TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Joanna Margaret Balducci
Phone: 310-206-2632

Colorado

Aurora
Children's Hospital Colorado
Status: Active
Name Not Available

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

North Carolina

Durham
Duke University Medical Center
Status: Active
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Joseph A. Ludwig
Phone: 713-792-3626
Texas Children's Hospital
Status: Active
Name Not Available

Trial Objectives and Outline

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.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Oncternal Therapeutics, Inc

Trial IDs

Primary ID TK216-01
Secondary IDs NCI-2016-00918
Clinicaltrials.gov ID NCT02657005