Gastrointestinal Stromal TumorPhase 3NCT00075218

A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)

A Phase 3 study testing SU011248 in people with Gastrointestinal Stromal Tumor, run by Pfizer at 61 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Stromal Tumor
What is being tested?: SU011248
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 361 participants
Where: 61 sitesin 11 countries
Study dates: Dec 2003to May 2008
Phase: Phase 3
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

Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
Failed Gleevec treatment or intolerant to Gleevec therapy

Who cannot join

Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec

Trial locations and contacts

61 sites in 11 countries.

Country

City, postcode or hospital

61 sites in 11 countries

United States27 sites

Pfizer Investigational Site
Boston, Massachusetts, 02115
Pfizer Investigational Site
Cleveland, Ohio, 44195-0002
Pfizer Investigational Site
Columbus, Ohio, 43210
Pfizer Investigational Site
Columubs, Ohio, 43210
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Duarte, California, 91010
Pfizer Investigational Site
Durham, North Carolina, 27710
Pfizer Investigational Site
Los Angeles, California, 90095-6984
Pfizer Investigational Site
Los Angeles, California, 90095
Pfizer Investigational Site
Madison, Wisconsin, 53792-0001
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
Nashville, Tennessee, 37232
Pfizer Investigational Site
New York, New York, 10021-6007
Pfizer Investigational Site
New York, New York, 10022
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Park Ridge, Illinois, 60068
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
Portland, Oregon, 97201
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
Pfizer Investigational Site
Stanford, California, 94305
Pfizer Investigational Site
Tampa, Florida, 33612
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010

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Italy8 sites

Pfizer Investigational Site
Aviano, PN, 33081
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Candiolo, Torino, 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

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Australia7 sites

Pfizer Investigational Site
Ashford, South Australia, 5035
Pfizer Investigational Site
Auchenflower, Queensland, 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
Garran, Australian Capital Territory, 2605
Pfizer Investigational Site
Randwick, New South Wales, 2031

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United Kingdom4 sites

Pfizer Investigational Site
Leeds, LS9 7TF
Pfizer Investigational Site
London, W1T 3AA
Pfizer Investigational Site
Newcastle upon Tyne, NE4 6BE
Pfizer Investigational Site
Sutton, Surrey, SM2 5NG

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France3 sites

Pfizer Investigational Site
Lyon, 69373
Pfizer Investigational Site
Marseille, 13385
Pfizer Investigational Site
Villejuif, 94805

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Singapore3 sites

Pfizer Investigational Site
Singapore, 119074
Pfizer Investigational Site
Singapore, 169610
Pfizer Investigational Site
Singapore, 308433

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Spain3 sites

Pfizer Investigational Site
Barcelona, Barcelona, 08025
Pfizer Investigational Site
L'Hospitalet Del Llobregat, Barcelona, 08907
Pfizer Investigational Site
Madrid, Madrid, 28041

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Canada2 sites

Pfizer Investigational Site
Montreal, Quebec, H2L 4M1
Pfizer Investigational Site
Toronto, Ontario, M5G 1X5

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Netherlands2 sites

Pfizer Investigational Site
Groningen, Provincie Groningen, 9713 GZ
Pfizer Investigational Site
Rotterdam, South Holland, 3075 EA

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Belgium1 site

Pfizer Investigational Site
Leuven, 3000

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Switzerland1 site

Pfizer Investigational Site
Lausanne, CH-1011

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About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.

Conditions: Gastrointestinal Stromal Tumor
Being tested: Placebo, SU011248
Medical subject headings: Gastrointestinal Stromal Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.
SU011248Drug
50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.

Study groups in NCT00075218
Study group	Role	What they receive
B	Placebo comparator	Not described Receives: Drug: Placebo
A	Active comparator	Not described Receives: Drug: SU011248

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Measured: Day 28 of each 6-week cycle : duration of double-blind treatment phase
Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Measured: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)

Secondary outcomes (12)

Progression Free Survival (PFS)
Time from randomization to first documentation of objective tumor progression or to death due to any cause (on treatment or within 28 days of last dose).
Measured: Day 28 of each cycle : duration of double-blind treatment phase
Overall Survival Status of Subjects
Number of subjects alive at end of study.
Measured: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Overall Survival
Time from date of randomization to date of death due to any cause.
Measured: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Overall Survival Based on the Rank Preserving Structural Failure Time Method
time from date of randomization to date of death due to any cause (rank preserving structural failure time method).
Measured: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Best Overall Tumor Response During Double-blind Treatment Phase
Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST).
Measured: Day 28 of each cycle : duration of double-blind treatment phase
Confirmed Objective Response (CR or PR) in Subjects
Overall confirmed objective response = confirmed Complete Response (CR) OR confirmed Partial Response (PR) according to RECIST. Confirmed responses were those that persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.
Measured: Day 28 of each cycle : duration of double-blind treatment phase
Time to Tumor Response (TTR)
Time from date of randomization to first documentation of objective tumor response that was subsequently confirmed. TTR was only calculated for the subgroup of subjects with a confirmed objective tumor response.
Measured: Day 28 of each cycle : duration of double-blind treatment phase
Duration of Performance Status Maintenance
Time from randomization until the last time the performance status was no worse than at baseline or to death due to cancer in the absence of previous documentation of performance status worsening.
Measured: Day 28 of each cycle : duration of double-blind treatment phase
Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
25th Quartile: Time to Progression. Progression: a) No change (NC) in MPQ-PPI score (0=no pain to 5=excruciating pain) with increase total analgesic use >= 50% over baseline OR b) Increase score >= 1 point with either NC in total analgesic use or increase total analgesic use >= 50% over baseline. (50th Quartile not achieved.)
Measured: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
MPQ-PPI: 0=no pain to 5= excruciating pain. Pain Relief Response= 1) Decrease by >= 1 points in MPQ-PPI score with either Decrease or No Change in total analgesic use >= 50% over baseline OR 2) No change in MPQ-PPI score with Decrease total analgesic use >= 50% over baseline.
Measured: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)
Change: median score at observation minus median score at baseline. EQ-VAS score on the self-rated "thermometer," indicating the patient's own assessment of their health status from 0 (worst) to 100 (best) imaginable health state.
Measured: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Change From Baseline in EQ-5D Health State Profile Index
Change: median index score at observation minus median index score at baseline. EQ-5D is a generic instrument that describes health status in 5 dimensions (mobility, self-care, pain/discomfort, anxiety/depression, usual activities) with a weighted health Index based on general population values where where 0.0 = death and 1.0 = perfect health.
Measured: Day 1 & 28 of each cycle : duration of double-blind treatment phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2003May 2008

First posted8 Jan 2004 (estimated)
Study startDec 2003
Primary completionMay 2008
Study completionMay 2008

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastrointestinal Stromal TumorStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 361 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00075218
Sponsor's protocol ID: A6181004
Status last verified: Aug 2009
First submitted: 6 Jan 2004
Last updated: 28 Sep 2009
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.
PubMed 17046465

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Of SU011248 In The Treatment Of Patients With Imatinib Mesylate (Gleevec Tm, Glivec)-Resistant Or Intolerant Malignant Gastrointestinal Stromal Tumor
ClinicalTrials.gov ID: NCT00075218
Acronym / sponsor ID: A6181004
Conditions: Gastrointestinal Stromal Tumor
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 361 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2003
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 8 Jan 2004 (estimated)
Results: Posted 28 Sep 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A study to assess the safety and efficacy of SU11248 in patients with gastrointestinal stromal tumor (GIST) whose disease has failed imatinib therapy or who were intolerant to imatinib treatment.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
B	Placebo comparator	Drug: Placebo
A	Active comparator	Drug: SU011248

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Histologically-proven diagnosis of malignant GIST not amenable to surgery, radiation or combined modality treatment with curative intent
Failed Gleevec treatment or intolerant to Gleevec therapy

Key exclusion criteria (1 listed)

Treatment with any chemotherapy, chemoembolization therapy, immunotherapy, or investigational agent since the last dose of Gleevec

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
Placebo50 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.	Drug	B
SU01124850 mg taken orally once a day. 6 week treatment cycle (Schedule 4/2) 4 weeks on study drug/2 weeks off study drug.	Drug	A

Primary outcome

Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase
Time frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).
Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study
Time frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV)
Time from randomization to first documentation of objective tumor progression based on the assessment of an independent, third-party imaging laboratory using RECIST (Response Evaluation Criteria in Solid Tumors).

12 secondary outcomes

Progression Free Survival (PFS)
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Overall Survival Status of Subjects
Time frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Overall Survival
Time frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Overall Survival Based on the Rank Preserving Structural Failure Time Method
Time frame: clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug
Best Overall Tumor Response During Double-blind Treatment Phase
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Confirmed Objective Response (CR or PR) in Subjects
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Time to Tumor Response (TTR)
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Duration of Performance Status Maintenance
Time frame: Day 28 of each cycle : duration of double-blind treatment phase
Time to Pain Progression Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI)
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Change From Baseline Score in EuroQoL Visual Analog Scale (EQ-VAS)
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase
Change From Baseline in EQ-5D Health State Profile Index
Time frame: Day 1 & 28 of each cycle : duration of double-blind treatment phase

Results and safety

Results posted to the registry on 28 Sep 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib Double-Blind Treatment	243	152
Placebo Double-Blind Treatment	118	103
Sunitinib Open-Label Treatment	0	0

Primary outcome: Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase

Time frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase. Median (95% Confidence Interval). Unit: weeks

Measure	Sunitinib Double-Blind Treatment n = 207	Placebo Double-Blind Treatment n = 105
Value	27.3 (16.0 to 32.1)	6.4 (4.4 to 10)

Sunitinib Double-Blind Treatment vs Placebo Double-Blind Treatment: Hazard Ratio (HR): 0.329 (95% CI 0.233 to 0.466), p <0.001, Log Rank

Population analysed: From the Intent to Treat (ITT) population, 82 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 67 subjects on placebo were observed to have disease progression during blinded phase.

Primary outcome: Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study

Time frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV). Median (95% Confidence Interval). Unit: weeks

Measure	Sunitinib Double-Blind Treatment n = 243	Placebo Double-Blind Treatment n = 118
Value	26.6 (16.0 to 32.1)	6.4 (4.4 to 10.0)

Sunitinib Double-Blind Treatment vs Placebo Double-Blind Treatment: Hazard Ratio (HR): 0.339 (95% CI 0.244 to 0.472), p <0.001, Log Rank
Sunitinib Double-Blind Treatment vs Placebo Double-Blind Treatment: Hazard Ratio (HR): 0.327 (95% CI 0.232 to 0.460), p <0.001, Log Rank

Population analysed: From the Intent to Treat (ITT) population, 91 subjects on sunitinib treatment were observed to have disease progression during blinded phase and were included in TTP analysis. 73 subjects on placebo were observed to have disease progression during blinded phase.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib Double-Blind Treatment	83 of ?	223 of ?	Not reported
Placebo Double-Blind Treatment	27 of ?	110 of ?	Not reported
Sunitinib Open-Label Treatment	122 of ?	254 of ?	Not reported

Limitations and caveats (from the sponsor): Duration of Tumor Response could not be reliably estimated at the time of analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2009.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 17046465Demetri GD, van Oosterom AT, Garrett CR, Blackstein ME, Shah MH, Verweij J, McArthur G, Judson IR, Heinrich MC, Morgan JA, Desai J, Fletcher CD, George S, Bello CL, Huang X, Baum CM, Casali PG. Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: a randomised controlled trial. Lancet. 2006 Oct 14;368(9544):1329-38. doi: 10.1016/S0140-6736(06)69446-4.
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

61 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SU011248 in people with Gastrointestinal Stromal Tumor, run by Pfizer at 61 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 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 28 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Italy, Australia, United Kingdom, France 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2009). 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?

Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase (time frame: Day 28 of each 6-week cycle : duration of double-blind treatment phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00075218, which also lists 1 linked publication.

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 28 Sep 2009.