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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034827
• Other study ID #: 1040-000-002
• Status: Completed
• Phase: Phase 2
• First received: May 2, 2002
• Last updated: May 3, 2007
• Start date: January 2002
• Est. completion date: May 2003

Study information

• Verified date: July 2006
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• CI-1040

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Birmingham	Alabama
United States	Pfizer Investigational Site	Blendora	California
United States	Pfizer Investigational Site	Cincinnait	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Crestview Hills	Kentucky
United States	Pfizer Investigational Site	Decatur	Georgia
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Glendale	California
United States	Pfizer Investigational Site	Huntington Beach	California
United States	Pfizer Investigational Site	Long Beach	California
United States	Pfizer Investigational Site	Los Alamitos	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Macon	Georgia
United States	Pfizer Investigational Site	Mission Hills	California
United States	Pfizer Investigational Site	Northridge	California
United States	Pfizer Investigational Site	Oxnard	California
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Pomona	California
United States	Pfizer Investigational Site	Rancho Cucamonga	California
United States	Pfizer Investigational Site	Redondo Beach	California
United States	Pfizer Investigational Site	Rochester	Minnesota
United States	Pfizer Investigational Site	Santa Monica	California
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Ventura	California
United States	Pfizer Investigational Site	West Covina	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall objective response and clinical benefit response
Secondary	Time to objective response, duration of response, time to progression and survival

External Links

•   To obtain contact information for a study center near you, click here.