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TKI 258 in Von Hippel-Lindau Syndrome (VHL)

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ClinicalTrials.gov Identifier: NCT01266070
Recruitment Status : Terminated (Trial met toxicity stopping rule)
First Posted : December 24, 2010
Results First Posted : February 13, 2017
Last Update Posted : February 13, 2017
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Von Hippel-Lindau Syndrome
Intervention Drug: Dovitinib
Enrollment 6
Recruitment Details Recruitment Period: November 16, 2012 to January 30, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Dovitinib
Hide Arm/Group Description Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
Period Title: Overall Study
Started 6
Completed 2
Not Completed 4
Reason Not Completed
Adverse Event             3
Protocol Violation             1
Arm/Group Title Dovitinib
Hide Arm/Group Description Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants
44
(18 to 62)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Hispanic or Latino
2
  33.3%
Not Hispanic or Latino
3
  50.0%
Unknown or Not Reported
1
  16.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  16.7%
White
3
  50.0%
More than one race
1
  16.7%
Unknown or Not Reported
1
  16.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months
Hide Description Most frequent & Most Serious Adverse Events: Safety of treatment with Dovitinib for 6 months in participants with VHL who have a measurable hemangioblastoma undergoing surveillance evaluated by toxicity scored using Common Toxicity Criteria (CTC) Version 4.0.
Time Frame Every 2 cycles (approximately 8 weeks) for 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovitinib
Hide Arm/Group Description:
Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Alanine aminotransferase increased
6
 100.0%
Alkaline phosphatase increased
6
 100.0%
Aspartate aminotransferase increased
6
 100.0%
Diarrhea
5
  83.3%
Dyspepsia
3
  50.0%
GGT Increased
5
  83.3%
Hyperglycemia
4
  66.7%
Hyperkalemia
4
  66.7%
Mucositis oral
4
  66.7%
Nausea
6
 100.0%
Rash maculo-papular
6
 100.0%
White Blood cell decreased
5
  83.3%
2.Secondary Outcome
Title Number of VHL Participants With Response at 6 Months
Hide Description Efficacy of treatment with dovitinib for 6 months in patients with VHL who have a measurable lesion evaluated by response using RECIST (Response Evaluation Criteria in Solid Tumors): Complete Response, Partial Response, Progressive Disease or Stable Disease.
Time Frame Every 2 cycles (approximately 8 weeks) for 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dovitinib
Hide Arm/Group Description:
Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Adverse events collected through 28 day treatment cycle, up to 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dovitinib
Hide Arm/Group Description Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
All-Cause Mortality
Dovitinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Dovitinib
Affected / at Risk (%) # Events
Total   0/6 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dovitinib
Affected / at Risk (%) # Events
Total   6/6 (100.00%)    
Eye disorders   
Blurred vision  1  1/6 (16.67%)  1
Gastrointestinal disorders   
Diarrhea  1  6/6 (100.00%)  12
Dyspepsia  1  3/6 (50.00%)  3
Mucositis oral  1  4/6 (66.67%)  4
Nausea  1  6/6 (100.00%)  9
Vomiting  1  2/6 (33.33%)  2
General disorders   
Abdominal pain  1  1/6 (16.67%)  1
Fatigue  1  2/6 (33.33%)  2
Pain (Dorsum of Left Foot)  1  1/6 (16.67%)  1
Pain (Tooth Pain)  1  1/6 (16.67%)  1
Infections and infestations   
Eye infection  1  1/6 (16.67%)  1
Tooth infection  1  1/6 (16.67%)  1
Urinary tract infection  1  2/6 (33.33%)  2
Investigations   
Alanine aminotransferase increased  1  6/6 (100.00%)  12
Alkaline phosphatase increased  1  6/6 (100.00%)  7
Aspartate aminotransferase increased  1  5/6 (83.33%)  5
Cholesterol high  1  1/6 (16.67%)  1
Creatinine increased  1  1/6 (16.67%)  1
GGT increased  1  5/6 (83.33%)  5
Lipase increased  1  2/6 (33.33%)  2
Lymphocyte count decreased  1  1/6 (16.67%)  1
Neutrophil count decreased  1  2/6 (33.33%)  2
Platelet count decreased  1  1/6 (16.67%)  1
Serum amylase increased  1  1/6 (16.67%)  1
White blood cell decreased  1  5/6 (83.33%)  5
Metabolism and nutrition disorders   
Hypercalcemia  1  1/6 (16.67%)  1
Hyperglycemia  1  4/6 (66.67%)  4
Hyperkalemia  1  4/6 (66.67%)  4
Hypertriglyceridemia  1  1/6 (16.67%)  1
Hypomagnesemia  1  2/6 (33.33%)  2
Nervous system disorders   
Headache  1  1/6 (16.67%)  1
Psychiatric disorders   
Agitation  1  1/6 (16.67%)  1
Anxiety  1  1/6 (16.67%)  1
Depression  1  1/6 (16.67%)  1
Personality change  1  1/6 (16.67%)  1
Reproductive system and breast disorders   
Erectile dysfunction  1  1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/6 (33.33%)  3
Skin and subcutaneous tissue disorders   
Dry skin  1  1/6 (16.67%)  1
Palmar-plantar erythrodysesthesia syndrome  1  1/6 (16.67%)  1
Pruritus  1  2/6 (33.33%)  2
Rash acneiform  1  1/6 (16.67%)  1
Rash maculo-papular  1  6/6 (100.00%)  13
Vascular disorders   
Hypertension  1  1/6 (16.67%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Eric Jonasch, MD/Professor, Genitourinary Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-7734
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01266070    
Other Study ID Numbers: 2010-0650
NCI-2011-00305 ( Registry Identifier: NCI CTRP )
First Submitted: December 22, 2010
First Posted: December 24, 2010
Results First Submitted: December 21, 2016
Results First Posted: February 13, 2017
Last Update Posted: February 13, 2017