Trial · NCT00075218
A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
NCT00075218, Phase 3, Completed, Pfizer; results first posted 2009-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST). Trials, record NCT00075218. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00075218
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study To Assess The Safety And Efficacy Of SU11248 In Patients With Gastrointestinal Stromal Tumor(GIST)
- NCT number
- NCT00075218
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 361 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Gastrointestinal Stromal Tumor
- Interventions
- Placebo, SU011248
- First posted
- 2004-01-08
- Last updated
- 2009-09-28
- Results first posted
- 2009-09-28
- Limitations and caveats
- Duration of Tumor Response could not be reliably estimated at the time of analysis.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase | 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). |
| Primary | Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study | 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). |
| Secondary | Progression Free Survival (PFS) | Day 28 of each cycle : duration of double-blind treatment phase | 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). |
| Secondary | Overall Survival Status of Subjects | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | Number of subjects alive at end of study. |
| Secondary | Overall Survival | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | Time from date of randomization to date of death due to any cause. |
| Secondary | Overall Survival Based on the Rank Preserving Structural Failure Time Method | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | time from date of randomization to date of death due to any cause (rank preserving structural failure time method). |
| Secondary | Best Overall Tumor Response During Double-blind Treatment Phase | Day 28 of each cycle : duration of double-blind treatment phase | Tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST). |
| Secondary | Confirmed Objective Response (CR or PR) in Subjects | Day 28 of each cycle : duration of double-blind treatment phase | 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. |
| Secondary | Time to Tumor Response (TTR) | Day 28 of each cycle : duration of double-blind treatment phase | 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. |
| Secondary | Duration of Performance Status Maintenance | Day 28 of each cycle : duration of double-blind treatment phase | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase | Day 28 of each 6-week cycle : duration of double-blind treatment phase | 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. | weeks | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | Day 28 of each cycle : duration of double-blind treatment phase | ITT population | weeks | MEDIAN |
| SECONDARY | Overall Survival Status of Subjects | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | ITT population. | participants | NUMBER |
| SECONDARY | Overall Survival | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | ITT population; Number subjects Dead = 176, 90 (sunitinib, placebo respectively). Subjects who were not known to be dead at the time the database was closed for analysis were censored on the date they were last known to be alive. | weeks | MEDIAN |
| SECONDARY | Overall Survival Based on the Rank Preserving Structural Failure Time Method | clinic visit or telephone contact every 2 months for up to 3 years from the last dose of study drug | ITT population | weeks | MEDIAN |
| SECONDARY | Best Overall Tumor Response During Double-blind Treatment Phase | Day 28 of each cycle : duration of double-blind treatment phase | ITT population | participants | NUMBER |
| SECONDARY | Confirmed Objective Response (CR or PR) in Subjects | Day 28 of each cycle : duration of double-blind treatment phase | ITT population. | participants | NUMBER |
| SECONDARY | Time to Tumor Response (TTR) | Day 28 of each cycle : duration of double-blind treatment phase | ITT population. Number of subjects analyzed = number of subjects with tumor response. | weeks | MEDIAN |
| SECONDARY | Duration of Performance Status Maintenance | Day 28 of each cycle : duration of double-blind treatment phase | ITT Population. Number of subjects at median observed to have status worsening or died before status worsening. | weeks | MEDIAN |
| PRIMARY | Time to Tumor Progression (TTP) as Assessed in the Double-blind Treatment Phase at End of Study | Day 28 of each 6-week cycle : duration of double-blind treatment phase after Last Subject Last Visit (LSLV) | 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. | weeks | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase | Sunitinib Double-Blind Treatment | 27.3 | 95% Confidence Interval 16.0 to 32.1 | weeks | |
| Time to Tumor Progression (TTP) as Assessed by Imaging Studies at End of Double-blind Treatment Phase | Placebo Double-Blind Treatment | 6.4 | 95% Confidence Interval 4.4 to 10 | weeks | |
| Progression Free Survival (PFS) | Sunitinib Double-Blind Treatment | 22.9 | 95% Confidence Interval 10.9 to 28.0 | weeks | |
| Progression Free Survival (PFS) | Placebo Double-Blind Treatment | 6.0 | 95% Confidence Interval 4.4 to 9.7 | weeks | |
| Overall Survival Status of Subjects | Sunitinib Double-Blind Treatment | Dead | 176 | participants | |
| Overall Survival Status of Subjects | Placebo Double-Blind Treatment | Dead | 90 | participants | |
| Overall Survival Status of Subjects | Sunitinib Double-Blind Treatment | Alive | 67 | participants | |
| Overall Survival Status of Subjects | Placebo Double-Blind Treatment | Alive | 28 | participants | |
| Overall Survival | Sunitinib Double-Blind Treatment | 72.7 | 95% Confidence Interval 61.3 to 83.0 | weeks | |
| Overall Survival | Placebo Double-Blind Treatment | 64.9 | 95% Confidence Interval 45.7 to 96.0 | weeks |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Treatment | STARTED | Sunitinib Double-Blind Treatment | 243 | |
| Double-Blind Treatment | STARTED | Placebo Double-Blind Treatment | 118 | |
| Double-Blind Treatment | STARTED | Sunitinib Open-Label Treatment | 0 | |
| Double-Blind Treatment | Received Double-Blind Treatment | Sunitinib Double-Blind Treatment | 228 | |
| Double-Blind Treatment | Received Double-Blind Treatment | Placebo Double-Blind Treatment | 114 | |
| Double-Blind Treatment | Received Double-Blind Treatment | Sunitinib Open-Label Treatment | 0 | |
| Double-Blind Treatment | Crossed Over to Open-Label Treatment | Sunitinib Double-Blind Treatment | 152 | |
| Double-Blind Treatment | Crossed Over to Open-Label Treatment | Placebo Double-Blind Treatment | 103 | |
| Double-Blind Treatment | Crossed Over to Open-Label Treatment | Sunitinib Open-Label Treatment | 0 | |
| Double-Blind Treatment | COMPLETED | Sunitinib Double-Blind Treatment | 152 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events3,192
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib Double-Blind Treatment | 46 | 228 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Double-Blind Treatment | 10 | 114 | |
| other | Anaemia | Blood and lymphatic system disorders | Sunitinib Open-Label Treatment | 80 | 255 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib Double-Blind Treatment | 33 | 228 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo Double-Blind Treatment | 1 | 114 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sunitinib Open-Label Treatment | 64 | 255 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib Double-Blind Treatment | 33 | 228 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo Double-Blind Treatment | 1 | 114 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sunitinib Open-Label Treatment | 44 | 255 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sunitinib Double-Blind Treatment | 11 | 228 |
1 to 10 of 3,192Source ClinicalTrials.gov
See all 3,192 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib Double-Blind Treatment | ||
| Total, all-cause mortality | Placebo Double-Blind Treatment | ||
| Total, all-cause mortality | Sunitinib Open-Label Treatment | ||
| Total, other adverse events | Sunitinib Double-Blind Treatment | 223 | |
| Total, other adverse events | Placebo Double-Blind Treatment | 110 | |
| Total, other adverse events | Sunitinib Open-Label Treatment | 254 | |
| Total, serious adverse events | Sunitinib Double-Blind Treatment | 83 | |
| Total, serious adverse events | Placebo Double-Blind Treatment | 27 | |
| Total, serious adverse events | Sunitinib Open-Label Treatment | 122 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17046465 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sunitinib Double-Blind Treatment vs Placebo Double-Blind Treatment: Confirmed Objective Response (CR or PR) in Subjects | Trial comparisons |
| Sunitinib Double-Blind Treatment vs Placebo Double-Blind Treatment: Subjects With Pain Relief Response Using McGill Pain Questionnaire-present Pain Intensity (MPQ-PPI) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00075218
GET https://conductscience.org/api/trials/v1/NCT00075218/results?page=2