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

Purpose

The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.

Condition	Intervention	Phase
Lung Neoplasms	Drug: CI 1033	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Secondary objectives also include determining the safety of CI 1033 and the detection of any correlations between baseline tumor erbB expression and efficacy. Safety will be assessed by spontaneous AE reporting, physical examinations

Estimated Enrollment:	163
Study Start Date:	January 2003
Estimated Study Completion Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050830

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Locations

United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
Pfizer Investigational Site
Birmingham, Alabama, United States, 35294
Pfizer Investigational Site
Birmingham, Alabama, United States, 35924
United States, California
Pfizer Investigational Site
Greenbrae, California, United States, 94904
Pfizer Investigational Site
San Fransisco, California, United States, 94121
Pfizer Investigational Site
San Mateo, California, United States, 94402
Pfizer Investigational Site
San Pablo, California, United States, 94806
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Park Ridge, Illinois, United States, 60068
Pfizer Investigational Site
Skokie, Illinois, United States, 60076
United States, Indiana
Pfizer Investigational Site
Jefferson, Indiana, United States, 47130
United States, Kentucky
Pfizer Investigational Site
Crestview Hills, Kentucky, United States, 41017
Pfizer Investigational Site
LaGrange, Kentucky, United States, 40031
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
Pfizer Investigational Site
Louisville, Kentucky, United States, 40207
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02114
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48106
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
United States, North Carolina
Pfizer Investigational Site
Durham, North Carolina, United States, 27710
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45236
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
Pfizer Investigational Site
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Pfizer Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84112
United States, Wisconsin
Pfizer Investigational Site
Chippewa Falls, Wisconsin, United States, 54729
Pfizer Investigational Site
Eau Claire, Wisconsin, United States, 54701
Pfizer Investigational Site
Ladysmith, Wisconsin, United States, 54848
Pfizer Investigational Site
Marshfield, Wisconsin, United States, 54449
Pfizer Investigational Site
Marshfield, Wisconsin, United States, 54449-5277
Pfizer Investigational Site
Minocqua, Wisconsin, United States, 54548
Pfizer Investigational Site
Rice Lake, Wisconsin, United States, 54868
Pfizer Investigational Site
Stevens Point, Wisconsin, United States, 54481
Pfizer Investigational Site
Wausau, Wisconsin, United States, 54401
Pfizer Investigational Site
Wisconsin Rapids, Wisconsin, United States, 54494
Pfizer Investigational Site
Woodruff, Wisconsin, United States, 54568
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Germany
Pfizer Investigational Site
Gauting, Germany, 82131
Pfizer Investigational Site
Grosshansdorf, Germany, 22927
Pfizer Investigational Site
Heidelberg, Germany, 69126
Ireland
Pfizer Investigational Site
Cork, Ireland
Pfizer Investigational Site
Dublin, Ireland, 7
Italy
Pfizer Investigational Site
Bologna, Italy, 40139
Pfizer Investigational Site
Orbassano (Torino), Italy, 10043
Netherlands
Pfizer Investigational Site
Amsterdam, NH, Netherlands, 1081 HV
Spain
Pfizer Investigational Site
Hospitalet de Llobregat, Barcelona, Spain, 08907
United Kingdom
Pfizer Investigational Site
Glasgow, United Kingdom, G4 0SF
Pfizer Investigational Site
London, United Kingdom, SE1 9RT

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00050830 History of Changes
Other Study ID Numbers:	A4161003
Study First Received:	December 20, 2002
Last Updated:	November 6, 2006
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms

Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013