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


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Small-Cell Lung Carcinoma, Carcinoma, Non-Small Cell Lung, Lung Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Medical Monitor, MD

Investigator Role:

Study Director

Investigator Affiliation:

Wyeth is now a wholly owned subsidiary of Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3095A1-201

NCT ID:

NCT00067548

Start Date:

Completion Date:

January 2005

Related Keywords:

  • Non-Small-Cell Lung Carcinoma
  • Carcinoma, Non-Small Cell Lung
  • Lung Neoplasms
  • Advanced Non-Small Cell Lung Cancer
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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