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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050830
• Other study ID #: A4161003
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2002
• Last updated: November 6, 2006
• Start date: January 2003
• Est. completion date: November 2005

Study information

• Verified date: January 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• CI 1033

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Edmonton	Alberta
Canada	Pfizer Investigational Site	Montreal	Quebec
Germany	Pfizer Investigational Site	Gauting
Germany	Pfizer Investigational Site	Grosshansdorf
Germany	Pfizer Investigational Site	Heidelberg
Ireland	Pfizer Investigational Site	Cork
Ireland	Pfizer Investigational Site	Dublin
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Orbassano (Torino)
Netherlands	Pfizer Investigational Site	Amsterdam	NH
Spain	Pfizer Investigational Site	Hospitalet de Llobregat	Barcelona
United Kingdom	Pfizer Investigational Site	Glasgow
United Kingdom	Pfizer Investigational Site	London
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Ann Arbor	Michigan
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Chippewa Falls	Wisconsin
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Eau Claire	Wisconsin
United States	Pfizer Investigational Site	Greenbrae	California
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jefferson	Indiana
United States	Pfizer Investigational Site	Ladysmith	Wisconsin
United States	Pfizer Investigational Site	LaGrange	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Marshfield	Wisconsin
United States	Pfizer Investigational Site	Marshfield	Wisconsin
United States	Pfizer Investigational Site	Minocqua	Wisconsin
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Park Ridge	Illinois
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Rice Lake	Wisconsin
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	San Fransisco	California
United States	Pfizer Investigational Site	San Mateo	California
United States	Pfizer Investigational Site	San Pablo	California
United States	Pfizer Investigational Site	Skokie	Illinois
United States	Pfizer Investigational Site	Stevens Point	Wisconsin
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Wausau	Wisconsin
United States	Pfizer Investigational Site	Wisconsin Rapids	Wisconsin
United States	Pfizer Investigational Site	Woodruff	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Ireland,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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