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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00067548
Recruitment Status : Completed
First Posted : August 25, 2003
Last Update Posted : August 21, 2009
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Carcinoma, Non-Small Cell Lung Lung Neoplasms Drug: EKB-569 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of EKB-569 in Subjects With Advanced Non-Small Cell Lung Cancer
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00067548


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
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ClinicalTrials.gov Identifier: NCT00067548    
Other Study ID Numbers: 3095A1-201
First Posted: August 25, 2003    Key Record Dates
Last Update Posted: August 21, 2009
Last Verified: August 2009
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Advanced Non-Small Cell Lung Cancer
Additional relevant MeSH terms:
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Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
EKB 569
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action