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

Phase 2

Completed

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

• Registration Number: NCT00034827
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2002-05-02
• Study First Submitted QC: 2002-05-02
• Study First Posted: 2002-05-03
• Study Completion: 2003-05
• Status Verified: 2006-07
• Last Update Submitted: 2007-05-03
• Last Update Posted: 2007-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall objective response and clinical benefit response

Secondary Outcome Measures

Name	Time	Method
Time to objective response, duration of response, time to progression and survival

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Cincinnati, Ohio, United States