Solid TumorsNCT00798889
Rollover Protocol for Prior SU011248 Protocols
A study testing Sunitinib in people with Solid Tumors, run by Pfizer at 59 sites in 11 countries.
Trial summary
The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- 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
- 314 participants
- Where
- 59 sitesin 11 countries
- Study dates
- Mar 2004to 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
- Prior SU011248 Protocol.
- Eligible to continue SU011248 treatment.
Who cannot join
- Uncontrolled CNS metastasis.
- Unfit to receive SU011248.
Trial locations and contacts
59 sites in 11 countries.
59 sites in 11 countries
United States42 sites
Pfizer Investigational Site
Albuquerque, New Mexico, 87131-0001
Pfizer Investigational Site
Albuqurque, New Mexico, 87106
Pfizer Investigational Site
Ann Arbor, Michigan, 48109-0843
Pfizer Investigational Site
Aurora, Colorado, 80045
Pfizer Investigational Site
Birmingham, Alabama, 35233-2115
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Boston, Massachusetts, 02114
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Boston, Massachusetts, 02215
Pfizer Investigational Site
Cleveland, Ohio, 44195
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Farmington Hills, Michigan, 48334
Pfizer Investigational Site
Franklin, Tennessee, 37067
Pfizer Investigational Site
Gallatin, Tennessee, 37066
Pfizer Investigational Site
Hermitage, Tennessee, 37076
Pfizer Investigational Site
Houston, Texas, 77030-4009
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Lebanon, Tennessee, 37087
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Minneapolis, Minnesota, 55455-0392
Pfizer Investigational Site
Murfreesboro, Tennessee, 37130
Pfizer Investigational Site
Myrtle Beach, South Carolina, 29572
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
Nashville, Tennessee, 37212
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
San Francisco, California, 94115-1705
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Smyrna, Tennessee, 37167
Pfizer Investigational Site
St Louis, Missouri, 63110
United Kingdom4 sites
Pfizer Investigational Site
Leeds, LS9 7TF
Pfizer Investigational Site
London, NW1 2PG
Pfizer Investigational Site
London, SW3 6JJ
Pfizer Investigational Site
Newcastle upon Tyne, NE4 6BE
Australia3 sites
Pfizer Investigational Site
East Melbourne, Victoria, 3002
Pfizer Investigational Site
Heidelberg, Victoria, 3084
Pfizer Investigational Site
Randwick, New South Wales, 2031
Italy2 sites
Pfizer Investigational Site
Milan, 20133
Pfizer Investigational Site
Milan, 20141
Sweden2 sites
Pfizer Investigational Site
Lund
Pfizer Investigational Site
Stockholm
Netherlands1 site
Pfizer Investigational Site
Nijmegen, Gelderland, 6525 GA
About this study
Official title: A Treatment Protocol For Patients Continuing From A Prior SU011248 Protocol
The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol
- Conditions
- Solid Tumors
- Being tested
- Sunitinib
- Keywords
- Solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Sunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib | Experimental | Not described Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Treatment
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 posted26 Nov 2008 (estimated)
- Study startMar 2004
- 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 Solid TumorsStudies 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
- 314 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
- NCT00798889
- Sponsor's protocol ID
- A6181030
- Status last verified
- Dec 2012
- First submitted
- 25 Nov 2008
- Last updated
- 21 Jan 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 21 Jan 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
- NCT00798889
- Acronym / sponsor ID
- A6181030
- Conditions
- Solid Tumors
- Keywords
- Solid tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 21 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this protocol is to provide SU011248 treatment for patients who have participated in a SU011248 protocol and are eligible to enter this protocol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib | 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 (2 listed)
- Prior SU011248 Protocol.
- Eligible to continue SU011248 treatment.
Key exclusion criteria (2 listed)
- Uncontrolled CNS metastasis.
- Unfit to receive SU011248.
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 |
|---|---|---|
| SunitinibSunitinib dose varies according to the doses allowed in previous protocol. It is given once a day, orally with various schedules depending on the parent protocol | Drug | Sunitinib |
Primary outcome
Duration of Treatment
Time frame: Baseline up to Day 28 after last dose of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 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.
Related trials for Solid Tumors
RecruitingPhase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Carcinoma, Non-small-Cell Lung
RecruitingPhase 1
A Study of JNJ-95437446 in Participants With Advanced-Stage Solid Tumors
Advanced Stage Solid Tumors
RecruitingPhase 1/2
A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors
Hepatocellular Carcinoma (HCC), Metastatic Uveal Melanoma
RecruitingPhase 1
A Study of JNJ-1761981 in Participants With Solid Tumors
Neoplasms
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
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
59 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunitinib in people with Solid Tumors, run by Pfizer at 59 sites in 11 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 2 inclusion and 2 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 21 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, United Kingdom, Australia, Italy, Sweden and 6 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 21 Jan 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?
Duration of Treatment (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 21 Jan 2013.