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TKI 258 in Von Hippel-Lindau Syndrome (VHL)

This study has been terminated.
(Trial met toxicity stopping rule)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01266070
First received: December 22, 2010
Last updated: December 21, 2016
Last verified: December 2015
Results First Received: December 21, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Von Hippel-Lindau Syndrome
Intervention: Drug: Dovitinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: November 16, 2012 to January 30, 2014. All recruitment done at The University of Texas MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Dovitinib 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

Participant Flow:   Overall Study
    Dovitinib
STARTED   6 
COMPLETED   2 
NOT COMPLETED   4 
Adverse Event                3 
Protocol Violation                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dovitinib 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

Baseline Measures
   Dovitinib 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Years]
Median (Full Range)
 44 
 (18 to 62) 
Gender 
[Units: Participants]
Count of Participants
 
Female      1  16.7% 
Male      5  83.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      2  33.3% 
Not Hispanic or Latino      3  50.0% 
Unknown or Not Reported      1  16.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
 
United States   6 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months   [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]

2.  Secondary:   Number of VHL Participants With Response at 6 Months   [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Eric Jonasch, MD/Professor, Genitourinary Medical Oncology
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01266070     History of Changes
Other Study ID Numbers: 2010-0650
NCI-2011-00305 ( Registry Identifier: NCI CTRP )
Study First Received: December 22, 2010
Results First Received: December 21, 2016
Last Updated: December 21, 2016