 11. Subjects with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks prior to enrollment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks prior to enrollment, and radiographic stability should be confirmed by comparing a brain scan CT with contrast or MRI with and without contrast performed during the Screening Period to a brain scan performed at least 4 weeks earlier using the same modality. 