Summary

for people ages 10 years and up (full criteria)
at UCLA
study started
estimated completion
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

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.

Keywords

Sarcoma, Ewing Sarcoma

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
  • Children's Hospital of Colorado accepting new patients
    Aurora Colorado 80045 United States

Lead Scientist

Details

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