Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer
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.
|Non-Small-Cell Lung Carcinoma Carcinoma, Non-Small Cell Lung Lung Neoplasms||Drug: EKB-569||Phase 2|
|Study Design:||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of EKB-569 in Subjects With Advanced Non-Small Cell Lung Cancer|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00067548
|Study Director:||Medical Monitor, MD||Wyeth is now a wholly owned subsidiary of Pfizer|