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TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

NCT02657005 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-02-12

Study results available
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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.

Conditions

  • Sarcoma, Ewing

Interventions

DRUG

TK216

Inhibitor of protein-protein interactions of EWS-FLI1 fusion protein

Sponsors & Collaborators

  • Oncternal Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • James Breitmeyer, MD · Oncternal Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2022-05-31
Completion
2022-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657005 on ClinicalTrials.gov