BioCentury
ARTICLE | Clinical News

Capesaris: Phase II data

February 25, 2013 8:00 AM UTC

Pooled data from 164 men with androgen deprivation therapy (ADT)-naïve advanced prostate cancer in the open-label, U.S. Phase II G200705 and G200710 trials showed that once-daily oral Capesaris for 28 days led to castration, the primary endpoint defined as a testosterone concentration of <50 ng/dL by day 60, in 49% of patients in the 1,000 mg arm and 56% of patients in the 2,000 mg arm vs. 94% of patients receiving Lupron Depot leuprolide. In castrated patients, Capesaris reduced mean serum total testosterone levels to 23 ng/dL in the 1,000 mg group and to 19 ng/dL in the 2,000 mg group vs. 14 ng/dL for Lupron Depot. Capesaris reduced mean free testosterone levels to 0.9 pg/mL in the 1,000 mg group and to 0.7 pg/mL in the 2,000 mg group vs. 1.7 pg/mL for Lupron Depot. Additionally, Capesaris reduced PSA at day 28 from baseline by 84% in the low-dose group and 73% in the high dose group vs. 56% for Lupron Depot. Capesaris also increased SHBG by 400%. Data were presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium in Orlando. ...