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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

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CI 1033
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
December 20, 2002
Last Updated
November 6, 2006
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00050830
Brief Title
A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
Official Title
A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
163 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CI 1033
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35924
Country
United States
Facility Name
Pfizer Investigational Site
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Pfizer Investigational Site
City
San Fransisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Pfizer Investigational Site
City
San Mateo
State/Province
California
ZIP/Postal Code
94402
Country
United States
Facility Name
Pfizer Investigational Site
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Pfizer Investigational Site
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Pfizer Investigational Site
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Pfizer Investigational Site
City
Jefferson
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Pfizer Investigational Site
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Pfizer Investigational Site
City
LaGrange
State/Province
Kentucky
ZIP/Postal Code
40031
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Pfizer Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Pfizer Investigational Site
City
Chippewa Falls
State/Province
Wisconsin
ZIP/Postal Code
54729
Country
United States
Facility Name
Pfizer Investigational Site
City
Eau Claire
State/Province
Wisconsin
ZIP/Postal Code
54701
Country
United States
Facility Name
Pfizer Investigational Site
City
Ladysmith
State/Province
Wisconsin
ZIP/Postal Code
54848
Country
United States
Facility Name
Pfizer Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449-5277
Country
United States
Facility Name
Pfizer Investigational Site
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Pfizer Investigational Site
City
Minocqua
State/Province
Wisconsin
ZIP/Postal Code
54548
Country
United States
Facility Name
Pfizer Investigational Site
City
Rice Lake
State/Province
Wisconsin
ZIP/Postal Code
54868
Country
United States
Facility Name
Pfizer Investigational Site
City
Stevens Point
State/Province
Wisconsin
ZIP/Postal Code
54481
Country
United States
Facility Name
Pfizer Investigational Site
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States
Facility Name
Pfizer Investigational Site
City
Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
Country
United States
Facility Name
Pfizer Investigational Site
City
Woodruff
State/Province
Wisconsin
ZIP/Postal Code
54568
Country
United States
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Pfizer Investigational Site
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Pfizer Investigational Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Pfizer Investigational Site
City
Cork
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Dublin
ZIP/Postal Code
7
Country
Ireland
Facility Name
Pfizer Investigational Site
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Orbassano (Torino)
ZIP/Postal Code
10043
Country
Italy
Facility Name
Pfizer Investigational Site
City
Amsterdam
State/Province
NH
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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