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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00034827
First received: May 2, 2002
Last updated: May 3, 2007
Last verified: July 2006
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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:
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
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, 45219 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45230 | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45242 | |
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:
|
Breast Neoplasms Neoplasms Carcinoma Carcinoma, Non-Small-Cell Lung Colorectal Neoplasms Pancreatic Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Endocrine Gland Neoplasms Pancreatic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013