Carcinoma, Non-Small-Cell LungPhase 2NCT00092001
Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
A Phase 2 study testing Sunitinib in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 14 sites in 3 countries.
Trial summary
The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel. 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?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 14 sitesin 3 countries
- Study dates
- Jan 2005to Mar 2007
- 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 confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof
- No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy
- Evidence of measurable disease by radiographic technique
- Male or Female, 18 years or older
- ECOG performance status of 0 or 1
- Resolution of all acute toxicities of prior therapies
- Adequate organ function
Who cannot join
- Major surgery or radiation therapy within 4 weeks
- Severe hemorrhage within 4 weeks
- Previous treatment with anti-angiogenesis agents
- Diagnosis of second malignancy within last five 5 years
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
- Known HIV
Show all 9Show fewer
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding
Trial locations and contacts
14 sites in 3 countries.
14 sites in 3 countries
United States11 sites
Pfizer Investigational Site
Baltimore, Maryland, 21231-1000
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7600
Pfizer Investigational Site
Charlottesville, Virginia, 22908
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376
Pfizer Investigational Site
Clinton, North Carolina, 28382
Pfizer Investigational Site
Goldsboro, North Carolina, 27534
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15232
Pfizer Investigational Site
Pollocksville, North Carolina, 28573
Pfizer Investigational Site
St Louis, Missouri, 63110-1094
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Wilson, North Carolina, 27893
Spain2 sites
Pfizer Investigational Site
Badalona, Barcelona, 08916
Pfizer Investigational Site
Barcelona, BARCELONA, 08025
About this study
Official title: A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Sunitinib
- Keywords
- Non-small cell lung cancer, carcinoma, sunitinib, Phase 2
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sutent, SU011248
Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall confirmed objective response rate (ORR)
Measured: From screening until at least 28 days beyond discontinuation of study treatment.
Secondary outcomes (5)
Progression-free survival (PFS)
Measured: From screening until disease progression or discontinuation of study
Time to progression (TTP)
Measured: From screening until disease progression or discontinuation of study
Duration of response (DR)
Measured: From screening until disease progression or discontinuation of study
Overall survival (OS)
Measured: From screening until disease progression or discontinuation of study
Probability of survival at 1 year
Measured: From screening until disease progression or discontinuation of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2004 (estimated)
- Study startJan 2005
- Primary completionMar 2007
- Study completionMar 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
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
- NCT00092001
- Sponsor's protocol ID
- A6181040
- Status last verified
- Oct 2008
- First submitted
- 21 Sep 2004
- Last updated
- 16 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Efficacy And Safety Study Of SU011248 In Patients With Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00092001
- Acronym / sponsor ID
- A6181040
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Non-small cell lung cancer, carcinoma, sunitinib, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 27 Sep 2004 (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 test whether SU011248 has activity and is safe in patients with metastatic non-small cell lung cancer (NSCLC) who have failed a platinum-containing regimen and docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Sunitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed advanced or metastatic Non-Small Cell Lung Cancer that cannot be cured with surgery, radiation, or combination thereof
- No more than 2 prior chemotherapy treatments including treatment with a platinum containing therapy
- Evidence of measurable disease by radiographic technique
- Male or Female, 18 years or older
- ECOG performance status of 0 or 1
Key exclusion criteria (9 listed)
- Major surgery or radiation therapy within 4 weeks
- Severe hemorrhage within 4 weeks
- Previous treatment with anti-angiogenesis agents
- Diagnosis of second malignancy within last five 5 years
- History of or known brain metastases, spinal cord compression, or carcinomatous meningitis
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 |
|---|---|---|
| SunitinibAlso: Sutent, SU011248Sunitinib 50 mg by oral capsule daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity. | Drug | 1 |
Primary outcome
Overall confirmed objective response rate (ORR)
Time frame: From screening until at least 28 days beyond discontinuation of study treatment.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: From screening until disease progression or discontinuation of study
Time to progression (TTP)
Time frame: From screening until disease progression or discontinuation of study
Duration of response (DR)
Time frame: From screening until disease progression or discontinuation of study
Overall survival (OS)
Time frame: From screening until disease progression or discontinuation of study
Probability of survival at 1 year
Time frame: From screening until disease progression or discontinuation of study
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 16 Oct 2008.
- 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
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 14 sites in 3 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 7 inclusion and 9 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 16 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Spain, Italy. 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 confirmed objective response rate (ORR) (time frame: From screening until at least 28 days beyond discontinuation of study treatment.). 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 16 Oct 2008.