- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00034827
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer
May 3, 2007 updated by: Pfizer
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung Cancer, Breast Cancer, Colon Cancer, or Pancreatic Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
172
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35205
- Pfizer Investigational Site
-
Birmingham, Alabama, United States, 35233
- Pfizer Investigational Site
-
-
California
-
Blendora, California, United States, 91740
- Pfizer Investigational Site
-
Glendale, California, United States, 91204
- Pfizer Investigational Site
-
Huntington Beach, California, United States, 92648
- Pfizer Investigational Site
-
Long Beach, California, United States, 90813
- Pfizer Investigational Site
-
Los Alamitos, California, United States, 90720
- Pfizer Investigational Site
-
Los Angeles, California, United States, 90095
- Pfizer Investigational Site
-
Los Angeles, California, United States, 90048
- Pfizer Investigational Site
-
Mission Hills, California, United States, 91345
- Pfizer Investigational Site
-
Northridge, California, United States, 91328
- Pfizer Investigational Site
-
Oxnard, California, United States, 93030
- Pfizer Investigational Site
-
Pasadena, California, United States, 91105
- Pfizer Investigational Site
-
Pomona, California, United States, 91767
- Pfizer Investigational Site
-
Rancho Cucamonga, California, United States, 91730
- Pfizer Investigational Site
-
Redondo Beach, California, United States, 90277
- Pfizer Investigational Site
-
Santa Monica, California, United States, 90404
- Pfizer Investigational Site
-
Torrance, California, United States, 90505
- Pfizer Investigational Site
-
Ventura, California, United States, 93003
- Pfizer Investigational Site
-
West Covina, California, United States, 91790
- Pfizer Investigational Site
-
-
Georgia
-
Atlanta, Georgia, United States, 30342
- Pfizer Investigational Site
-
Decatur, Georgia, United States, 30033
- Pfizer Investigational Site
-
Macon, Georgia, United States, 30342
- Pfizer Investigational Site
-
-
Kentucky
-
Crestview Hills, Kentucky, United States, 41017
- Pfizer Investigational Site
-
-
Michigan
-
Detroit, Michigan, United States, 48201
- Pfizer Investigational Site
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Pfizer Investigational Site
-
-
Ohio
-
Cincinnait, Ohio, United States, 45236
- Pfizer Investigational Site
-
Cincinnati, Ohio, United States, 45242
- Pfizer Investigational Site
-
Cincinnati, Ohio, United States, 45219
- Pfizer Investigational Site
-
Cincinnati, Ohio, United States, 45230
- Pfizer Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall objective response and clinical benefit response
|
Secondary Outcome Measures
Outcome Measure |
---|
Time to objective response, duration of response, time to progression and survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Study Completion (Actual)
May 1, 2003
Study Registration Dates
First Submitted
May 2, 2002
First Submitted That Met QC Criteria
May 2, 2002
First Posted (Estimate)
May 3, 2002
Study Record Updates
Last Update Posted (Estimate)
May 4, 2007
Last Update Submitted That Met QC Criteria
May 3, 2007
Last Verified
July 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Endocrine Gland Neoplasms
- Breast Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Lung Neoplasms
- Pancreatic Diseases
- Neoplasms
- Breast Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Colorectal Neoplasms
- Pancreatic Neoplasms
Other Study ID Numbers
- 1040-000-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Neoplasms
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
-
Emory UniversityEisai Inc.TerminatedBreast Cancer | Breast Neoplasms | Breast Tumors | Neoplasms, Breast | Cancer of the Breast | Tumors, BreastUnited States
-
Seagen Inc.CompletedTriple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast NeoplasmsUnited States
-
Providence Health & ServicesBrooklyn ImmunoTherapeutics, LLCActive, not recruitingBreast Neoplasm | Triple Negative Breast Cancer | Breast Neoplasm, MaleUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Celgene CorporationTerminatedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
-
BerGenBio ASAMerck Sharp & Dohme LLCTerminatedTriple Negative Breast Cancer | Inflammatory Breast Cancer Stage IVSpain, United States, United Kingdom, Norway
-
CytomX TherapeuticsCompletedNeoplasms | Breast Cancer | Breast Neoplasms | Breast Neoplasms, Triple-Negative | Breast Neoplasms, Hormone Receptor Positive/HER2 NegativeUnited States, Spain, Korea, Republic of
-
University of WashingtonNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Dana-Farber Cancer InstituteConquer Cancer FoundationRecruitingBreast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | HER2-positive Breast Cancer | Inflammatory Breast Cancer | Hormone Receptor Positive Malignant Neoplasm of BreastUnited States
Clinical Trials on CI-1040
-
University of Alabama at BirminghamNational Cancer Institute (NCI)CompletedBreast Cancer | Colorectal Cancer | Pancreatic Cancer | Lung CancerUnited States
-
BioLineRx, Ltd.Sheba Medical CenterUnknown
-
Universitair Ziekenhuis BrusselRecruitingSensorineural Hearing Loss | Cochlear ImplantsBelgium
-
HealthPartners InstituteNational Institute on Aging (NIA); OCHIN, Inc.RecruitingCognitive Impairment | DementiaUnited States
-
University of MiamiCochlearCompleted
-
Matthew Bush, MDCompletedHearing Loss | Hearing DisordersUnited States
-
Ohio State UniversityActive, not recruitingStroke | HemiparesisUnited States
-
Ohio State UniversityUniversity of Missouri-Columbia; University of Alabama at Birmingham; University... and other collaboratorsCompletedEffectiveness of Virtual Reality Gaming Therapy Versus CI Therapy for Upper Extremity RehabilitationStroke | HemiparesisUnited States
-
MED-EL Elektromedizinische Geräte GesmbHRecruiting
-
George Papanicolaou HospitalNot yet recruitingCoronary Artery Disease | Aortic Valve Disease | Mitral Valve Disease