Gastrointestinal NeoplasmNCT00094029
A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248
A study testing Sutent in people with Gastrointestinal Neoplasm, run by Pfizer at 118 sites in 34 countries.
Trial summary
The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Neoplasm
- What is being tested?
- Sutent
- How many people
- Not given
- Where
- 118 sitesin 34 countries
- Study dates
- Sep 2004to Oct 2011
- Phase
- Expanded access
- 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 proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
- Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
- Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
- Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
- Male or Female, 18 years or older
- Resolution of all acute toxicities of prior therapies
- Adequate organ function
Who cannot join
- Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
- Symptomatic central nervous system metastases
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding.
Trial locations and contacts
118 sites in 34 countries.
118 sites in 34 countries
United States32 sites
Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Buffalo, New York, 14263
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Duarte, California, 91010
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Farmington Hills, Michigan, 48334
Pfizer Investigational Site
Gainesville, Florida, 32610
Pfizer Investigational Site
Gainsville, Florida, 32610
Pfizer Investigational Site
Madison, Wisconsin, 53792
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
New Bedford, Massachusetts, 02741
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Niles, Illinois, 60714
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Portland, Oregon, 97201
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Rochester, Minnesota, 55905
Pfizer Investigational Site
San Francisco, California, 94115-1705
Pfizer Investigational Site
Santa Monica, California, 90404
Pfizer Investigational Site
Seattle, Washington, 98109
Pfizer Investigational Site
Seattle, Washington, 98195
Pfizer Investigational Site
St Louis, Missouri, 63110-1010
Pfizer Investigational Site
St Louis, Missouri, 63110-1094
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
The Bronx, New York, 10466
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010-2931
Italy9 sites
Pfizer Investigational Site
Aviano (PN), 33081
Pfizer Investigational Site
Aviano, PN, 33081
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Candiolo (TO), Italy, 10060
Pfizer Investigational Site
Genova, 16132
Pfizer Investigational Site
Milan, 20133
Pfizer Investigational Site
Milan, 20141
Pfizer Investigational Site
Milan, 20162
Pfizer Investigational Site
Torino, 10153
Australia8 sites
Pfizer Investigational Site
Ashford SA, 5035
Pfizer Investigational Site
Auchenflower, Queensland, 4066
Pfizer Investigational Site
Auchenflower QLD, 4066
Pfizer Investigational Site
Bedford Park, South Australia, 5042
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
East Melbourne, Victoria, 3002
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Pfizer Investigational Site
Randwick, New South Wales, 2031
Canada6 sites
Pfizer Investigational Site
Calgary, Alberta, T2N 4N2
Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3V6
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5
Pfizer Investigational Site
Vancouver, British Columbia, V5Z 4E6
Pfizer Investigational Site
Winnipeg, Manitoba, R2H 2A6
Spain6 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08025
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28041
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33006
Pfizer Investigational Site
Seville, Sevilla, 41009
Pfizer Investigational Site
Valencia, Valencia, 46009
United Kingdom6 sites
Pfizer Investigational Site
Leeds, England, LS9 7TF
Pfizer Investigational Site
London, SW3 6JJ
Pfizer Investigational Site
London, W1T 3AA
Pfizer Investigational Site
Manchester, M20 4BX
Pfizer Investigational Site
Newcastle upon Tyne, NE4 6BE
Pfizer Investigational Site
Newcastle upon Tyne, NE7 7DN
Germany4 sites
Pfizer Investigational Site
Berlin, 13125
Pfizer Investigational Site
Cologne, 50937
Pfizer Investigational Site
Düsseldorf, 40479
Pfizer Investigational Site
München, 81377
Taiwan4 sites
Pfizer Investigational Site
Kaohsiung Hsien, 833
Pfizer Investigational Site
Taipei, 100
Pfizer Investigational Site
Taipei, 104
Pfizer Investigational Site
Taipei, 112
France3 sites
Pfizer Investigational Site
Bordeaux, 33076
Pfizer Investigational Site
Lyon, 69373
Pfizer Investigational Site
Marseille, 13385
India3 sites
Pfizer Investigational Site
Mumbai, Maharashtra, 400 012
Pfizer Investigational Site
New Delhi, National Capital Territory of Delhi, 110 029
Pfizer Investigational Site
Vellore, Tamil Nadu, 632 004
Turkey (Türkiye)3 sites
Pfizer Investigational Site
Ankara, 06100
Pfizer Investigational Site
Inciralti / Izmir, 35340
Pfizer Investigational Site
Istanbul, 34390
Austria2 sites
Pfizer Investigational Site
Graz, A-8036
Pfizer Investigational Site
Vienna, 1100
Belgium2 sites
Pfizer Investigational Site
Brussels, 1200
Pfizer Investigational Site
Leuven, 3000
Czechia2 sites
Pfizer Investigational Site
Brno, 656 53
Pfizer Investigational Site
Prague, 150 06
Denmark2 sites
Pfizer Investigational Site
Aarhus C, 8000
Pfizer Investigational Site
Herlev, 2730
Hong Kong2 sites
Pfizer Investigational Site
Happy Valley, Hong Kong, 0
Pfizer Investigational Site
Hong Kong
Israel2 sites
Pfizer Investigational Site
Tel Aviv, 64239
Pfizer Investigational Site
Tel HaShomer, 52621
Mexico2 sites
Pfizer Investigational Site
Guadalajara, Jalisco, 44240
Pfizer Investigational Site
Mexico City, Mexico City, 14000
Netherlands2 sites
Pfizer Investigational Site
Groningen, Provincie Groningen, 9713 GZ
Pfizer Investigational Site
Leiden, 2333 ZA
Singapore2 sites
Pfizer Investigational Site
Singapore, 169610
Pfizer Investigational Site
Singapore, 308433
South Korea2 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 138-736
Thailand2 sites
Pfizer Investigational Site
Bangkok, 10700
Pfizer Investigational Site
Ratchatawi, Bangkok
Slovakia1 site
Pfizer Investigational Site
Bratislava, Bratislava Region, 833 10
About this study
Official title: A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate
The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.
Read the detailed description
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181036 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.
- Conditions
- Gastrointestinal Neoplasm
- Being tested
- Sutent
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SutentDrug
Sutent, 25, 37.5, or 50 mg daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2004 (estimated)
- Study startSep 2004
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal NeoplasmStudies 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
- Expanded access
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
- NCT00094029
- Sponsor's protocol ID
- A6181036
- Status last verified
- Mar 2012
- First submitted
- 8 Oct 2004
- Last updated
- 9 Mar 2012
- Results posted
- No
Publications
Reichardt P, Kang YK, Rutkowski P, Schuette J, Rosen LS, Seddon B, Yalcin S, Gelderblom H, Williams CC Jr, Fumagalli E, Biasco G, Hurwitz HI, Kaiser PE, Fly K, Matczak E, Chen L, Lechuga MJ, Demetri GD. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405-13. doi: 10.1002/cncr.29220. Epub 2015 Jan 13.
PubMed 25641662Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. doi: 10.1093/annonc/mdq696. Epub 2011 Feb 2.
PubMed 21289369
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate
- ClinicalTrials.gov ID
- NCT00094029
- Acronym / sponsor ID
- A6181036
- Conditions
- Gastrointestinal Neoplasm
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Oct 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 permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.
Detailed description
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181036 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.
Study design
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 proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy
- Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies
- Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician
- Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment
- Male or Female, 18 years or older
Key exclusion criteria (5 listed)
- Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication
- Symptomatic central nervous system metastases
- Serious acute or chronic illness
- Current treatment on another clinical trial
- Pregnant or breastfeeding.
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 |
|---|---|---|
| SutentSutent, 25, 37.5, or 50 mg daily | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Derived from this study: PubMed 25641662Reichardt P, Kang YK, Rutkowski P, Schuette J, Rosen LS, Seddon B, Yalcin S, Gelderblom H, Williams CC Jr, Fumagalli E, Biasco G, Hurwitz HI, Kaiser PE, Fly K, Matczak E, Chen L, Lechuga MJ, Demetri GD. Clinical outcomes of patients with advanced gastrointestinal stromal tumors: safety and efficacy in a worldwide treatment-use trial of sunitinib. Cancer. 2015 May 1;121(9):1405-13. doi: 10.1002/cncr.29220. Epub 2015 Jan 13.
- Derived from this study: PubMed 21289369Dudeck O, Zeile M, Reichardt P, Pink D. Comparison of RECIST and Choi criteria for computed tomographic response evaluation in patients with advanced gastrointestinal stromal tumor treated with sunitinib. Ann Oncol. 2011 Aug;22(8):1828-33. doi: 10.1093/annonc/mdq696. Epub 2011 Feb 2.
- 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
118 sites in 34 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sutent in people with Gastrointestinal Neoplasm, run by Pfizer at 118 sites in 34 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 5 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: status not confirmed, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 118 sites in United States, Italy, Australia, Canada, Spain and 29 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094029, which also lists 2 linked publications.
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 Mar 2012.