Study of Dovitinib (TKI258) in Adenoid Cystic Carcinoma (ACC)
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|ClinicalTrials.gov Identifier: NCT01524692|
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : May 7, 2018
Last Update Posted : November 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenoid Cystic Carcinoma||Drug: Dovitinib (TKI258)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Pilot Study of Dovitinib (TKI258) in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma.|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||December 2015|
Experimental: Single ARM Dovitinib treatment
Single ARM Dovitinib treatment
Drug: Dovitinib (TKI258)
500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient.
- Determine the Objective Tumor Response Rate Following Treatment With TKI258 [ Time Frame: 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.
- Estimate the Progression-free Survival Following Treatment With TKI258. [ Time Frame: 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.
- The Adverse Event Profile of TKI258 in Subjects Who Have ACC. [ Time Frame: From enrollment up to 36months ]Adverse events were collected per CTCAE v3.
- Quality of Life Measurements During TKI258 Treatment. [ Time Frame: 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.
- Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas. [ Time Frame: 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.
- Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus [ Time Frame: Anticipated Reporting Date 2020 ]Assess archival tumor samples for the expression of MYB protein and chromosomal rearrangements of the MYB locus.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524692
|United States, Virginia|
|University of Virginia Health System|
|Charlottesville, Virginia, United States, 22908|
|Principal Investigator:||Patrick Dillon, MD||University of Virginia Health System|