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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small-Cell Lung Carcinoma, Non-Small Cell Lung Carcinoma, Lung Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00067548
Pfizer
Completed
Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer

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Study Evaluating EKB-569 in Advanced Non-Small Cell Lung Cancer
A Phase 2 Study of EKB-569 in Subjects With 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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • Non-Small-Cell Lung Carcinoma
  • Carcinoma, Non-Small Cell Lung
  • Lung Neoplasms
Drug: EKB-569
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
January 2005
January 2005   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00067548
3095A1-201
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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