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
|Condition or disease||Intervention/treatment||Phase|
|Von Hippel-Lindau Syndrome||Drug: Dovitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Trial of TKI 258 (Dovitinib) in Von Hippel-Lindau Syndrome|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
500 mg/day on a 5 day on, 2 day off schedule
500 mg (5 capsules) daily by mouth on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle (i.e. 5 days on, 2 days off schedule).
Other Name: TKI258
- Most Frequent & Most Serious Adverse Events: Safety of Dovitinib for 6 Months [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]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.
- Number of VHL Participants With Response at 6 Months [ Time Frame: Every 2 cycles (approximately 8 weeks) for 6 months ]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.
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): NCT01266070
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Eric Jonasch, MD||M.D. Anderson Cancer Center|