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A multicenter phase 2 study of CI-1040 in patients with advanced nonsmall-cell lung cancer, breast cancer, colon cancer, or pancreatic cancer



A multicenter phase 2 study of CI-1040 in patients with advanced nonsmall-cell lung cancer, breast cancer, colon cancer, or pancreatic cancer

For Condition: Carcinoma, Non-Small-Cell Lung,Pancreatic Neoplasms,Colorectal Neoplasms,Breast Neoplasms
Status: Completed
Sponsor(s): Pfizer ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Patients who are at least 18 years or older who have pathological or histological confirmation of colorectal, nonsmall-cell lung, breast or pancreas cancer. - No more than 1 prior chemo for lung or colon cancer, no more than 2 for breast and no prior chemotherapy for pancreas cancer. - Original or recent tumor tissue must be available. - Patients must have been off prior chemotherapy 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.
Total Enrollment: 172

Location and Contact Information:

Cedars-Sinai Comprehensive Cancer Center
Los Angeles,  California,  90048-1804
United States
 

263 Wallace Tumor Institute
Birmingham,  Alabama,  35294
United States
 

Mayo Clinic
Rochester,  Minnesota,  55905
United States
 

Oncology Hematology Care, Inc
Cincinnati,  Ohio,  45236
United States
 

UCLA School of Medicine
Los Angeles,  California,  90095
United States
 

Harper Hospital
Detroit,  Michigan,  48201
United States
 


Additional Information:
Study ID Numbers:
  1040-000-002; 
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034827

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