A Phase 1 Protocol of 5-Azacytidine and Erlotinib in Advanced Solid Tumor Malignancies

Primary Objectives To evaluate the safety and activity of administering a combination of two
antineoplastic agents, erlotinib and 5-azacytidine, in an effort to inhibit multiple
operative growth factor pathways directly and via epigenetic mechanisms, as therapy for the
treatment of advanced or metastatic cancer, as determined by the quality and quantity of
adverse events.

Secondary Objectives To evaluate the response to treatment as determined by the achievement
of an objective tumor response, progression-free survival and overall survival.