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

Phase 1

Completed

• Conditions: Tumors
• Interventions: Drug: Gefitinib

• Registration Number: NCT00127829
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-08-05
• Study First Submitted QC: 2005-08-05
• Study First Posted: 2005-08-09
• Study Completion: 2008-01
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-22
• Last Update Posted: 2009-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Gefitinib	Gefitinib (IRESSA®)

Trial Locations

Locations (1)

Research Site; 🇺🇸 Palm Springs, California, United States