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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall objective response and clinical benefit response

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

1040-000-002

NCT ID:

NCT00034827

Start Date:

January 2002

Completion Date:

May 2003

Related Keywords:

  • Colorectal Neoplasms
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Pancreatic Neoplasms
  • Breast Neoplasms
  • Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Neoplasms
  • Pancreatic Neoplasms

Name

Location

Pfizer Investigational Site Birmingham, Alabama  35205
Pfizer Investigational Site Blendora, California  91740
Pfizer Investigational Site Atlanta, Georgia  30342
Pfizer Investigational Site Crestview Hills, Kentucky  41017
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Rochester, Minnesota  55905
Pfizer Investigational Site Cincinnait, Ohio  45236