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

NCT00067548 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2009-08-21

No results posted yet for this study

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

DRUG

EKB-569

Sponsors & Collaborators

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Medical Monitor, MD · Wyeth is now a wholly owned subsidiary of Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2005-01-31
Completion
2005-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00067548 on ClinicalTrials.gov