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A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer

Primary Purpose

Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CI-1040
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

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

Inclusion Criteria: Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer. No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer. Original or recent tumor tissue must be available. Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks. Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor). Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug. Exclusion Criteria: Unstable medical condition prior chemotherapy within 4 week of screening series infection other tumor types ECOG performance status of 3 or 4.

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

Outcomes

Primary Outcome Measures

Overall objective response and clinical benefit response

Secondary Outcome Measures

Time to objective response, duration of response, time to progression and survival

Full Information

First Posted
May 2, 2002
Last Updated
May 3, 2007
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00034827
Brief Title
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer
Official Title
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer, or Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

Brief Summary
CI-1040 is an experimental drug that is being tested in patients who have advanced colorectal and lung cancer who failed no more than one prior chemotherapy regimen, breast cancer who have failed no more than 2 prior regimens and in patients with pancreatic cancer who have received no prior chemotherapy. CI-1040 is taken orally twice daily with meals. Patients are required to have blood tests periodically while receiving treatment and will be monitored closely throughout the trial for possible side effects and for response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
172 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
CI-1040
Primary Outcome Measure Information:
Title
Overall objective response and clinical benefit response
Secondary Outcome Measure Information:
Title
Time to objective response, duration of response, time to progression and survival

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are at least 18 years or older who have pathological or hiostological confirmation of colorectal, nonsmall cell lung cancer, breast, or pancreas cancer. No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast no prior chemotherapy for pancreas cancer. Original or recent tumor tissue must be available. Patients must have been off prior chemoptherapy for 4 weeks and radiation for 3 weeks. Patients must have adequate renal, liver, and bone marrow function, not have serious infection or life-threatening illness (unrelated to tumor). Must be able to swallow capsules and not have gastrointestinal disorders that may affect absorption of the drug. Exclusion Criteria: Unstable medical condition prior chemotherapy within 4 week of screening series infection other tumor types ECOG performance status of 3 or 4.
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
35205
Country
United States
Facility Name
Pfizer Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Pfizer Investigational Site
City
Blendora
State/Province
California
ZIP/Postal Code
91740
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Pfizer Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pfizer Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Pfizer Investigational Site
City
Northridge
State/Province
California
ZIP/Postal Code
91328
Country
United States
Facility Name
Pfizer Investigational Site
City
Oxnard
State/Province
California
ZIP/Postal Code
93030
Country
United States
Facility Name
Pfizer Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Pfizer Investigational Site
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Pfizer Investigational Site
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
Pfizer Investigational Site
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Pfizer Investigational Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Pfizer Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Pfizer Investigational Site
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Pfizer Investigational Site
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Pfizer Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Pfizer Investigational Site
City
Macon
State/Province
Georgia
ZIP/Postal Code
30342
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
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnait
State/Province
Ohio
ZIP/Postal Code
45236
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
45230
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=1040-000-002&StudyName=A+Multicenter+Phase+2+Study+of+CI%2D1040+in+Patients+with+Advanced+Nonsmall%2DCell+Lung%2C+Breast%2C+Colon+and+Pancreatic+Cancer
Description
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Learn more about this trial

A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer

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