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