Carcinoma, Non-Small Cell LungPhase 1NCT00174356
PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
A Phase 1 study testing CI 1033, PACLITAXEL and CARBOPLATIN in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 7 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small Cell Lung
- What is being tested?
- CI 1033, PACLITAXEL and CARBOPLATIN
- How many people
- 39 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2002to Oct 2005
- Phase
- Phase 1
- 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
- At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory)
Who cannot join
- Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or treatment with investigational agents (including CI 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; brain metastases.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Louisville, Kentucky, 40207
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Skokie, Illinois, 60076
Pfizer Investigational Site
Tampa, Florida, 33612
About this study
Official title: A Phase 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel And Carboplatin As First-Line Chemotherapy In Patients With Advanced Non-Small Cell Lung Cancer
The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- CI 1033, PACLITAXEL, CARBOPLATIN
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CI 1033Drug
PACLITAXELDrug
CARBOPLATINDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6
Secondary outcomes (1)
To determine the recommended Phase 2 dose of CI 1033 in combination with paclitaxel and carboplatin for patients with advanced NSCLC; to further define the safety profile of the recommended Phase 2 dose combination in an expanded cohort (22 patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startDec 2002
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small Cell LungStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 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
- NCT00174356
- Sponsor's protocol ID
- A4161001
- Status last verified
- Jan 2006
- First submitted
- 9 Sep 2005
- 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 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel And Carboplatin As First-Line Chemotherapy In Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00174356
- Acronym / sponsor ID
- A4161001
- Conditions
- Carcinoma, Non-Small Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Oct 2005
- First posted
- 15 Sep 2005 (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 main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.
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)
- At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory)
Key exclusion criteria (1 listed)
- Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or treatment with investigational agents (including CI 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; 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 | – |
| PACLITAXEL | Drug | – |
| CARBOPLATIN | Drug | – |
Primary outcome
The primary objective is to evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6
1 secondary outcome
To determine the recommended Phase 2 dose of CI 1033 in combination with paclitaxel and carboplatin for patients with advanced NSCLC; to further define the safety profile of the recommended Phase 2 dose combination in an expanded cohort (22 patients)
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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CI 1033, PACLITAXEL and CARBOPLATIN in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 7 sites in 2 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 7 sites in United States, Canada. 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 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.
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 evaluate the overall safety profile, including dose-limiting toxicities and the maximum tolerated dose, of CI 1033 in combination with paclitaxel (225 mg/m2) and carboplatin (area under the concentration time curve [AUC] of 6. 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.