Are there specific criteria used to determine whether patients can receive an investigational drug outside a clinical trial?
To be considered for treatment with an investigational drug outside a clinical trial, generally patients must meet the following criteria: • Have undergone standard treatment that has not been successful. • Be ineligible for any ongoing clinical trials of this drug. • Have no acceptable treatment alternatives. • Have a cancer diagnosis for which the investigational drug has demonstrated activity. • Be likely to experience benefits that outweigh the risks involved. • What should patients do if they are interested in receiving an investigational drug through a special exception or expanded access mechanism? Patients interested in gaining access to investigational drugs should talk to their physician about available options. Physicians can make requests for special exceptions by contacting the study sponsor. Physicians will be required to follow strict guidelines, including gaining approval from their Institutional Review Board and obtaining informed consent from the patient. Informed con
