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

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NCT00034827

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Colorectal Neoplasms, Breast Neoplasms, Non-Small-Cell Lung Carcinoma, Pancreatic Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Unstable medical condition


- prior chemotherapy within 4 week of screening


- series infection


- other tumor types


- ECOG performance status of 3 or 4.

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Colorectal Neoplasms, Breast Neoplasms, Non-Small-Cell Lung Carcinoma, Pancreatic NeoplasmsA Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer
NCT00034827
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Blendora, California
  4. Glendale, California
  5. Huntington Beach, California
  6. Long Beach, California
  7. Los Alamitos, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Mission Hills, California
  11. Northridge, California
  12. Oxnard, California
  13. Pasadena, California
  14. Pomona, California
  15. Rancho Cucamonga, California
  16. Redondo Beach, California
  17. Santa Monica, California
  18. Torrance, California
  19. Ventura, California
  20. West Covina, California
  21. Atlanta, Georgia
  22. Decatur, Georgia
  23. Macon, Georgia
  24. Crestview Hills, Kentucky
  25. Detroit, Michigan
  26. Rochester, Minnesota
  27. Cincinnait, Ohio
  28. Cincinnati, Ohio
  29. Cincinnati, Ohio
  30. Cincinnati, Ohio
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer
Official Title  ICMJE A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer, or Pancreatic Cancer
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Neoplasms
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Pancreatic Neoplasms
Intervention  ICMJE Drug: CI-1040
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)		172
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00034827
Other Study ID Numbers  ICMJE 1040-000-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2006

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