Ortho Biotech Oncology has unblinded a Phase III study of its investigational drug abiraterone acetate plus prednisone for patients with metastatic advanced prostate cancer because early results indicate that the combination is both safe and effective.
The study, COU-AA-301, involved almost 1,200 patients with castration resistant prostate cancer who had been randomized to receive either abiraterone acetate plus prednisone, or a placebo plus prednisone.
However, an independent monitoring committee has recommended that it be unblinded and that those patients in the placebo arm be offered the abiraterone acetate plus prednisone. This recommendation comes after a data analysis convinced the committee that not only has the therapy shown a statistically significant improvement in overall survival but it has also demonstrated an acceptable safety profile.
A program to grant early access to the treatment to qualified patients in the US could be underway as soon as October.
CANCER TYPE(S)
Advanced metastatic prostate cancer
TREATMENT TYPE(S)
Anti-androgenic agent
The National Cancer Institute defines abiraterone acetate as " An orally active acetate salt of the steroidal compound abiraterone with antiandrogen activity. Abiraterone inhibits the enzymatic activity of steroid 17alpha-monooxygenase (17alpha-hydrolase/C17,20 lyase complex), a member of the cytochrome p450 family that catalyzes the 17alpha-hydroxylation of steroid intermediates involved in testosterone synthesis. Administration of this agent may suppress testosterone production by both the testes and the adrenals to castrate-range levels."
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