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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00034827
First received: May 2, 2002
Last updated: May 3, 2007
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Drug: CI-1040
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 172
Study Start Date: January 2002
Study Completion Date: May 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034827

Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
United States, California
Pfizer Investigational Site
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, 90048
Pfizer Investigational Site
Los Angeles, California, United States, 90095
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
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Decatur, Georgia, United States, 30033
Pfizer Investigational Site
Macon, Georgia, United States, 30342
United States, Kentucky
Pfizer Investigational Site
Crestview Hills, Kentucky, United States, 41017
United States, Michigan
Pfizer Investigational Site
Detroit, Michigan, United States, 48201
United States, Minnesota
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, Ohio
Pfizer Investigational Site
Cincinnait, Ohio, United States, 45236
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45242
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45230
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00034827     History of Changes
Other Study ID Numbers: 1040-000-002
Study First Received: May 2, 2002
Last Updated: May 3, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Pancreatic Neoplasms
Breast Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Breast Diseases
Skin Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 30, 2014