Summary

Eligibility
for people ages 10 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
Noah Federman (ucla)

Description

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.

Official Title

A Phase 1, Dose Escalation Study of Intravenous TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

Details

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.

Keywords

Sarcoma, Ewing Sarcoma Neuroectodermal Tumors, Primitive, Peripheral

Eligibility

You can join if…

Open to people ages 10 years and up

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

You CAN'T join if...

  • Symptomatic brain metastases

Locations

  • UCLA Jonsson Comprehensive Cancer Center accepting new patients
    Los Angeles California 90095 United States
  • Oregon Health & Science University accepting new patients
    Portland Oregon 97239 United States

Lead Scientist at UC Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Oncternal Therapeutics, Inc
ID
NCT02657005
Phase
Phase 1
Study Type
Interventional
Last Updated