Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic

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

This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.

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