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

NCT00050830 | Completed Phase 2

• 1 other identifier: A4161003
• Study Type: interventional
• Target: 163
• Locations: 8 countries
• Sites: 57

Brief Summary

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.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

CI 1033 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (57)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35294, United States

Location

Pfizer Investigational Site

Birmingham, Alabama, 35924, United States

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Pfizer Investigational Site

Greenbrae, California, 94904, United States

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Pfizer Investigational Site

San Francisco, California, 94121, United States

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Pfizer Investigational Site

San Mateo, California, 94402, United States

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Pfizer Investigational Site

San Pablo, California, 94806, United States

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Pfizer Investigational Site

Tampa, Florida, 33612, United States

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Pfizer Investigational Site

Chicago, Illinois, 60612, United States

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Pfizer Investigational Site

Chicago, Illinois, 60637, United States

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Pfizer Investigational Site

Park Ridge, Illinois, 60068, United States

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Pfizer Investigational Site

Skokie, Illinois, 60076, United States

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Pfizer Investigational Site

Jefferson, Indiana, 47130, United States

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Pfizer Investigational Site

Crestview Hills, Kentucky, 41017, United States

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Pfizer Investigational Site

La Grange, Kentucky, 40031, United States

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Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

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Pfizer Investigational Site

Louisville, Kentucky, 40207, United States

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Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

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Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

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Pfizer Investigational Site

Ann Arbor, Michigan, 48106, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

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Pfizer Investigational Site

New York, New York, 10032, United States

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Pfizer Investigational Site

Durham, North Carolina, 27710, United States

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Pfizer Investigational Site

Cincinnati, Ohio, 45219, United States

Location

Pfizer Investigational Site

Cincinnati, Ohio, 45236, United States

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Pfizer Investigational Site

Cincinnati, Ohio, 45242, United States

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Pfizer Investigational Site

Columbus, Ohio, 43210, United States

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Pfizer Investigational Site

Philadelphia, Pennsylvania, 19111, United States

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Pfizer Investigational Site

Nashville, Tennessee, 37203, United States

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Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

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Pfizer Investigational Site

Houston, Texas, 77030, United States

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Pfizer Investigational Site

Salt Lake City, Utah, 84112, United States

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Pfizer Investigational Site

Chippewa Falls, Wisconsin, 54729, United States

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Pfizer Investigational Site

Eau Claire, Wisconsin, 54701, United States

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Pfizer Investigational Site

Ladysmith, Wisconsin, 54848, United States

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Pfizer Investigational Site

Marshfield, Wisconsin, 54449-5277, United States

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Pfizer Investigational Site

Marshfield, Wisconsin, 54449, United States

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Pfizer Investigational Site

Minocqua, Wisconsin, 54548, United States

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Pfizer Investigational Site

Rice Lake, Wisconsin, 54868, United States

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Pfizer Investigational Site

Stevens Point, Wisconsin, 54481, United States

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Pfizer Investigational Site

Wausau, Wisconsin, 54401, United States

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Pfizer Investigational Site

Wisconsin Rapids, Wisconsin, 54494, United States

Location

Pfizer Investigational Site

Woodruff, Wisconsin, 54568, United States

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Pfizer Investigational Site

Edmonton, Alberta, T6G 1Z2, Canada

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Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

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Pfizer Investigational Site

Gauting, 82131, Germany

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Pfizer Investigational Site

Großhansdorf, 22927, Germany

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Pfizer Investigational Site

Heidelberg, 69126, Germany

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Pfizer Investigational Site

Cork, Ireland

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Pfizer Investigational Site

Dublin, 7, Ireland

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Pfizer Investigational Site

Bologna, 40139, Italy

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Pfizer Investigational Site

Orbassano (Torino), 10043, Italy

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Pfizer Investigational Site

Amsterdam, North Holland, 1081 HV, Netherlands

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Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Pfizer Investigational Site

Glasgow, G4 0SF, United Kingdom

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Pfizer Investigational Site

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Canertinib

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 20, 2002
• First Posted: December 24, 2002
• Study Start: January 1, 2003
• Study Completion: November 1, 2005
• Last Updated: November 8, 2006

Record last verified: 2006-01

Locations

IE (2); US (44); NL (1); GB (2); DE (3); ES (1); IT (2); CA (2)