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A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms

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Trial Information

A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Histologically or cytologically documented diagnosis of progressive or recurrent,
locally advanced or metastatic NSCLC; a tumor that expresses at least one member of
the erbB family of receptors; failed or relapsed after receiving a
platinum-containing regimen as therapy; at least one measurable target lesion as
defined by RECIST that has not been irradiated.

Exclusion Criteria:

- Prior exposure to agents that target the erbB receptor family; unknown response to
prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks
prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more
than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2
weeks prior to baseline disease assessment; prior irradiation to areas encompassing
greater than 30% of marrow-bearing bone; brain metastases.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4161003

NCT ID:

NCT00050830

Start Date:

January 2003

Completion Date:

November 2005

Related Keywords:

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

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteBlendora, California  91740
Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteDetroit, Michigan  48201
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteMilwaukee, Wisconsin  53215
Pfizer Investigational SiteBristol, Tennessee  37620
Pfizer Investigational SiteSalt Lake City, Utah  84112