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

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Gefitinib

Criteria

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