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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.
Study NCT00034827   Information provided by Pfizer
First Received: May 2, 2002   Last Updated: May 3, 2007   History of Changes

May 2, 2002
May 3, 2007
January 2002
 
Overall objective response and clinical benefit response
Same as current
Complete list of historical versions of study NCT00034827 on ClinicalTrials.gov Archive Site
Time to objective response, duration of response, time to progression and survival
Same as current
 
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and 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

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.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  • Colorectal Neoplasms
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Pancreatic Neoplasms
Drug: CI-1040
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
172
May 2003
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00034827
 
1040-000-002
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP