Status:
COMPLETED
Study Evaluating Gefitinib (IRESSA®) in Subjects With Solid Malignancies That Are Locally Advanced, Recurrent or Metastatic
Lead Sponsor:
AstraZeneca
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will determine the safety profile and maximum tolerated dose (MTD) of orally administered gefitinib on a weekly and twice weekly schedule.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00127829
Start Date
July 1 2005
End Date
January 1 2008
Last Update
April 23 2009
Active Locations (2)
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1
Research Site
Los Angeles, California, United States
2
Research Site
Palm Springs, California, United States