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TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

Trial Status: Active

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.

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of Ewing sarcoma (including ESFT) in subjects with relapsed or refractory disease who have failed standard therapy

Exclusion Criteria

  • Symptomatic brain metastases

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Joanna Margaret Balducci
Phone: 310-206-2632

Colorado

Aurora
Children's Hospital Colorado
Status: ACTIVE

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Joseph A. Ludwig
Phone: 713-792-3626
Texas Children's Hospital
Status: ACTIVE

The study is currently in the "expansion" phase after finding the recommended phase 2 dose in the dose/schedule escalation cohorts. Eighteen patients will be enrolled in the expansion phase. Vincristine is administered starting cycle 1, along with a 14 day continuous infusion of TK216.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Oncternal Therapeutics, Inc

  • Primary ID TK216-01
  • Secondary IDs NCI-2016-00918
  • Clinicaltrials.gov ID NCT02657005