Breast NeoplasmsPhase 2NCT00051051
A Phase II Study of CI-1033 in Treating Patients With Metastatic (Stage IV) Breast Cancer
A Phase 2 study testing CI-1033 in people with Breast Neoplasms, run by Pfizer at 66 sites in 9 countries.
Trial summary
CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- CI-1033
- How many people
- 168 participants
- Where
- 66 sitesin 9 countries
- Study dates
- Dec 2002to May 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, at least 18 years of age
- Histologically confirmed diagnosis of breast cancer
- Metastatic (Stage IV) disease
- Progressive or recurrent disease following the most recent therapy
- No more than 2 different, prior cytotoxic chemotherapy regimens for metastatic disease
- At least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) that has not been irradiated
Show all 24Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, determined within 2 weeks prior to randomization
- Estimated life expectancy of > 12 weeks
- Capable of giving written informed consent
- Capable of swallowing intact CI-1033 capsules
- Capable of understanding and adhering to the protocol requirements
- No prior exposure to CI-1033 or other agents that target the erbB receptor family (such as Herceptin, Iressa, Tarceva, IMC-C225, and EKB-569)
- No known hypersensitivity reaction to tyrosine kinase inhibitors
- Adequate liver, renal, or bone marrow function determined within 2 weeks prior to randomization
- No cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin)
- No immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments
- No hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments (6 weeks for megestrol acetate)
- Patients must have recovered from the acute effects of any radiation therapy or surgery
- No treatment with any other investigational therapy within 4 weeks prior to baseline disease assessments
- No history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix) within the last 5 years
- No patients with untreated brain metastases or patients that have not recovered from treatment for brain metastases
- No known malabsorption syndrome or other condition that may impair absorption of study medication
- No comorbidity or condition which compromises compliance with this protocol as judged by the investigator or that would significantly complicate interpretation of the safety profile of CI-1033
- No patients having reproductive potential who are not using a method of birth control or who are pregnant or breastfeeding or have a positive pregnancy test during baseline
Who cannot join
- Prior exposure to CI-1033 or other agents that target the erbB receptor family; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments; hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments; 6 weeks for megestrol acetate (to exclude the possibility of a hormone-withdrawal response); patients with untreated brain metastases.
Trial locations and contacts
66 sites in 9 countries.
66 sites in 9 countries
United States42 sites
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0922
Pfizer Investigational Site
Arroyo Grande, California, 93420
Pfizer Investigational Site
Aurora, Colorado, 80010
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Brownstown, Michigan, 48183
Pfizer Investigational Site
Chicago, Illinois, 60637-1470
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Dearborn, Michigan, 48126
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Gallatin, Tennessee, 37066
Pfizer Investigational Site
Hermitage, Tennessee, 37076
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Kansas City, Kansas, 66112
Pfizer Investigational Site
Kansas City, Missouri, 64111
Pfizer Investigational Site
Kansas City, Missouri, 64131
Pfizer Investigational Site
Kansas City, Missouri, 64154
Pfizer Investigational Site
Lebanon, Tennessee, 37087
Pfizer Investigational Site
Lee's Summit, Missouri, 64064
Pfizer Investigational Site
Lenexa, Kansas, 66214
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Miami Beach, Florida, 33140
Pfizer Investigational Site
Montebello, California, 90640
Pfizer Investigational Site
Montgomery, Alabama, 36106
Pfizer Investigational Site
Murfreesboro, Tennessee, 37130
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
Nashville, Tennessee, 37205
Pfizer Investigational Site
Nashville, Tennessee, 37207
Pfizer Investigational Site
Nashville, Tennessee, 37211
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Plantation, Florida, 33324
Pfizer Investigational Site
Salt Lake City, Utah, 84112
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
The Bronx, New York, 10461
Pfizer Investigational Site
The Bronx, New York, 10467
Pfizer Investigational Site
Walla Walla, Washington, 99362
Pfizer Investigational Site
West Bloomfield, Michigan, 48322
Canada4 sites
Pfizer Investigational Site
Chicoutimi, Quebec, G7H 5H6
Pfizer Investigational Site
Hamilton, Ontario, L8V 5C2
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 4E6
Italy4 sites
Pfizer Investigational Site
Bologna, 40139
Pfizer Investigational Site
Forlì, 47100
Pfizer Investigational Site
Modena, 41100
Pfizer Investigational Site
Roma, 00144
United Kingdom4 sites
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
London, SE1 9RT
Pfizer Investigational Site
London, SW3 6JJ
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT
Belgium3 sites
Pfizer Investigational Site
Brussels, 1000
Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Leuven, 3000
France3 sites
Pfizer Investigational Site
Avignon, 84082
Pfizer Investigational Site
Paris, 75248
Pfizer Investigational Site
Paris, 75651
Ireland2 sites
Pfizer Investigational Site
Dublin
Pfizer Investigational Site
Galway
Spain2 sites
Pfizer Investigational Site
Madrid, Madrid, 28040
Pfizer Investigational Site
Madrid, Madrid, 28041
Sweden2 sites
Pfizer Investigational Site
Stockholm, 118 83
Pfizer Investigational Site
Stockholm, 17176
About this study
Official title: A Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer
CI-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).
- Conditions
- Breast Neoplasms
- Being tested
- CI-1033
- Medical subject headings
- Breast 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 metastatic breast cancer.
Secondary outcomes (4)
Secondary objectives include an assessment of safety and patient reported outcomes (eg, quality of life [QOL])
correlations between erbB expression and efficacy
exploratory analyses of soluble erbB-2 or other biomarkers
exploratory questions to measure the patient-reported impact of diarrhea and skin reactions will also be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2003 (estimated)
- Study startDec 2002
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- 168 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
- NCT00051051
- Sponsor's protocol ID
- 1033-011
- Status last verified
- Sep 2006
- First submitted
- 2 Jan 2003
- 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 Phase II, Randomized, Open-Label Study of Single Agent CI-1033 in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00051051
- Acronym / sponsor ID
- 1033-011
- Conditions
- Breast Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- May 2005 (actual)
- First posted
- 3 Jan 2003 (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-1033 is an experimental drug that acts as an inhibitor of erbB (EGFR) receptors, which may be involved in tumor growth. The primary objective of this study is to assess the antitumor activity of CI-1033 in patients with metastatic breast cancer. Patients with histologically confirmed metastatic (Stage IV) breast cancer and who have received no more than 2 prior cytotoxic chemotherapy regimens are eligible for this study. CI-1033 is administered orally. Patients are required to have blood tests periodically while receiving treatment and will be closely monitored throughout the study for possible side effects and response to treatment. Patients may not have received any prior treatment with other agents that target erbB receptors, including Herceptin (trastuzumab) or Iressa (gefitinib).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Female, at least 18 years of age
- Histologically confirmed diagnosis of breast cancer
- Metastatic (Stage IV) disease
- Progressive or recurrent disease following the most recent therapy
- No more than 2 different, prior cytotoxic chemotherapy regimens for metastatic disease
Key exclusion criteria (1 listed)
- Prior exposure to CI-1033 or other agents that target the erbB receptor family; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); immunotherapy (including Herceptin) or other biologic therapy within 2 weeks prior to baseline disease assessments; hormone therapy (including hormone replacement therapy) within 4 weeks prior to baseline disease assessments; 6 weeks for megestrol acetate (to exclude the possibility of a hormone-withdrawal response); patients with untreated 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 metastatic breast cancer.
4 secondary outcomes
Secondary objectives include an assessment of safety and patient reported outcomes (eg, quality of life [QOL])
correlations between erbB expression and efficacy
exploratory analyses of soluble erbB-2 or other biomarkers
exploratory questions to measure the patient-reported impact of diarrhea and skin reactions will also be assessed
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
66 sites in 9 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 Breast Neoplasms, run by Pfizer at 66 sites in 9 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 24 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 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 66 sites in United States, Canada, Italy, United Kingdom, Belgium and 4 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 metastatic breast cancer.. 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.