Trial · NCT01478373
Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib
NCT01478373, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-08-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib. Trials, record NCT01478373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01478373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Dovitinib in Patients With Gastrointestinal Stromal Tumors Refractory and/or Intolerant to Imatinib
- NCT number
- NCT01478373
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Gastrointestinal Stromal Tumors
- Interventions
- Dovitinib (TKI258)
- First posted
- 2011-11-23
- Last updated
- 2016-04-27
- Other registries' IDs
- eudract:2011-001725-24
- Results first posted
- 2015-08-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease | 12 Weeks | DCR is defined as the proportion of patients with a best overall response of Complete Responses (CR), Partial Response (PR) and Stable Disease (SD) at 12 weeks according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. |
| Secondary | Progression-free Survival (PFS) of Patients Treated With Dovitinib | 9 months | The PFS duration: time from entry into the study to the date of the first documented progression (assessed using conventional RECIST (version 1.1) or death due to any cause. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), 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 | Time to Treatment Failure (TTF)of Patients Treated With Dovitinib | 9 months | TTF: the date of entry into the study to the earliest date of the first objective tumor progression, date of death due to any cause, or date of discontinuation due to reasons other than 'Protocol deviation' or 'Administrative problems'. |
| Secondary | Duration of Response or Stable Disease (SD) | 9 months | Duration of response or SD: time from date of entry into study to earliest date of first objective tumor progression or death. DCR is defined as proportion of patients with best overall response of CR, PR and SD at 12 weeks according to RECIST (version 1.1). CR: Disappearance of all non-nodal target lesions. Any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1; PR: At least a 30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters. PD: At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. |
| Secondary | Time to Tumor Progression (TTP)of Patients Treated With Dovitinib | 9 months | TTP: time from the date of entry into the study to first documentation of tumor progression or death due to the underlying cancer. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), 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 Response Rate (ORR) of Patients Treated With Dovitinib | Baseline, 12 weeks | Outcome Measure Description: ORR: proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. |
| Secondary | Overall Survival (OS) of Patients Treated With Dovitinib | 21 months (9 months of estimated treatment plus 12 months of survival follow up) | Outcome Measure Description: OS: time from the date of entry into the study to the date of death due to any cause. A patient who has not died by the date of the analysis cut-off would have the OS censored at the time of the last contact before the cut-off date. |
| Secondary | DCR (CR+PR+SD) at the End of Treatment | Up to 9 months of estimated treatment | DCR is defined as the proportion of patients with a best overall response of CR, PR and SD at the end of dovitinib treatment according to RECIST (version 1.1). Complete Response (CR): Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm 1;Partial Response (PR): At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm2. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease | 12 Weeks | Full Analysis Set: all subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) of Patients Treated With Dovitinib | 9 months | Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Days | MEDIAN |
| SECONDARY | Time to Treatment Failure (TTF)of Patients Treated With Dovitinib | 9 months | Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Days | MEDIAN |
| SECONDARY | Duration of Response or Stable Disease (SD) | 9 months | Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Days | MEAN |
| SECONDARY | Time to Tumor Progression (TTP)of Patients Treated With Dovitinib | 9 months | Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Days | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) of Patients Treated With Dovitinib | Baseline, 12 weeks | Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Overall Survival (OS) of Patients Treated With Dovitinib | 21 months (9 months of estimated treatment plus 12 months of survival follow up) | Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Months | MEDIAN |
| SECONDARY | DCR (CR+PR+SD) at the End of Treatment | Up to 9 months of estimated treatment | Full Analysis Set: All subjects with histologically confirmed diagnosis of GIST who received at least one dose of study drug. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Antitumor Activity of Dovitinib in Terms of Disease Control Rate (DCR): Complete Response+Partial Response +Stable Disease | Dovitinib | 52.6 | 90% Confidence Interval 38.2 to 66.7 | Percentage of Participants | |
| Progression-free Survival (PFS) of Patients Treated With Dovitinib | Dovitinib | 141 | 90% Confidence Interval 86.0 to 225.0 | Days | |
| Time to Treatment Failure (TTF)of Patients Treated With Dovitinib | Dovitinib | 122.0 | 95% Confidence Interval 81.0 to 223.0 | Days | |
| Duration of Response or Stable Disease (SD) | Dovitinib | 193.2 | Standard Deviation 117.78 | Days | |
| Time to Tumor Progression (TTP)of Patients Treated With Dovitinib | Dovitinib | 141.0 | 95% Confidence Interval 85.0 to 229.0 | Days | |
| Overall Response Rate (ORR) of Patients Treated With Dovitinib | Dovitinib | 2.6 | 90% Confidence Interval 0.1 to 11.9 | Percentage of Participants | |
| Overall Survival (OS) of Patients Treated With Dovitinib | Dovitinib | NA | 95% Confidence Interval NA to NA | Months | |
| DCR (CR+PR+SD) at the End of Treatment | Dovitinib | 52.6 | 90% Confidence Interval 38.2 to 66.7 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Dovitinib | 39 | |
| Treatment Phase | COMPLETED | Dovitinib | 38 | |
| Treatment Phase | NOT COMPLETED | Dovitinib | 1 | |
| Survival Phase | STARTED | Dovitinib | 38 | |
| Survival Phase | COMPLETED | Dovitinib | 0 | |
| Survival Phase | NOT COMPLETED | Dovitinib | 38 |
Source ClinicalTrials.gov
Adverse events122
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 | Dovitinib | 6 | 39 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dovitinib | 3 | 39 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dovitinib | 3 | 39 | |
| other | Tinnitus | Ear and labyrinth disorders | Dovitinib | 2 | 39 | |
| other | Vertigo | Ear and labyrinth disorders | Dovitinib | 3 | 39 | |
| other | Dry eye | Eye disorders | Dovitinib | 2 | 39 | |
| other | Keratitis | Eye disorders | Dovitinib | 3 | 39 | |
| other | Lacrimation increased | Eye disorders | Dovitinib | 6 | 39 | |
| other | Ocular hyperaemia | Eye disorders | Dovitinib | 2 | 39 | |
| other | Periorbital oedema | Eye disorders | Dovitinib | 2 | 39 |
1 to 10 of 122Source ClinicalTrials.gov
See all 122 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dovitinib | ||
| Total, other adverse events | Dovitinib | 36 | 39 |
| Total, serious adverse events | Dovitinib | 16 | 39 |
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/NCT01478373
GET https://conductscience.org/api/trials/v1/NCT01478373/events?page=2