A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer
1 other identifier
interventional
172
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2002
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
May 2, 2002
CompletedFirst Posted
Study publicly available on registry
May 3, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2003
CompletedMay 4, 2007
July 1, 2006
May 2, 2002
May 3, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Overall objective response and clinical benefit response
Secondary Outcomes (1)
Time to objective response, duration of response, time to progression and survival
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Unstable medical condition
- prior chemotherapy within 4 week of screening
- series infection
- other tumor types
- ECOG performance status of 3 or 4.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (30)
Pfizer Investigational Site
Birmingham, Alabama, 35205, United States
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Pfizer Investigational Site
Blendora, California, 91740, United States
Pfizer Investigational Site
Glendale, California, 91204, United States
Pfizer Investigational Site
Huntington Beach, California, 92648, United States
Pfizer Investigational Site
Long Beach, California, 90813, United States
Pfizer Investigational Site
Los Alamitos, California, 90720, United States
Pfizer Investigational Site
Los Angeles, California, 90048, United States
Pfizer Investigational Site
Los Angeles, California, 90095, United States
Pfizer Investigational Site
Mission Hills, California, 91345, United States
Pfizer Investigational Site
Northridge, California, 91328, United States
Pfizer Investigational Site
Oxnard, California, 93030, United States
Pfizer Investigational Site
Pasadena, California, 91105, United States
Pfizer Investigational Site
Pomona, California, 91767, United States
Pfizer Investigational Site
Rancho Cucamonga, California, 91730, United States
Pfizer Investigational Site
Redondo Beach, California, 90277, United States
Pfizer Investigational Site
Santa Monica, California, 90404, United States
Pfizer Investigational Site
Torrance, California, 90505, United States
Pfizer Investigational Site
Ventura, California, 93003, United States
Pfizer Investigational Site
West Covina, California, 91790, United States
Pfizer Investigational Site
Atlanta, Georgia, 30342, United States
Pfizer Investigational Site
Decatur, Georgia, 30033, United States
Pfizer Investigational Site
Macon, Georgia, 30342, United States
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017, United States
Pfizer Investigational Site
Detroit, Michigan, 48201, United States
Pfizer Investigational Site
Rochester, Minnesota, 55905, United States
Pfizer Investigational Site
Cincinnait, Ohio, 45236, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45219, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45230, United States
Pfizer Investigational Site
Cincinnati, Ohio, 45242, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2002
First Posted
May 3, 2002
Study Start
January 1, 2002
Study Completion
May 1, 2003
Last Updated
May 4, 2007
Record last verified: 2006-07