TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

  • STATUS
    Recruiting
  • End date
    Jun 21, 2021
  • participants needed
    45
  • sponsor
    Oncternal Therapeutics, Inc
Updated on 21 September 2020
Investigator
Oncternal Information
Primary Contact
Children's National Hospital (5.3 mi away) Contact
+8 other location
vincristine
refractory ewing sarcoma

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.

Description

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.

Details
Treatment TK216
Clinical Study IdentifierNCT02657005
SponsorOncternal Therapeutics, Inc
Last Modified on21 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 10 yrs?
Gender: Male or Female
Do you have Ewing's sarcoma?
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
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