Colorectal NeoplasmsPhase 2NCT00034827
A Multicenter Phase 2 Study of CI-1040 in Patients With Advanced Nonsmall-Cell Lung, Breast, Colon and Pancreatic Cancer
A Phase 2 study testing CI-1040 in people with Colorectal Neoplasms and Breast Neoplasms, run by Pfizer at 30 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung
- What is being tested?
- CI-1040
- How many people
- 172 participants
- Where
- 30 sitesUnited States
- Study dates
- Jan 2002to May 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Unstable medical condition
- prior chemotherapy within 4 week of screening
- series infection
- other tumor types
- ECOG performance status of 3 or 4.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Birmingham, Alabama, 35205
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Blendora, California, 91740
Pfizer Investigational Site
Cincinnait, Ohio, 45236
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45230
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Decatur, Georgia, 30033
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Glendale, California, 91204
Pfizer Investigational Site
Huntington Beach, California, 92648
Pfizer Investigational Site
Long Beach, California, 90813
Pfizer Investigational Site
Los Alamitos, California, 90720
Pfizer Investigational Site
Los Angeles, California, 90048
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Macon, Georgia, 30342
Pfizer Investigational Site
Mission Hills, California, 91345
Pfizer Investigational Site
Northridge, California, 91328
Pfizer Investigational Site
Oxnard, California, 93030
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Pomona, California, 91767
Pfizer Investigational Site
Rancho Cucamonga, California, 91730
Pfizer Investigational Site
Redondo Beach, California, 90277
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Torrance, California, 90505
Pfizer Investigational Site
Ventura, California, 93003
Pfizer Investigational Site
West Covina, California, 91790
About this study
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
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.
- Conditions
- Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
- Being tested
- CI-1040
- Medical subject headings
- Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI-1040Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall objective response and clinical benefit response
Secondary outcomes (1)
Time to objective response, duration of response, time to progression and survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startJan 2002
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 172 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034827
- Sponsor's protocol ID
- 1040-000-002
- Status last verified
- Jul 2006
- First submitted
- 2 May 2002
- Last updated
- 4 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00034827
- Acronym / sponsor ID
- 1040-000-002
- Conditions
- Colorectal Neoplasms, Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Study completion
- May 2003 (actual)
- First posted
- 3 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- Unstable medical condition
- prior chemotherapy within 4 week of screening
- series infection
- other tumor types
- ECOG performance status of 3 or 4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CI-1040 | Drug | – |
Primary outcome
Overall objective response and clinical benefit response
1 secondary outcome
Time to objective response, duration of response, time to progression and survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2007.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CI-1040 in people with Colorectal Neoplasms and Breast Neoplasms, run by Pfizer at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall objective response and clinical benefit response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2007.