A Phase I Study of STA-9090 in Patients With Advanced Hepatocellular Carcinoma
Study treatment is given in 4-week time periods called cycles. Patients will receive
ST-9090 for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090
will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or
tube) placed in the vein. Each infusion will last about 60 minutes.
During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to
thirty days after the last dose, patients will return for a physical exam, blood tests,
urine test, EKG, and CT or MRI of chest and abdomen.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the Phase 2 dose of STA 9090 given once weekly in patients with advanced hepatocellular carcinoma
Dose escalation/de-escalation study will be performed in order to determine the Phase 2 dose of STA-9090 given once weekly in patients with advanced hepatocellular carcinoma. The dose limiting toxicities will be determined at each dose level.
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|