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

May 3, 2007 updated by: Pfizer

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

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.

Study Overview

Study Type

Interventional

Enrollment

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
    • California
      • Blendora, California, United States, 91740
        • Pfizer Investigational Site
      • Glendale, California, United States, 91204
        • Pfizer Investigational Site
      • Huntington Beach, California, United States, 92648
        • Pfizer Investigational Site
      • Long Beach, California, United States, 90813
        • Pfizer Investigational Site
      • Los Alamitos, California, United States, 90720
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90048
        • Pfizer Investigational Site
      • Mission Hills, California, United States, 91345
        • Pfizer Investigational Site
      • Northridge, California, United States, 91328
        • Pfizer Investigational Site
      • Oxnard, California, United States, 93030
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91105
        • Pfizer Investigational Site
      • Pomona, California, United States, 91767
        • Pfizer Investigational Site
      • Rancho Cucamonga, California, United States, 91730
        • Pfizer Investigational Site
      • Redondo Beach, California, United States, 90277
        • Pfizer Investigational Site
      • Santa Monica, California, United States, 90404
        • Pfizer Investigational Site
      • Torrance, California, United States, 90505
        • Pfizer Investigational Site
      • Ventura, California, United States, 93003
        • Pfizer Investigational Site
      • West Covina, California, United States, 91790
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Decatur, Georgia, United States, 30033
        • Pfizer Investigational Site
      • Macon, Georgia, United States, 30342
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Pfizer Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Pfizer Investigational Site
    • Ohio
      • Cincinnait, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45230
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall objective response and clinical benefit response

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Study Completion (Actual)

May 1, 2003

Study Registration Dates

First Submitted

May 2, 2002

First Submitted That Met QC Criteria

May 2, 2002

First Posted (Estimate)

May 3, 2002

Study Record Updates

Last Update Posted (Estimate)

May 4, 2007

Last Update Submitted That Met QC Criteria

May 3, 2007

Last Verified

July 1, 2006

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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