NCT00067548

Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer

A Phase 2 Study of EKB-569 in Subjects With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This non-randomized, open-label, outpatient clinical trial is designed to assess the safety and efficacy of daily orally administered EKB-569 in subjects with advanced non-small cell lung cancer. Patients must have been previously treated with a platinum- and docetaxel-based therapy either given concurrently or as separate regimens. The primary objective of the study is to assess the clinical activity of EKB-569 administered orally as a second-line or later stage treatment in subjects with advanced non-small cell lung cancer. Secondary objectives include: * To further evaluate the safety of EKB-569 * To explore additional clinical activity parameters * To explore subject survival * To evaluate the pharmacokinetics of EKB-569 * To assess subject reported outcomes EKB-569 will be administered orally as a single-agent. Eligible subjects will take EKB-569 daily as long as they do not have progressive disease and are tolerating treatment.

Conditions

• Non-Small-Cell Lung Carcinoma
• Carcinoma, Non-Small Cell Lung
• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	EKB-569

Timeline

• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2003-08-25
• Last updated: 2009-08-21