 - Women of childbearing potential are required to have a negative serum pregnancy test with a sensitivity of at least 25 mIUmL within 7 days prior to the first dose of GDC-0449 serum or urine; a pregnancy test serum or urine will be administered every 4 weeks if their menstrual cycles are regular or every 2 weeks if their cycles are irregular while on study within the 24-hour period prior to the administration of GDC-0449; a positive urine test must be confirmed by a serum pregnancy test; prior to dispensing GDC-0449, the investigator must confirm and document the patients use of two contraceptive methods, dates of negative pregnancy test, and confirm the patients understanding of GDC-0449 cause serious or life-threatening birth defects; patients must continue highly effective contraception during therapy and for 24 months after the last dose of GDC-0449 