A Phase I, Open-Label, Dose Escalation Study Evaluating High-Dose Gefitinib (IRESSA®) on Weekly and Twice Weekly Schedules in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic

Inclusion Criteria:

- Histologically confirmed solid tumor refractory to conventional treatment or whom no
standard of treatment exists

- Life expectancy of > 12 weeks

- World Health Organization (WHO) performance status of < 2

Exclusion Criteria:

- Known severe hypersensitivity to gefitinib or any of the excipients of this product

- Less than 4 weeks since completion of prior chemotherapy or radiation therapy (except
nitrosoureas or mitomycin-C which must have a wash out period of 6 weeks)

- Incomplete healing from previous oncologic or other major surgery