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Trial record 13 of 128 for:    Adenoid Cystic Carcinoma

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
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Patrick Dillon, MD, University of Virginia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Adenoid Cystic Carcinoma
Intervention Drug: Dovitinib (TKI258)
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Single ARM Dovitinib Treatment
Hide Arm/Group Description

Single ARM Dovitinib treatment

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.

Period Title: Overall Study
Started 35
Completed 32
Not Completed 3
Reason Not Completed
Withdrawal by Subject             3
Arm/Group Title Single ARM Dovitinib Treatment
Hide Arm/Group Description

Single ARM Dovitinib treatment

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.

Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 35 participants
56
(28 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
18
  51.4%
Male
17
  48.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   5.7%
White
30
  85.7%
More than one race
1
   2.9%
Unknown or Not Reported
1
   2.9%
ECOG Performance Status   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 35 participants
1
(0 to 2)
[1]
Measure Description:

ECOG PERFORMANCE STATUS

0 Fully active, able to carry on all pre-disease performance without restriction

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
  3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
  4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
  5. Dead
1.Primary Outcome
Title Determine the Objective Tumor Response Rate Following Treatment With TKI258
Hide Description 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.
Time Frame From enrollment up to 36months
Hide Outcome Measure Data
Hide Analysis Population Description
1 patient was not evaluable for response evaluation due to withdrawal prior to first interval scan.
Arm/Group Title Single ARM Dovitinib Treatment
Hide Arm/Group Description:

Single ARM Dovitinib treatment

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.

Overall Number of Participants Analyzed 34
Measure Type: Count of Participants
Unit of Measure: Participants
Partial Response
2
   5.9%
Stable Disease
22
  64.7%
Progressive Disease
10
  29.4%
2.Secondary Outcome
Title Estimate the Progression-free Survival Following Treatment With TKI258.
Hide Description 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.
Time Frame From enrollment up to first progression event
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single ARM Dovitinib Treatment
Hide Arm/Group Description:

Single ARM Dovitinib treatment

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.

Overall Number of Participants Analyzed 34
Median (90% Confidence Interval)
Unit of Measure: Months
8.2
(7.3 to 11.0)
3.Secondary Outcome
Title The Adverse Event Profile of TKI258 in Subjects Who Have ACC.
Hide Description Adverse events were collected per CTCAE v3.
Time Frame From enrollment up to 36months
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Any Adverse Event
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Patients with any adverse event as defined by CTCAE
Overall Number of Participants Analyzed 35
Measure Type: Count of Participants
Unit of Measure: Participants
35
 100.0%
4.Secondary Outcome
Title Quality of Life Measurements During TKI258 Treatment.
Hide Description 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.
Time Frame Baseline FACT-G questionnaire and FACT-G questionnaire at time of off-treatment visit (average of 8.2 months)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants filled out quality of life questionnaires.
Arm/Group Title Single ARM Dovitinib Treatment
Hide Arm/Group Description:

Single ARM Dovitinib treatment

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.

Overall Number of Participants Analyzed 35
Mean (Full Range)
Unit of Measure: units on a scale
Functional Well-being subscale mean difference
-4
(-12 to -1)
Physical Well-being subscale mean difference
-6
(-18 to 7)
Social Well-being mean Difference
-1
(-10 to 28)
Emotional Well-being mean Difference
-3
(-12 to 11)
Overall FACT-G mean difference
-13
(-44 to 20)
5.Secondary Outcome
Title Feasibility of Measuring and Analyzing TKI258 Induced Changes in the Growth Rate of Adenoid Cystic Carcinomas.
Hide Description 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.
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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Single ARM Dovitinib Treatment
Hide Arm/Group Description:

Single ARM Dovitinib treatment

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.

Overall Number of Participants Analyzed 35
Mean (Standard Error)
Unit of Measure: cm/month
Slope of Tumor growth rate from -6mo to time 0 1.95  (0.29)
Slope of tumor growth rate from 0 to 4 months 0.63  (0.18)
6.Secondary Outcome
Title Expression of MYB Protein and Chromosomal Rearrangements of the MYB Locus
Hide Description Assess archival tumor samples for the expression of MYB protein and chromosomal rearrangements of the MYB locus.
Time Frame Anticipated Reporting Date 2020
Outcome Measure Data Not Reported
Time Frame AE's and SAE's were collected from date of consent until off study date (which ranged from 0-20 months). Overall survival was collected from time of consent to June 2015 (40 months.)
Adverse Event Reporting Description AE reporting was completed using CTCAE 4.03
 
Arm/Group Title Single ARM Dovitinib Treatment
Hide Arm/Group Description

Single ARM Dovitinib treatment

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.

All-Cause Mortality
Single ARM Dovitinib Treatment
Affected / at Risk (%)
Total   16/35 (45.71%) 
Show Serious Adverse Events Hide Serious Adverse Events
Single ARM Dovitinib Treatment
Affected / at Risk (%)
Total   22/35 (62.86%) 
Blood and lymphatic system disorders   
Anemia *  1/35 (2.86%) 
Neutropenia *  1/35 (2.86%) 
Thromboembolic Event *  1/35 (2.86%) 
Cardiac disorders   
Hypertension *  1/35 (2.86%) 
Gastrointestinal disorders   
Constipation *  1/35 (2.86%) 
Diarrhea *  1/35 (2.86%) 
Mucositis *  1/35 (2.86%) 
Nausea/Vomiting *  1/35 (2.86%) 
Stomach Pain *  2/35 (5.71%) 
General disorders   
Fatigue *  1/35 (2.86%) 
Dehydration *  1/35 (2.86%) 
Pain *  2/35 (5.71%) 
Hepatobiliary disorders   
Transaminitis *  1/35 (2.86%) 
GGT Elevation *  4/35 (11.43%) 
Hypertriglyceridemia *  9/35 (25.71%) 
Psychiatric disorders   
Anxiety *  1/35 (2.86%) 
Renal and urinary disorders   
Urinary Tract Infection *  1/35 (2.86%) 
Skin and subcutaneous tissue disorders   
Acneiform Rash *  1/35 (2.86%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Single ARM Dovitinib Treatment
Affected / at Risk (%)
Total   31/35 (88.57%) 
Blood and lymphatic system disorders   
Anemia *  1/35 (2.86%) 
Neutropenia *  1/35 (2.86%) 
Thromboembolic Event *  1/35 (2.86%) 
Cardiac disorders   
Hypertension *  1/35 (2.86%) 
Gastrointestinal disorders   
Constipation *  1/35 (2.86%) 
Diarrhea *  1/35 (2.86%) 
Mucositis *  1/35 (2.86%) 
Nausea/Vomiting *  1/35 (2.86%) 
Stomach Pain *  2/35 (5.71%) 
General disorders   
Fatigue *  1/35 (2.86%) 
Dehydration *  1/35 (2.86%) 
Pain *  2/35 (5.71%) 
Hepatobiliary disorders   
Transaminitis *  1/35 (2.86%) 
GGT Elevation *  4/35 (11.43%) 
Metabolism and nutrition disorders   
Hypertriglyceridemia *  9/35 (25.71%) 
Psychiatric disorders   
Anxiety *  1/35 (2.86%) 
Renal and urinary disorders   
Urinary Tract Infection *  1/35 (2.86%) 
Skin and subcutaneous tissue disorders   
Acneiform Rash *  1/35 (2.86%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Patrick Dillon
Organization: University of Virginia
Phone: 4349821495
EMail: pmd5b@virginia.edu
Layout table for additonal information
Responsible Party: Patrick Dillon, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT01524692     History of Changes
Other Study ID Numbers: 15627
First Submitted: January 17, 2012
First Posted: February 2, 2012
Results First Submitted: October 25, 2017
Results First Posted: May 7, 2018
Last Update Posted: November 9, 2018