The trial is expected to enroll 49 patients with metastatic breast cancer who have relapsed following prior treatment with an anthracycline and taxane regimen.
The primary objective of the study is overall response rate (including patients with complete responses and partial responses). Secondary objectives of the study include, time to progression, duration of response and overall survival, as well as determination of toxicity and pharmacokinetic characteristics for Symadex.
Symadex (formerly C-1311) is a next-generation investigational anticancer drug that has shown a potentially novel, targeted mechanism of action in preclinical studies.
“Even though significant advances have been made in the treatment of early breast cancer, treatment options for advanced breast cancer are still limited and metastatic breast cancer is almost always fatal,” stated Dr Robert Capizzi, chief medical officer at Xanthus.
Dr Capizzi went on to say that the company is enthusiastic about the potential of Symadex in metastatic breast cancer because prior studies suggest that the drug’s activity “will not be affected by acquired resistance to the commonly-used first-line therapies.”