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

Phase 2

Completed

• Conditions: Non-Small-Cell Lung Carcinoma; Carcinoma, Non-Small Cell Lung; Lung Neoplasms

• Registration Number: NCT00067548
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-08-21
• Study First Submitted QC: 2003-08-22
• Study First Posted: 2003-08-25
• Primary Completion: 2005-01
• Study Completion: 2005-01
• Status Verified: 2009-08
• Last Update Submitted: 2009-08-20
• Last Update Posted: 2009-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Signed and dated, institutional review board (IRB) or independent ethics committee (IEC)-approved informed consent form before any protocol-specific screening procedures
• Histologic and/or cytologic diagnosis of locally-advanced or metastatic non-small cell lung cancer in subjects who are not curable by conventional therapy

Exclusion Criteria

• Chemotherapy, radiotherapy, anticancer immunotherapy, or investigational agents within 4 weeks of treatment day 1 (6 weeks if the previous regimen included mitomycin or nitrosoureas)
• Prior radiotherapy to >25% of bone marrow
• Prior epidermal growth factor receptor-targeting therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified