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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00067548
Study type	Interventional
Source	Wyeth is now a wholly owned subsidiary of Pfizer
Contact
Status	Completed
Phase	Phase 2
Completion date	January 2005

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