Trial · NCT00372567
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
NCT00372567, Phase 3, Terminated, Pfizer; results first posted 2010-12-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors. Trials, record NCT00372567. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00372567
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
- NCT number
- NCT00372567
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 69 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Gastrointestinal Stromal Tumor
- Interventions
- sunitinib malate, imatinib mesylate
- First posted
- 2006-09-07
- Last updated
- 2011-03-17
- Results first posted
- 2010-12-31
- Limitations and caveats
- On 18 June 2009, the study was prematurely stopped for operational reasons (poor recruitment, lack of interest, and change of clinical practice) and not related to safety concerns
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 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. |
| Secondary | Overall Survival (OS) | Baseline up to 2 years | 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. |
| Secondary | Time to Pain Relief Response (TTPR) | Day 28 of Cycle 1 up to 26 | 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. |
| Secondary | Time to Treatment Failure (TTF) | Day 28 of Cycle 1 up to 26 | TTF included death for any reason, treatment termination due to intolerable toxicity, or withdrawal of consent, whichever occurred first. |
| Secondary | Number of Participants With Objective Response of Complete Response or Partial Response | Day 28 of Cycle 1 up to 26 | 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. |
| Secondary | Time to Tumor Response (TTR) | Day 28 of Cycle 1 up to 26 | 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. |
| Secondary | Duration of Response (DR) | Day 28 of Cycle 1 up to 26 | 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. |
| Secondary | Time to Pain Progression (TTPP) | Day 28 of Cycle 1 up to 26 | 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. |
| Secondary | Number of Participants With Pain Relief Response | Day 28 of Cycle 1 up to 26 | 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. |
| Secondary | Number of Participants With Pain Progression | Day 28 of Cycle 1 up to 26 | 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. |
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 | Progression-Free Survival (PFS) | Baseline, Week 5, and every 8 weeks until Year 2 | Intention to treat (ITT): all participants in Main Study (Phase 3) who were randomized, regardless of whether the participant received any drug or received a different drug from that to which they were randomized. Number of participants analyzed: participants who had a PFS event (progressive disease or death). | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline up to 2 years | ITT | Months | MEDIAN |
| SECONDARY | Time to Pain Relief Response (TTPR) | Day 28 of Cycle 1 up to 26 | ITT | Days | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF) | Day 28 of Cycle 1 up to 26 | ITT; Number of participants analyzed: participants with treatment failure. | Months | MEDIAN |
| SECONDARY | Number of Participants With Objective Response of Complete Response or Partial Response | Day 28 of Cycle 1 up to 26 | ITT | Participants | NUMBER |
| SECONDARY | Time to Tumor Response (TTR) | Day 28 of Cycle 1 up to 26 | ITT | Weeks | MEDIAN |
| SECONDARY | Duration of Response (DR) | Day 28 of Cycle 1 up to 26 | ITT; Number of participants analyzed: participants with an objective tumor response. DR data censored on the day following the date of the last tumor assessment on study for participants who did not have objective tumor progression and who did not die due to any cause while on study. | Weeks | MEDIAN |
| SECONDARY | Time to Pain Progression (TTPP) | Day 28 of Cycle 1 up to 26 | ITT; Number of participants analyzed: participants with an event. | Days | MEDIAN |
| SECONDARY | Number of Participants With Pain Relief Response | Day 28 of Cycle 1 up to 26 | ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline. | Participants | NUMBER |
| SECONDARY | Number of Participants With Pain Progression | Day 28 of Cycle 1 up to 26 | ITT; Number of participants analyzed: participants with MPQ-PPI and analgesic use data at baseline. | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Sunitinib | 8.6 | 95% Confidence Interval 5.7 to 9.0 | Months | |
| Progression-Free Survival (PFS) | Imatinib | 6.4 | 95% Confidence Interval 4.5 to 15.7 | Months | |
| Overall Survival (OS) | Sunitinib (Phase 3) | 12.9 | 95% Confidence Interval 10.7 to 12.9 | Months | |
| Overall Survival (OS) | Imatinib | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Pain Relief Response (TTPR) | Sunitinib (Phase 3) | 34.0 | 95% Confidence Interval 11.0 to 57.0 | Days | |
| Time to Pain Relief Response (TTPR) | Imatinib | 22.0 | 95% Confidence Interval 8.0 to 113.0 | Days | |
| Time to Treatment Failure (TTF) | Sunitinib (Phase 3) | 8.2 | 95% Confidence Interval 5.5 to 9.0 | Months | |
| Time to Treatment Failure (TTF) | Imatinib | 6.3 | 95% Confidence Interval 4.5 to 8.2 | Months | |
| Number of Participants With Objective Response of Complete Response or Partial Response | Sunitinib (Phase 3) | 5 | Participants | ||
| Number of Participants With Objective Response of Complete Response or Partial Response | Imatinib | 2 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 Sub-study | STARTED | Sunitinib (Phase 3) | 0 | |
| Phase 1 Sub-study | STARTED | Imatinib | 0 | |
| Phase 1 Sub-study | STARTED | Sunitinib (Phase 1) | 12 | |
| Phase 1 Sub-study | COMPLETED | Sunitinib (Phase 3) | 0 | |
| Phase 1 Sub-study | COMPLETED | Imatinib | 0 | |
| Phase 1 Sub-study | COMPLETED | Sunitinib (Phase 1) | 12 | |
| Phase 1 Sub-study | NOT COMPLETED | Sunitinib (Phase 3) | 0 | |
| Phase 1 Sub-study | NOT COMPLETED | Imatinib | 0 | |
| Phase 1 Sub-study | NOT COMPLETED | Sunitinib (Phase 1) | 0 | |
| Phase 3 Study | STARTED | Sunitinib (Phase 3) | 31 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events148
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 | All Participants Who Received Sunitinib | 5 | 43 | |
| other | Anaemia | Blood and lymphatic system disorders | Imatinib | 2 | 25 | |
| other | Neutropenia | Blood and lymphatic system disorders | All Participants Who Received Sunitinib | 9 | 43 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib | 2 | 25 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | All Participants Who Received Sunitinib | 8 | 43 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Imatinib | 0 | 25 | |
| other | Hypothyroidism | Endocrine disorders | All Participants Who Received Sunitinib | 3 | 43 | |
| other | Hypothyroidism | Endocrine disorders | Imatinib | 1 | 25 | |
| other | Eyelid oedema | Eye disorders | All Participants Who Received Sunitinib | 0 | 43 | |
| other | Eyelid oedema | Eye disorders | Imatinib | 2 | 25 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants Who Received Sunitinib | ||
| Total, all-cause mortality | Imatinib | ||
| Total, other adverse events | All Participants Who Received Sunitinib | 43 | 43 |
| Total, other adverse events | Imatinib | 23 | 25 |
| Total, serious adverse events | All Participants Who Received Sunitinib | 11 | 43 |
| Total, serious adverse events | Imatinib | 5 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sunitinib (Phase 3) vs Imatinib: Number of Participants With Pain Progression | Trial comparisons |
| Sunitinib (Phase 3) vs Imatinib: Number of Participants With Objective Response of Complete Response or Partial Response | Trial comparisons |
| Sunitinib (Phase 3) vs Imatinib: Number of Participants With Pain Relief Response | Trial comparisons |
| All Participants Who Received Sunitinib vs Imatinib: serious adverse events | 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/NCT00372567
GET https://conductscience.org/api/trials/v1/NCT00372567/results?page=2