A Multicenter Phase 2 Study Of CI-1040 In Patients With Advanced Nonsmall-Cell Lung, Breast, Colon And Pancreatic Cancer

Study Overview

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

N/A

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

DRUG: CI-1040

1040-000-002

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2002-05-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2007-05-03
First Submitted that Met QC Criteria 2002-05-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2007-05-04
First Posted (ESTIMATED) 2002-05-03	Results First Posted N/A	Last Verified 2006-07

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Overall objective response and clinical benefit response

Secondary Outcome Measures	Measure Description	Time Frame
Time to objective response, duration of response, time to progression and survival

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

Unstable medical condition
prior chemotherapy within 4 week of screening
series infection
other tumor types
ECOG performance status of 3 or 4.

Collaborators and Investigators

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

Investigators

STUDY_DIRECTOR: Pfizer CT.gov Call Center, Pfizer

Publications

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

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record