Spots Global Cancer Trial Database for TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
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Trial Identification
Brief Title: TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
Official Title: A Phase 1 / 2, Dose Escalation Study of Intravenous TK216 in Patients With Relapsed or Refractory Ewing Sarcoma
Study ID: NCT02657005
Conditions
Interventions
Study Description
Brief Summary: 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 Description: The study has been expanded to explore single agent TK216 for longer treatment duration. Approximately 26 patients will be enrolled in this Cohort.
Keywords
Eligibility
Minimum Age: 8 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Jonsson Comprehensive Cancer Center, Los Angeles, California, United States
Children's Hospital of Colorado, Aurora, Colorado, United States
Children's National Hospital, Washington, District of Columbia, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke Cancer Institute, Durham, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
Texas Children's Cancer & Hematology Centers, Baylor College, Houston, Texas, United States
UT MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: James Breitmeyer, MD
Affiliation: Oncternal Therapeutics
Role: STUDY_DIRECTOR
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