A Phase II Study of Suberoylanilide Hydroxamic Acid and Bortezomib in Advanced Soft Tissue Sarcomas
I. To determine the objective response rate in patients with advanced soft tissue sarcoma
treated with vorinostat and bortezomib.
I. Characterize the toxicity of this regimen in these patients. II. Evaluate the
progression-free survival and median overall survival of patients treated with this regimen.
Patients receive vorinostat orally (PO) once daily on days 1-14. Patients also receive
bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every
21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 6 months for up to 2
years. (As of Addendum 7, patient follow-up no longer required.)
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Confirmed response rate defined as completer response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST)
Up to 2 years
United States: Food and Drug Administration
|Johns Hopkins University||Baltimore, Maryland 21205|
|Mayo Clinic||Rochester, Minnesota 55905|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|
|Mayo Clinic in Florida||Jacksonville, Florida 32224|
|Metro-Minnesota CCOP||St. Louis Park, Minnesota|