Trial · NCT01440959
Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258
NCT01440959, Phase 2, Completed, Asan Medical Center; results first posted 2014-03-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258. Trials, record NCT01440959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01440959
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dovitinib for Imatinib/Sumitinib-failed Gastrointestinal Stromal Tumors (GIST): TKI258
- NCT number
- NCT01440959
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Asan Medical Center
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- dovitinib
- First posted
- 2011-09-27
- Last updated
- 2020-01-18
- Results first posted
- 2014-03-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control Rate (DCR; OR + Stable Disease) | Up to 24 weeks | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Progressive disease (PD), \>20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD), Insufficient change to qualify for PR or PD This was evaluated with abdominal and pelvic dynamic CT scan every 4 weeks for the initial 8 weeks, and then every 8 weeks. |
| Secondary | Overall Response Rate Using Both CT and PET Scans | Up to 24 weeks | PET scan will be performed at baseline and at 4 weeks of treatment. Metabolic response was defined based on the PET response criteria of the European Organization for Research and Treatment of Cancer (EORTC); a metabolic partial response (mPR) was defined as a 25% reduction in average SUVmax; metabolic stable disease (mSD) between a 25% decrease and 25% increase in average SUVmax; metabolic progressive disease (mPD) as a 25% increase in average SUVmax or the appearance of new uptake in metastatic lesions. |
| Secondary | Efficacy According to the Primary Mutation Type | Up to 24weeks | Correlation between efficacy results such as response, progression-free survival and overall survival, and primary mutation type including KIT exons 9, 11, 13, and 17 and PDGFRα exons 12 and 18. |
| Secondary | Efficacy According to the Concentrations of Circulating Growth Factors | Up to 24weeks | Correlation between efficacy results, such as response, progression-free survival, and overall survival andcirculating growth factors (including vascular endothelial growth factor, fibroblast growth factor, interleukin-8, placental growth factor, and fibroblast growth factor23), and soluble receptors (including soluble form of membrane bound vascular endothelial growth factor receptor-1 and -2). |
| Secondary | Number of Participants With Adverse Events | Monitoring of adverse events will be continued for at least 28 days following the last dose of study treatment, up to 3 year. | Adverse events will be graded according to Common Terminology Criteria for Adverse events version 3.0, up to 3 year. |
| Secondary | Progression-free Survival | Up to 3 years | Progression-free survival is defined as the time from the first treatment to the onset of progressive disease per RECIST criteria or to the date of death whichever comes first. For patients who do not experience progressive disease or death, the progression-free survival duration will be right censored on the last disease assessment date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions |
| Secondary | Overall Survival | Up to 3 years | Overall survival duration is calculated as time from the first treatment to the date of death. For patients who are still alive at the cut-off date for statistical reporting, the overall survival duration will be right censored on the last known alive date. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control Rate (DCR; OR + Stable Disease) | Up to 24 weeks | Percentage of participants | NUMBER | |
| SECONDARY | Overall Response Rate Using Both CT and PET Scans | Up to 24 weeks | Percentage of participants | NUMBER | |
| SECONDARY | Efficacy According to the Primary Mutation Type | Up to 24weeks | |||
| SECONDARY | Efficacy According to the Concentrations of Circulating Growth Factors | Up to 24weeks | |||
| SECONDARY | Number of Participants With Adverse Events | Monitoring of adverse events will be continued for at least 28 days following the last dose of study treatment, up to 3 year. | participants | NUMBER | |
| SECONDARY | Progression-free Survival | Up to 3 years | months | MEDIAN | |
| SECONDARY | Overall Survival | Up to 3 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control Rate (DCR; OR + Stable Disease) | TKI258 | 13 | 95% Confidence Interval 4.7 to 30.3 | Percentage of participants | |
| Overall Response Rate Using Both CT and PET Scans | TKI258 | Response rate by CT | 3 | Percentage of participants | |
| Overall Response Rate Using Both CT and PET Scans | TKI258 | Response rate by PET | 13 | Percentage of participants | |
| Number of Participants With Adverse Events | TKI258 | 30 | participants | ||
| Progression-free Survival | TKI258 | 3.6 | 95% Confidence Interval 3.5 to 3.7 | months | |
| Overall Survival | TKI258 | 9.7 | 95% Confidence Interval 6.0 to 13.4 | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TKI258 | 30 | |
| Overall Study | COMPLETED | TKI258 | 30 | |
| Overall Study | NOT COMPLETED | TKI258 | 0 |
Source ClinicalTrials.gov
Adverse events24
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 | Neutropenia | Blood and lymphatic system disorders | TKI258 | 11 | 30 | |
| other | Anemia | Blood and lymphatic system disorders | TKI258 | 15 | 30 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | TKI258 | 13 | 30 | |
| other | Anorexia | Gastrointestinal disorders | TKI258 | 10 | 30 | |
| other | Nausea | Gastrointestinal disorders | TKI258 | 18 | 30 | |
| other | Vomiting | Gastrointestinal disorders | TKI258 | 12 | 30 | |
| other | Dyspepsia | Gastrointestinal disorders | TKI258 | 11 | 30 | |
| other | Diarrhea | Gastrointestinal disorders | TKI258 | 19 | 30 | |
| other | Asthenia | General disorders | TKI258 | 18 | 30 | |
| other | Hypertension | Cardiac disorders | TKI258 | 13 | 30 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TKI258 | ||
| Total, other adverse events | TKI258 | 30 | 30 |
| Total, serious adverse events | TKI258 | 8 | 30 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01440959
GET https://conductscience.org/api/trials/v1/NCT01440959/events?page=2