Trial · NCT01524692
Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma
NCT01524692, Phase 2, Completed, University of Virginia; results first posted 2018-05-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma. Trials, record NCT01524692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01524692
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma
- NCT number
- NCT01524692
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 35 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Adenoid Cystic Carcinoma
- Interventions
- Dovitinib (TKI258)
- First posted
- 2012-02-02
- Last updated
- 2018-11-09
- Results first posted
- 2018-05-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Objective Tumor Response Rate Following Treatment With TKI258 | From enrollment up to 36months | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by cross sectional imaging: 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. |
| Secondary | Estimate the Progression-free Survival Following Treatment With TKI258. | From enrollment up to first progression event | PFS is measured from enrollment up to first progression event (median= 8.2 months). 1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan. |
| Secondary | The Adverse Event Profile of TKI258 in Subjects Who Have ACC. | From enrollment up to 36months | Adverse events were collected per CTCAE v3. |
| Secondary | Quality of Life Measurements During TKI258 Treatment. | Baseline FACT-G questionnaire and FACT-G questionnaire at time of off-treatment visit (average of 8.2 months) | Participants were asked to fill out FACT-G (Functional Assessment of Chronic Illness Therapy) quality of life questionnaires at baseline and off-treatment visit (average 8.2 months). This scale measures physical well-being, social/family well-being, emotional well-being, and functional well-being on a 5 point Likert scale. Scores range from 0 to 4 on a Likert scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The raw score range for each subscale is 0-28 points and the total score range is 0-108. Higher values represent higher well-being in each functional subscale. The mean difference from baseline to off-study assessment are presented with range from minimum to maximum. |
| Secondary | Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas. | All patients provided pre-study scans with target lesions. The target lesions from pre-study scans were compared to the target lesions on the baseline scan at time 0. TG0 was measured from -6 months to time 0. TG1 is defined as time 0 to time 4 months. | Collect descriptive data about the change in tumor growth rates as measured by the change point method. Tumor growth rate is defined as the estimated slope (slope is then defined as Y1-Y0 divided by X1-X0) from tumor measurements taken prior to treatment (TG0). TG0 is compared with TG1 (tumor growth rate) as defined by the estimated slope after treatment (comparing time 0 to 4mo). Each patient's tumor growth profile is allowed one slope measured from pre-study (-6 months to time 0), and the other slope (time 0 to time 4 months). Change between those 2 slopes is reported. Slope is measured on a plot of time on the x axis and sum of longest diameters of RECIST target lesions on the y axis. The slope of the tumor growth curve (plotted as sum of longest diameters vs month since starting dovitinib) is measured at time points -6mo, 0, and 4 months. Pre-study scans (-6mo) were required of all patients and on-study scans were at times, 0, 2, 4months, 8months, 12mo, 16mo. |
| Secondary | Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus | Anticipated Reporting Date 2020 | Assess archival tumor samples for the expression of MYB protein and chromosomal rearrangements of the MYB locus. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Determine the Objective Tumor Response Rate Following Treatment With TKI258 | From enrollment up to 36months | 1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Estimate the Progression-free Survival Following Treatment With TKI258. | From enrollment up to first progression event | Months | MEDIAN | |
| SECONDARY | The Adverse Event Profile of TKI258 in Subjects Who Have ACC. | From enrollment up to 36months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Quality of Life Measurements During TKI258 Treatment. | Baseline FACT-G questionnaire and FACT-G questionnaire at time of off-treatment visit (average of 8.2 months) | All participants filled out quality of life questionnaires. | units on a scale | MEAN |
| SECONDARY | Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas. | All patients provided pre-study scans with target lesions. The target lesions from pre-study scans were compared to the target lesions on the baseline scan at time 0. TG0 was measured from -6 months to time 0. TG1 is defined as time 0 to time 4 months. | All treated patients were required to submit pre-study cross sectional imaging from preceeding 6months in order to establish pre-study tumor growth rates. On-study scans were performed at time 0, 2, 4 months, 8, months, 12 months, 16 months. | cm/month | MEAN |
| SECONDARY | Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus | Anticipated Reporting Date 2020 |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the Objective Tumor Response Rate Following Treatment With TKI258 | Single ARM Dovitinib Treatment | Partial Response | 2 | Participants | |
| Determine the Objective Tumor Response Rate Following Treatment With TKI258 | Single ARM Dovitinib Treatment | Stable Disease | 22 | Participants | |
| Determine the Objective Tumor Response Rate Following Treatment With TKI258 | Single ARM Dovitinib Treatment | Progressive Disease | 10 | Participants | |
| Estimate the Progression-free Survival Following Treatment With TKI258. | Single ARM Dovitinib Treatment | 8.2 | 90% Confidence Interval 7.3 to 11.0 | Months | |
| The Adverse Event Profile of TKI258 in Subjects Who Have ACC. | Patients With Any Adverse Event | 35 | Participants | ||
| Quality of Life Measurements During TKI258 Treatment. | Single ARM Dovitinib Treatment | Functional Well-being subscale mean difference | -4 | Full Range -12 to -1 | units on a scale |
| Quality of Life Measurements During TKI258 Treatment. | Single ARM Dovitinib Treatment | Physical Well-being subscale mean difference | -6 | Full Range -18 to 7 | units on a scale |
| Quality of Life Measurements During TKI258 Treatment. | Single ARM Dovitinib Treatment | Social Well-being mean Difference | -1 | Full Range -10 to 28 | units on a scale |
| Quality of Life Measurements During TKI258 Treatment. | Single ARM Dovitinib Treatment | Emotional Well-being mean Difference | -3 | Full Range -12 to 11 | units on a scale |
| Quality of Life Measurements During TKI258 Treatment. | Single ARM Dovitinib Treatment | Overall FACT-G mean difference | -13 | Full Range -44 to 20 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Single ARM Dovitinib Treatment | 35 | |
| Overall Study | COMPLETED | Single ARM Dovitinib Treatment | 32 | |
| Overall Study | NOT COMPLETED | Single ARM Dovitinib Treatment | 3 |
Source ClinicalTrials.gov
Adverse events36
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 | Anemia | Blood and lymphatic system disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | Constipation | Gastrointestinal disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | Diarrhea | Gastrointestinal disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | Mucositis | Gastrointestinal disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | Nausea/Vomiting | Gastrointestinal disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | Stomach Pain | Gastrointestinal disorders | Single ARM Dovitinib Treatment | 2 | 35 | |
| other | Fatigue | General disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | Urinary Tract Infection | Renal and urinary disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | Transaminitis | Hepatobiliary disorders | Single ARM Dovitinib Treatment | 1 | 35 | |
| other | GGT Elevation | Hepatobiliary disorders | Single ARM Dovitinib Treatment | 4 | 35 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single ARM Dovitinib Treatment | 16 | 35 |
| Total, other adverse events | Single ARM Dovitinib Treatment | 31 | 35 |
| Total, serious adverse events | Single ARM Dovitinib Treatment | 22 | 35 |
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/NCT01524692
GET https://conductscience.org/api/trials/v1/NCT01524692/events?page=2