Trial · NCT00237185
A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene
NCT00237185, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2014-07-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene. Trials, record NCT00237185. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00237185
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Imatinib Mesylate in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors Expressing C-kit Gene
- NCT number
- NCT00237185
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 148 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
- Interventions
- Imatinib mesylate
- First posted
- 2005-10-12
- Last updated
- 2014-08-19
- Results first posted
- 2014-07-15
- Limitations and caveats
- No safety data was collected in the extension.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Tumor Response (Core) | Month 36 | Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response. |
| Primary | Best Tumor Response (Core + Extension) | Month 156 | Best tumor response was based on the Southwestern Oncology Group (SWOG) criteria. Objective tumor response assessments were categorized according to the following criteria: complete response (CR), partial response (PR), no change or stable disease (SD), progression of disease (PD), unknown where the progression has not been documented and one or more measurable or evaluable sites have not been assessed (UNK), status after resection for progression (RP), status after resection for safety (RS), status after preventive resection (RPR), progressive after first resection (PDR) and not evaluable. Any tumor assessment after surgical resection for preventative reasons was treated like tumor assessments of UNK for calculation of best response. Tumor assessments with current objective status = RP, RS or PDR were treated like assessments with objective tumor status = PD n the calculation of best response. |
| Secondary | Overall Survival (Core) | Date of first imatinib dose to the date of death during the core period, up to 36 months. | Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact. |
| Secondary | Overall Survival (Core + Extension) | Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months. | Overall survival was analyzed as time to event for all participants. Participants who did not die were censored at the last date known alive, which is the last date of any study medication, laboratory sample, tumor assessment, adverse event end date or date of last contact. |
| Secondary | Duration of Response (Core) | Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months. | Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD. |
| Secondary | Duration of Response (Core + Extension) | Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months | Duration of response was analyzed as time to event for all participants whose best response was at least a PR. The onset of response was the first tumor assessment that was subsequently confirmed to constitute at least a partial best response. The end of response was the first tumor assessment noting PD. |
| Secondary | Progression Free Survival (PFS) (Core + Extension) | Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months. | Progression free survival was analyzed as a time to event for each participant. If a participant had no event, then the PFS was censored at the last tumor assessment. |
| Secondary | Time to Treatment Failure (Core) | Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months. | Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis ate the time of their last tumor assessment. |
| Secondary | Time to Treatment Failure (Core + Extension) | Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month. | Time to treatment failure was analyzed as time to event for all participants. Participants who had neither progressed, died nor discontinued from the trial for any reason other than the condition no longer required therapy were censored for analysis at the time of their last tumor assessment. |
| Secondary | Time to Onset of Response (Core) | Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months. | Time to response was analyzed as time to event for all participants. Participants who did not meet the definition of confirmed PR/CR were censored at the time of their last progression-free tumor assessment. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Best Tumor Response (Core) | Month 36 | Treatment population: The treatment population included all randomized participants who received at least one dose of study medication. | participants | NUMBER |
| PRIMARY | Best Tumor Response (Core + Extension) | Month 156 | Treatment population: the treatment population included all participants who had at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Overall Survival (Core) | Date of first imatinib dose to the date of death during the core period, up to 36 months. | Treatment population: the treatment population included all participants who had at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Overall Survival (Core + Extension) | Date of first imatinib dose to the date of death during the core and extension periods, up to 156 months. | Treatment population: the treatment population included all participants who had at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Duration of Response (Core) | Date of confirmed best PR or CR to date of confirmed disease progression during the core period, up to 36 months. | Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR. | weeks | MEDIAN |
| SECONDARY | Duration of Response (Core + Extension) | Date of confirmed best PR or CR to date of confirmed disease progression during the core and extension periods, up to 156 months | Treatment population: the treatment population included all participants who had at least one dose of study medication and whose best response was at least a PR. | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) (Core + Extension) | Date of first imatinib dose to earliest date of progression, resection due to safety/progression, death due to any cause or discontinuation due to unsatisfactory therapeutic effect during the core and extension periods, up to 156 months. | Treatment population: the treatment population included all participants who had at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Time to Treatment Failure (Core) | Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core period, up to 36 months. | Treatment population: the treatment population included all participants who received at least one dose of study medication. | weeks | MEDIAN |
| SECONDARY | Time to Treatment Failure (Core + Extension) | Date of first imatinib dose to date of earliest occurrence of progression, death due to any cause, or discontinuation from the trial for any reason other than the condition no longer required therapy during the core and extension periods, up to 156 month. | Treatment population: the treatment population included all participants who received at least one dose of study medication. | months | MEDIAN |
| SECONDARY | Time to Onset of Response (Core) | Date of first imatinib dose to the date of the first tumor assessment that was later confirmed to be at least a partial response during the core period, up to 36 months. | Treatment population: the treatment population included all participants who received at least one dose of study medication. | weeks | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Best Tumor Response (Core) | Imatinib Mesylate 400 mg | Complete response | 0 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 600 mg | Complete response | 1 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 400 mg | Partial response | 49 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 600 mg | Partial response | 49 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 400 mg | Stable disease | 10 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 600 mg | Stable disease | 13 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 400 mg | Progressive disease | 12 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 600 mg | Progressive disease | 6 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 400 mg | Not evaluable | 2 | participants | |
| Best Tumor Response (Core) | Imatinib Mesylate 600 mg | Not evaluable | 3 | participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core | STARTED | Imatinib Mesylate 400 mg | 74 | |
| Core | STARTED | Imatinib Mesylate 600 mg | 74 | |
| Core | Treated Participants | Imatinib Mesylate 400 mg | 73 | |
| Core | Treated Participants | Imatinib Mesylate 600 mg | 74 | |
| Core | COMPLETED | Imatinib Mesylate 400 mg | 30 | |
| Core | COMPLETED | Imatinib Mesylate 600 mg | 37 | |
| Core | NOT COMPLETED | Imatinib Mesylate 400 mg | 44 | |
| Core | NOT COMPLETED | Imatinib Mesylate 600 mg | 37 | |
| Extension | STARTED | Imatinib Mesylate 400 mg | 24 | |
| Extension | STARTED | Imatinib Mesylate 600 mg | 32 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events398
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 NOS | Blood and lymphatic system disorders | Imatinib Mesylate 400 mg | 12 | 73 | |
| other | Anaemia NOS | Blood and lymphatic system disorders | Imatinib Mesylate 600 mg | 13 | 74 | |
| other | Leukopenia NOS | Blood and lymphatic system disorders | Imatinib Mesylate 400 mg | 4 | 73 | |
| other | Leukopenia NOS | Blood and lymphatic system disorders | Imatinib Mesylate 600 mg | 5 | 74 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib Mesylate 400 mg | 6 | 73 | |
| other | Neutropenia | Blood and lymphatic system disorders | Imatinib Mesylate 600 mg | 7 | 74 | |
| other | Conjunctival haemorrhage | Eye disorders | Imatinib Mesylate 400 mg | 3 | 73 | |
| other | Conjunctival haemorrhage | Eye disorders | Imatinib Mesylate 600 mg | 6 | 74 | |
| other | Conjunctival hyperaemia | Eye disorders | Imatinib Mesylate 400 mg | 2 | 73 | |
| other | Conjunctival hyperaemia | Eye disorders | Imatinib Mesylate 600 mg | 4 | 74 |
1 to 10 of 398Source ClinicalTrials.gov
See all 398 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Imatinib Mesylate 400 mg | ||
| Total, all-cause mortality | Imatinib Mesylate 600 mg | ||
| Total, other adverse events | Imatinib Mesylate 400 mg | 72 | 73 |
| Total, other adverse events | Imatinib Mesylate 600 mg | 73 | 74 |
| Total, serious adverse events | Imatinib Mesylate 400 mg | 46 | 73 |
| Total, serious adverse events | Imatinib Mesylate 600 mg | 40 | 74 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Imatinib Mesylate 400 mg vs Imatinib Mesylate 600 mg: serious adverse events |
Source 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/NCT00237185
GET https://conductscience.org/api/trials/v1/NCT00237185/results?page=2