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ZOLINZA (vorinostat) in combination with bortezomib demonstrated clinical activity
Date:12/8/2007

or 400 mg daily for 14 days in combination with bortezomib 0.7 or 0.9 mg/m2 I.V. on days 4, 8, 11 and 15 or in combination with bortezomib 0.9, 1.1, or 1.3 mg/m2 I.V. on days 1, 4, 8 and 11. Cycles were repeated every 21 days for a maximum of 8 cycles until progressive disease or intolerable toxicity. The primary objective was to determine MTD; secondary objectives included assessment of activity (using EBMT criteria) and safety and tolerability of the combination regimen. The median age of patients in the study was 61 years (45-76) and the median number of prior anti-cancer therapies was 3 (range of 1-14), with 25 percent (n=6) of patients previously treated with bortezomib.

Although the MTD has not yet been determined, of the 21 evaluable patients who received the combination regimen, as assessed using EBMT criteria, 48 percent had a partial (n=5) or minimal (n=5) response. Among the six patients previously treated with bortezomib, two achieved a partial response and three had a minimal response. Two patients experienced dose-limiting toxicities (transient AST elevation and thrombocytopenia). The most common drug-related adverse events among all patients were nausea (n=14), thrombocytopenia (n=13), diarrhea (n=12), vomiting (n=12), fatigue (n=10) anemia (n=6) and neutropenia (n=6). Accrual continues to determine the MTD.

In the second Phase I study lead by Dr. Ashraf Badros, University of Maryland, and sponsored by the Division of Cancer Treatment and Diagnosis, National Cancer Institute, 23 patients with relapsed or refractory multiple myeloma were administered oral ZOLINZA (100 mg bid, 200 mg bid, 400 mg daily or 500 mg daily) on days 4-11 over a 21-day period in combination with bortezomib (1.0 or 1.3 mg/m2 I.V. on days 1, 4, 8 and 11). Cycles were repeated every 21 days for a maximum of 8 cycles. If no response was observed at Cycle 2, dexamethasone 20 mg was added on days 4-8. The primary objective was to determine the MTD and pharmac
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Contact: Gina Juliano
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Cohn & Wolfe
Source:Eurekalert

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