NeoplasmsNCT00443534
A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.
A study testing SU011248 in people with Neoplasms, run by Pfizer at 62 sites in 7 countries.
Trial summary
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- SU011248
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 62 sitesin 7 countries
- Study dates
- May 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.
Who cannot join
- Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
Trial locations and contacts
62 sites in 7 countries.
62 sites in 7 countries
United States38 sites
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Bedford, Texas, 76022
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7600
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376
Pfizer Investigational Site
Clinton, North Carolina, 28328
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Fort Worth, Texas, 76177
Pfizer Investigational Site
Goldsboro, North Carolina, 27534
Pfizer Investigational Site
Grand Rapids, Michigan, 49503
Pfizer Investigational Site
Greenville, South Carolina, 29615
Pfizer Investigational Site
Greer, South Carolina, 29650
Pfizer Investigational Site
Hackensack, New Jersey, 07601
Pfizer Investigational Site
Harvey, Illinois, 60426-4265
Pfizer Investigational Site
Harvey, Illinois, 60426
Pfizer Investigational Site
Hershey, Pennsylvania, 17033
Pfizer Investigational Site
Hickory, North Carolina, 28602
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Las Vegas, Nevada, 89135
Pfizer Investigational Site
Littleton, Colorado, 80120
Pfizer Investigational Site
Maywood, Illinois, 60153
Pfizer Investigational Site
Munster, Indiana, 46321
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73120
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
San Antonio, Texas, 78207
Pfizer Investigational Site
San Antonio, Texas, 78217
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
San Antonio, Texas, 78258
Pfizer Investigational Site
Spartanburg, South Carolina, 29307
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Tinley Park, Illinois, 60477
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Tulsa, Oklahoma, 74133
Pfizer Investigational Site
Tulsa, Oklahoma, 74136
Pfizer Investigational Site
Wilson, North Carolina, 27893
Pfizer Investigational Site
Zion, Illinois, 60099
Italy6 sites
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Cremona, 26100
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Milan, 20133
Pfizer Investigational Site
Orbassano (TO), 10043
Pfizer Investigational Site
Rozzano (MI), 20089
Canada5 sites
Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Montreal, Quebec, H3G 1A4
Pfizer Investigational Site
Montreal, Quebec, H3G 1L5
Pfizer Investigational Site
Ottawa, Ontario, K1H 8L6
Germany4 sites
Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Großhansdorf, 22927
Pfizer Investigational Site
Hamburg, 20246
Pfizer Investigational Site
Wiesbaden, 65199
France3 sites
Pfizer Investigational Site
Lyon, 69373
Pfizer Investigational Site
Marseille, 13915
Pfizer Investigational Site
Villejuif, 94805
Spain3 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08003
Pfizer Investigational Site
Córdoba, Cordoba, 14004
Pfizer Investigational Site
Elche, Alicante, 03203
United Kingdom3 sites
Pfizer Investigational Site
London, SW3 6JJ
Pfizer Investigational Site
Manchester, M20 4BX
Pfizer Investigational Site
Sutton, Surrey, SM2 5PT
About this study
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.
- Conditions
- Neoplasms
- Being tested
- SU011248
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SU011248Drug
Also called Sutent/Sunitinib
Administered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: SU011248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Baseline up to Day 28 after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2007 (estimated)
- Study startMay 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443534
- Sponsor's protocol ID
- A6181078
- Status last verified
- Apr 2013
- First submitted
- 2 Mar 2007
- Last updated
- 24 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol.
- ClinicalTrials.gov ID
- NCT00443534
- Acronym / sponsor ID
- A6181078
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Mar 2007 (estimated)
- Results
- Posted 24 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This protocol allows subjects who have participated in a previous SU011248 protocol the ability to continue to receive SU011248 after their study has ended.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: SU011248 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participation in a previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit by remaining on SU011248 after the prior protocol ends.
Key exclusion criteria (1 listed)
- Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
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 |
|---|---|---|
| SU011248Also: Sutent/SunitinibAdministered orally in doses ranging from 25 to 50 mg once daily; dosing schedule and dosage depends on the patients dosing from the prior protocol | Drug | 1 |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Day 28 after last dose of study treatment
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
62 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SU011248 in people with Neoplasms, run by Pfizer at 62 sites in 7 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 24 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, Italy, Canada, Germany, France and 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to Day 28 after last dose 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 24 May 2013.