Gastrointestinal Stromal TumorPhase 3NCT00372567
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
A Phase 3 study testing sunitinib malate and imatinib mesylate in people with Gastrointestinal Stromal Tumor, run by Pfizer at 25 sites in 7 countries.
Trial summary
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. 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?
- sunitinib malate and imatinib mesylate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 25 sitesin 7 countries
- Study dates
- Jun 2007to Nov 2009
- 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
- Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.
Who cannot join
- Current treatment with any chemotherapy other than imatinib.
- Current treatment with any dose of imatinib other than 400 mg
Trial locations and contacts
25 sites in 7 countries.
25 sites in 7 countries
United States6 sites
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376
Pfizer Investigational Site
Creve Coeur, Missouri, 63141
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Farmington Hills, Michigan, 48334
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19111
Pfizer Investigational Site
St Louis, Missouri, 63110
United Kingdom6 sites
Pfizer Investigational Site
Glasgow, G12 0YH
Pfizer Investigational Site
Leeds, LS9 7TF
Pfizer Investigational Site
London, NW1 2PG
Pfizer Investigational Site
London, SW3 6JJ
Pfizer Investigational Site
London, W1
Pfizer Investigational Site
Manchester, M20 4BX
Hong Kong3 sites
Pfizer Investigational Site
Hong Kong, 0
Pfizer Investigational Site
Lai Chi Kok, Kowloon, 0
Pfizer Investigational Site
Tuenmen, New Territories, 0
Italy3 sites
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Milan, 20133
Pfizer Investigational Site
San Giovanni Rotondo, 71013
South Korea3 sites
Pfizer Investigational Site
Seoul, 110-744
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736
Germany2 sites
Pfizer Investigational Site
Göttingen, 37075
Pfizer Investigational Site
Hamburg, 22767
Spain2 sites
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Valencia, Valencia, 46009
About this study
Official title: A Phase IIIB, Randomized, Active Controlled Open-Label Study Of Sunitinib (Sutent) 37.5 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors (GIST) Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.
Read the detailed description
The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
- Conditions
- Gastrointestinal Stromal Tumor
- Being tested
- sunitinib malate, imatinib mesylate
- 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.
sunitinib malateDrug
Also called Sutent
37.5 mg daily
imatinib mesylateDrug
800mg daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: sunitinib malate |
| B | Active comparator | Not described Receives: Drug: imatinib mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.
Measured: Baseline, Week 5, and every 8 weeks until Year 2
Secondary outcomes (13)
Overall Survival (OS)
Time from date of randomization to the date of death. In the absence of confirmation of death, survival time was censored to the last date the participant was known to be alive.
Measured: Baseline up to 2 years
Time to Pain Relief Response (TTPR)
Pain relief response defined as a 50 percent (%) or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Measured: Day 28 of Cycle 1 up to 26
Time to Treatment Failure (TTF)
TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first.
Measured: Day 28 of Cycle 1 up to 26
Number of Participants With Objective Response of Complete Response or Partial Response
Number of participants with objective response based assessment of confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Day 28 of Cycle 1 up to 26
Time to Tumor Response (TTR)
Time from date of randomization to first documentation of objective tumor response (partial or complete response). Confirmed complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Day 28 of Cycle 1 up to 26
Duration of Response (DR)
Time from start of first documentation of objective response(complete or partial response) that was subsequently confirmed to first documentation of objective tumor progression or death due to any cause, whichever occurred first.
Confirmed complete response (CR) and partial response (PR)according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Measured: Day 28 of Cycle 1 up to 26
Time to Pain Progression (TTPP)
TTPP is the number of days from randomization to the first documentation of pain progression (defined as a 50% or more increase in MPQ-PPI score [0=no pain to 5=excruciating pain] or analgesic use from baseline for at least 3 consecutive weeks). Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Measured: Day 28 of Cycle 1 up to 26
Number of Participants With Pain Relief Response
Pain relief response defined as a 50% or more reduction in the McGill Pain Questionaire - Present Pain Intensity (MPQ-PPI) score (0=no pain to 5=excruciating pain) and/or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Measured: Day 28 of Cycle 1 up to 26
Number of Participants With Pain Progression
Pain progression defined as a 50% or more increase in MPQ-PPI score (0=no pain to 5=excruciating pain) or analgesic use from baseline for at least 3 consecutive weeks. Analgesic use scores were based on 1 point per non narcotic dose of medication and 4 points per dose of narcotic medication.
Measured: Day 28 of Cycle 1 up to 26
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Measured: Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Measured: Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single utility score. Health State Profile component rated current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicated better health state (no problems); 3 indicated worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigned utility value for each domain in the profile. Score was transformed and results in a total score ranged 0.21 to 1.000; higher score indicated a better health state.
Measured: Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm
EQ-5D: participant rated questionnaire assessed health-related quality of life in terms of a single index value. The VAS component rated current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicated a better health state.
Measured: Days 1 and 28 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2006 (estimated)
- Study startJun 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: See termination reason in detailed description.
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 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 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
- NCT00372567
- Sponsor's protocol ID
- A6181112
- Status last verified
- Mar 2011
- First submitted
- 5 Sep 2006
- Last updated
- 17 Mar 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, Randomized, Active Controlled Open-Label Study Of Sunitinib (Sutent) 37.5 Mg Daily Vs Imatinib Mesylate 800 Mg Daily In The Treatment Of Patients With Gastrointestinal Stromal Tumors (GIST) Who Have Had Progressive Disease While On 400 Mg Daily Of Imatinib
- ClinicalTrials.gov ID
- NCT00372567
- Acronym / sponsor ID
- A6181112
- Conditions
- Gastrointestinal Stromal Tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 69 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 7 Sep 2006 (estimated)
- Results
- Posted 31 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5 mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side effects of taking sunitinib or imatinib for approximately one year.
Detailed description
The study prematurely discontinued on July 27, 2009 due to poor recruitment and operational futility as a result of changes in clinical practice. There were no safety or efficacy concerns regarding the study in the decision to terminate the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: sunitinib malate |
| B | Active comparator | Drug: imatinib mesylate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib 400 mg daily.
Key exclusion criteria (2 listed)
- Current treatment with any chemotherapy other than imatinib.
- Current treatment with any dose of imatinib other than 400 mg
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 |
|---|---|---|
| sunitinib malateAlso: Sutent37.5 mg daily | Drug | A |
| imatinib mesylate800mg daily | Drug | B |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Baseline, Week 5, and every 8 weeks until Year 2
Time from randomization to the first documentation of tumor progression or death due to any cause in the absence of documented tumor progression, whichever was earlier.
13 secondary outcomes
Overall Survival (OS)
Time frame: Baseline up to 2 years
Time to Pain Relief Response (TTPR)
Time frame: Day 28 of Cycle 1 up to 26
Time to Treatment Failure (TTF)
Time frame: Day 28 of Cycle 1 up to 26
Number of Participants With Objective Response of Complete Response or Partial Response
Time frame: Day 28 of Cycle 1 up to 26
Time to Tumor Response (TTR)
Time frame: Day 28 of Cycle 1 up to 26
Duration of Response (DR)
Time frame: Day 28 of Cycle 1 up to 26
Time to Pain Progression (TTPP)
Time frame: Day 28 of Cycle 1 up to 26
Number of Participants With Pain Relief Response
Time frame: Day 28 of Cycle 1 up to 26
Number of Participants With Pain Progression
Time frame: Day 28 of Cycle 1 up to 26
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score- Sunitinib Treatment Arm
Time frame: Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Sunitinib Treatment Arm
Time frame: Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D) - Health State Profile Utility Score - Imatinib Treatment Arm
Time frame: Days 1 and 28 of each cycle
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) - Imatinib Treatment Arm
Time frame: Days 1 and 28 of each cycle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
- 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
25 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sunitinib malate and imatinib mesylate in people with Gastrointestinal Stromal Tumor, run by Pfizer at 25 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 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: stopped early, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, United Kingdom, Hong Kong, Italy, South Korea 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.
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 31 Dec 2010). 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?
Progression-Free Survival (PFS) (time frame: Baseline, Week 5, and every 8 weeks until Year 2). 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 17 Mar 2011.