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

Completed · Phase 1

Conditions studied: Tumors

In brief

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

Key facts

Study ID

NCT00127829

Run by

AstraZeneca

People needed

66

Starts

2005-07-01

Expected to finish

2008-01-01

Last updated by the study team

2009-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — Palm Springs, California, United States

Full record on ClinicalTrials.gov

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