Lung NeoplasmsPhase 2NCT00050830
A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing CI 1033 in people with Lung Neoplasms, run by Pfizer at 57 sites in 8 countries.
Trial summary
The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- CI 1033
- How many people
- 163 participants
- Where
- 57 sitesin 8 countries
- Study dates
- Jan 2003to Nov 2005
- 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
- Histologically or cytologically documented diagnosis of progressive or recurrent, locally advanced or metastatic NSCLC; a tumor that expresses at least one member of the erbB family of receptors; failed or relapsed after receiving a platinum-containing regimen as therapy; at least one measurable target lesion as defined by RECIST that has not been irradiated.
Who cannot join
- Prior exposure to agents that target the erbB receptor family; unknown response to prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2 weeks prior to baseline disease assessment; prior irradiation to areas encompassing greater than 30% of marrow-bearing bone; brain metastases.
Trial locations and contacts
57 sites in 8 countries.
57 sites in 8 countries
United States44 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Birmingham, Alabama, 35924
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Chicago, Illinois, 60637
Pfizer Investigational Site
Chippewa Falls, Wisconsin, 54729
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Cincinnati, Ohio, 45236
Pfizer Investigational Site
Cincinnati, Ohio, 45242
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Eau Claire, Wisconsin, 54701
Pfizer Investigational Site
Greenbrae, California, 94904
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jefferson, Indiana, 47130
Pfizer Investigational Site
La Grange, Kentucky, 40031
Pfizer Investigational Site
Ladysmith, Wisconsin, 54848
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Louisville, Kentucky, 40217
Pfizer Investigational Site
Marshfield, Wisconsin, 54449-5277
Pfizer Investigational Site
Marshfield, Wisconsin, 54449
Pfizer Investigational Site
Minocqua, Wisconsin, 54548
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
Rice Lake, Wisconsin, 54868
Pfizer Investigational Site
Salt Lake City, Utah, 84112
Pfizer Investigational Site
San Francisco, California, 94121
Pfizer Investigational Site
San Mateo, California, 94402
Pfizer Investigational Site
San Pablo, California, 94806
Pfizer Investigational Site
Skokie, Illinois, 60076
Pfizer Investigational Site
Stevens Point, Wisconsin, 54481
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
Wausau, Wisconsin, 54401
Pfizer Investigational Site
Wisconsin Rapids, Wisconsin, 54494
Pfizer Investigational Site
Woodruff, Wisconsin, 54568
Germany3 sites
Pfizer Investigational Site
Gauting, 82131
Pfizer Investigational Site
Großhansdorf, 22927
Pfizer Investigational Site
Heidelberg, 69126
Canada2 sites
Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Ireland2 sites
Pfizer Investigational Site
Cork
Pfizer Investigational Site
Dublin, 7
Italy2 sites
Pfizer Investigational Site
Bologna, 40139
Pfizer Investigational Site
Orbassano (Torino), 10043
United Kingdom2 sites
Pfizer Investigational Site
Glasgow, G4 0SF
Pfizer Investigational Site
London, SE1 9RT
Netherlands1 site
Pfizer Investigational Site
Amsterdam, North Holland, 1081 HV
Spain1 site
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.
- Conditions
- Lung Neoplasms
- Being tested
- CI 1033
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI 1033Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy
Secondary outcomes (1)
Secondary objectives also include determining the safety of CI 1033 and the detection of any correlations between baseline tumor erbB expression and efficacy. Safety will be assessed by spontaneous AE reporting, physical examinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2002 (estimated)
- Study startJan 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 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
- NCT00050830
- Sponsor's protocol ID
- A4161003
- Status last verified
- Jan 2006
- First submitted
- 20 Dec 2002
- Last updated
- 8 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00050830
- Acronym / sponsor ID
- A4161003
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- Study completion
- Nov 2005
- First posted
- 24 Dec 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.
The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (1 listed)
- Histologically or cytologically documented diagnosis of progressive or recurrent, locally advanced or metastatic NSCLC; a tumor that expresses at least one member of the erbB family of receptors; failed or relapsed after receiving a platinum-containing regimen as therapy; at least one measurable target lesion as defined by RECIST that has not been irradiated.
Key exclusion criteria (1 listed)
- Prior exposure to agents that target the erbB receptor family; unknown response to prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2 weeks prior to baseline disease assessment; prior irradiation to areas encompassing greater than 30% of marrow-bearing bone; brain metastases.
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 1033 | Drug | – |
Primary outcome
The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy
1 secondary outcome
Secondary objectives also include determining the safety of CI 1033 and the detection of any correlations between baseline tumor erbB expression and efficacy. Safety will be assessed by spontaneous AE reporting, physical examinations
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 8 Nov 2006.
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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
57 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CI 1033 in people with Lung Neoplasms, run by Pfizer at 57 sites in 8 countries.
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 1 inclusion and 1 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 8 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Germany, Canada, Ireland, Italy and 3 more countries. 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?
The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy. 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 8 Nov 2006.