Last updated on July 2018

TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

Brief description of study

Ewing sarcoma is characterized by genomic rearrangements resulting in over-expression of ets family transcription factors driving tumor progression. TK216 is designed to inhibit this effect by inhibiting downstream effects of the EWS-FLI1 transcription factor. This study is a first in human study of TK216 in subjects with Ewing sarcoma. The study is designed to establish initial safety and efficacy data in monotherapy and in combination with vincristine to assess the potential of TK216 for further development.

Detailed Study Description

TK216 is administered as a continuous intravenous infusion over 7-21 days depending on the dosing group. Administration is in cycles with a 14 day resting period between cycles. In the dose escalation segment of the study vincristine can be added after completion of 2 cycles of treatment with TK216 alone. After a "recommended phase 2 dose" has been determined in the dose escalation segment an expansion cohort will be initiated. In the expansion cohort combination treatment of TK216 and vincristine will start with cycle 1.

Clinical Study Identifier: NCT02657005

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Noah Federman, MD

UCLA Jonsson Comprehensive Cancer Center
Los Angeles, CA United States
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Paul A Meyers, MD

Memorial Sloan Kettering Cancer Center
New York, NY United States
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Joseph A Ludwig, MD

UT MD Anderson Cancer Center
Houston, TX United States
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Melissa Widener

Children's Hospital of Colorado
Aurora, CO United States
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Jodi A Muscal, MD

Texas Children's Cancer & Hematology Centers, Baylor College
Houston, TX United States
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