According to a press release from Merck & Co., an investigational agent called odanacatib (MK-0822) may be able slow the rates of breakdown and rebuilding of bone (”bone turnover”) in patients with metastatic prostate and breast cancers. Phase III clinical trials are planned in both disease states.
Data from a randomized Phase II clinical trial comparing odanacitib to zoledronic acid in women with metastatic breast cancer that had spread to the bones are to be presented at the 2008 American Society of Clinical Oncology (ASCO) annual meeting.
Treatment with oral odanacatib 5 mg once daily (n = 29) reduced the level of urinary N-telopeptide (uNTx), a commonly used marker of bone resorption (breakdown), by 77 percent from baseline levels over 4 weeks. These results were seen as early as Day 7, the first measurement point. Treatment with intravenous zoledronic acid 4 mg (n = 14) reduced uNTx by 73 percent. Decreases in other markers of bone turnover were also observed.
Common adverse events to odanacitib included nausea, vomiting, headache and bone pain. Two patients in the odanacatib group experienced mild skin adverse events (rash and pruritis), both of which resolved within one week without discontinuation of study medication. A decreased lymphocyte count was the most common laboratory adverse event in both treatment groups.
Filed under: Drugs in development, Management, Treatment
