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

NCT ID: NCT00034827

Last Updated: 2007-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2003-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CI-1040

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Birmingham, Alabama, United States

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Pfizer Investigational Site

Blendora, California, United States

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Pfizer Investigational Site

Glendale, California, United States

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Pfizer Investigational Site

Huntington Beach, California, United States

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Pfizer Investigational Site

Long Beach, California, United States

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Pfizer Investigational Site

Los Alamitos, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Mission Hills, California, United States

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Pfizer Investigational Site

Northridge, California, United States

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Pfizer Investigational Site

Oxnard, California, United States

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Pfizer Investigational Site

Pasadena, California, United States

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Pfizer Investigational Site

Pomona, California, United States

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Pfizer Investigational Site

Rancho Cucamonga, California, United States

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Pfizer Investigational Site

Redondo Beach, California, United States

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Pfizer Investigational Site

Santa Monica, California, United States

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Pfizer Investigational Site

Torrance, California, United States

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Pfizer Investigational Site

Ventura, California, United States

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Pfizer Investigational Site

West Covina, California, United States

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Pfizer Investigational Site

Atlanta, Georgia, United States

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Pfizer Investigational Site

Decatur, Georgia, United States

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Pfizer Investigational Site

Macon, Georgia, United States

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Pfizer Investigational Site

Crestview Hills, Kentucky, United States

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Pfizer Investigational Site

Detroit, Michigan, United States

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Pfizer Investigational Site

Rochester, Minnesota, United States

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Pfizer Investigational Site

Cincinnait, Ohio, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

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Pfizer Investigational Site

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Related Links

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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

To obtain contact information for a study center near you, click here.

Other Identifiers

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1040-000-002

Identifier Type: -

Identifier Source: org_study_id