Participants will receive STA-9090 intravenously over 1 hour once a week for the first
three weeks of a 4 week cycle (days 1, 8 and 15).
- During the first cycle (Cycle 1) participants will have the following tests and
procedures performed at the time point indicated: Day 1 and Day 15: clinical exam,
vital signs, ECG and blood tests. Day 2: Biopsy of tumor and blood tests. Day 8:
clinical exam, vital signs and blood tests. Days 16-18: PET scan.
- On Day 1 of all subsequent even cycles (4, 6, 8, etc.) the following tests and
procedures will be performed: clinical exam, vital signs, ECG, blood tests and urine
sample. On days 8 and 15 of all subsequent even cycles the following tests and
procedures will be performed: clinical exam, vital signs and blood tests. On days
22-28 of all even cycles and assessment of the tumor will also be performed.
- On Day 1 of all subsequent odd cycles (3, 5, 7, etc.) the following tests and
procedures will be performed: clinical exam, vital signs and blood tests.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival Rate
To determine the proportion of patients alive, free of disease progression, and still taking STA-9090 at 4 months.
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|