TK216 in Patients With Relapsed or Refractory Ewing Sarcoma

Status Terminated

Clinical Trial 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.

Clinical Trial Description

The study has been expanded to explore single agent TK216 for longer treatment duration. Approximately 26 patients will be enrolled in this Cohort. ;

Study Design

Related Conditions & MeSH terms

Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Sarcoma, Ewing

Clinical Trial Details

NCT number	NCT02657005
Study type	Interventional
Source	Oncternal Therapeutics, Inc
Contact
Status	Terminated
Phase	Phase 1/Phase 2
Start date	August 2016
Completion date	June 2022

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05440786` - CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma	Phase 2
Completed	`NCT01661400` - Anti-Angiogenic Therapy Post Transplant (ASCR) for Pediatric Solid Tumors	Phase 1
Completed	`NCT03275818` - Trial of Nab-paclitaxel in Patients With Desmoid Tumors and Multiply Relapsed/Refractory Desmoplastic Small Round Cell Tumors and Ewing Sarcoma	Phase 2
Not yet recruiting	`NCT04890093` - Vincristine and Temozolomide in Combination With PEN-866 for Adolescents and Young Adults With Relapsed or Refractory Solid Tumors	Phase 1/Phase 2
Recruiting	`NCT05046314` - A Clinical Study of TK216 in Patients With Relapsed or Refractory Ewing's Sarcoma	Phase 2
Recruiting	`NCT06387485` - A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning	N/A
Active, not recruiting	`NCT02415816` - Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas	N/A
Active, not recruiting	`NCT03778996` - SM-88 Maintenance Therapy for Advanced Ewing's Sarcoma and as Salvage Therapy for Sarcoma	Phase 2
Terminated	`NCT02581384` - Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors	Phase 1/Phase 2
Enrolling by invitation	`NCT05772312` - Quality of Life of Patients With Bone Tumor of the Lower Limbs Treated With Salvage Surgery
Withdrawn	`NCT02557854` - HIFU Hyperthermia With Liposomal Doxorubicin (DOXIL) for Relapsed or Refractory Pediatric and Young Adult Solid Tumors	Phase 1
Terminated	`NCT03495921` - A Trial For Participants With Ewing's Sarcoma Treated With Vigil in Combination With Irinotecan and Temozolomide	Phase 3
Completed	`NCT05100368` - The Prognostic Value of Serum Biomarkers in Ewing's Sarcoma