Lung NeoplasmsPhase 1/2NCT00074854
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy
A Phase 1/2 study testing CP-547,632 in people with Lung Neoplasms, run by Pfizer at 20 sites in United States.
Trial summary
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer. 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?
- CP-547,632
- How many people
- 87 participants
- Where
- 20 sitesUnited States
- Study dates
- May 2002to Mar 2005
- Phase
- Phase 1/2
- 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 confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc).
- Bidimensionally measurable disease >2cm x 1 cm by conventional CT Scan or >1 cm x 1cm by spiral CT Scan.
Who cannot join
- No tumors in close proximity to major veins or arteries.
- No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease.
- No evidence or history brain metastases.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Covington, Louisiana, 70433
Pfizer Investigational Site
Gallatin, Tennessee, 37066
Pfizer Investigational Site
Greenbrae, California, 94904
Pfizer Investigational Site
Hermitage, Tennessee, 37076
Pfizer Investigational Site
Lebanon, Tennessee, 37087
Pfizer Investigational Site
Metairie, Louisiana, 70002
Pfizer Investigational Site
Metairie, Louisiana, 70006
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
New Orleans, Louisiana, 70115
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
San Mateo, California, 94402
Pfizer Investigational Site
San Pablo, California, 94806
Pfizer Investigational Site
Smyrna, Tennessee, 37167
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
Tampa, Florida, 33612-9497
About this study
Official title: A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer.
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.
- Conditions
- Lung Neoplasms
- Being tested
- CP-547,632
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-547,632Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial.
Secondary outcomes (1)
Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2003 (estimated)
- Study startMay 2002
- Study completionMar 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT00074854
- Sponsor's protocol ID
- A3521002
- Status last verified
- Jul 2006
- First submitted
- 22 Dec 2003
- Last updated
- 9 Nov 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 Given In Combination With Chemotherapy (Paclitaxel And Carboplatin) Vs. Chemotherapy Alone For The Treatment Of Advanced Stage Non-Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00074854
- Acronym / sponsor ID
- A3521002
- Conditions
- Lung Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Study completion
- Mar 2005
- First posted
- 24 Dec 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.
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor when given in combination with chemotherapy (carboplatin and paclitaxel) is effective in the treatment of advanced stage non-small cell lung cancer.
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 (2 listed)
- Histologically or cytologically confirmed stage IIIB (inicluding those with pleural effusion), IV or recurrent non-small cell lung cancer (nsclc).
- Bidimensionally measurable disease >2cm x 1 cm by conventional CT Scan or >1 cm x 1cm by spiral CT Scan.
Key exclusion criteria (3 listed)
- No tumors in close proximity to major veins or arteries.
- No sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease.
- No evidence or history 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 |
|---|---|---|
| CP-547,632 | Drug | – |
Primary outcome
Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial.
1 secondary outcome
Given the outcome of the primary objective, analysis of secondary objectives were not formalized.
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 9 Nov 2006.
- 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
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CP-547,632 in people with Lung Neoplasms, run by Pfizer at 20 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 2 inclusion and 3 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 9 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 20 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Statistical estimates used on the Stage 1 data indicated low likely-hood of a positive outcome if the study continued to Stage 2. This provided the basis for discontinuation of the trial.. 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 9 Nov 2006.